Search

Objectives: To evaluate the feasibility and acceptability of an emotional support programme for newly diagnosed people with multiple sclerosis. Design: Three-arm, mixed methods, randomised controlled trial comparing usual care, versus usual care plus nurse-specialist support, versus usual care plus nurse-specialist support plus peer support. Participants: Community-dwelling adults within two years of diagnosis or undergoing diagnosis. Interventions: PrEliMS involves information provision, emotional support, and strategies and techniques based on psychoeducation, Acceptance and Commitment Therapy principles, supportive listening. One version of the intervention was provided by nurse-specialists alone and the other was provided by nurse-specialists plus peer support. Main measures: The main outcome of interest was the feasibility of proceeding to a definitive trial, exploring recruitment rate, acceptability, completion of outcome measures (perceived stress, mood, self-efficacy, psychological impact, and service use), and signal of efficacy. Results: Of 40 participants randomised (mean age 36.2 years (SD = 14.8); 54% women; 85% with relapsing-remitting MS), 36 and 38 returned 3- and 6-month questionnaires, respectively. Participant interviews suggested the trial was largely feasible, and the intervention acceptable, with some amendments to trial procedures and intervention delivery noted. There were, however, no statistically significant differences between groups at followup for any measures, and effect-size estimates were small. Conclusion: A definitive trial combining nurse-specialist and peer support adjustment to diagnosis intervention is warranted, but more work exploring the delivery and fidelity of the intervention is needed before this is pursued [ABSTRACT FROM AUTHOR]

Objectives: To evaluate the delivery of rehabilitation using implicit motor learning principles in an acute stroke setting. Design: Pilot, assessor-blind, cluster randomised controlled trial with nested qualitative evaluation. Setting: Eight inpatient stroke units, UK. Participants: People within 14 days of stroke onset, presenting with lower limb hemiplegia. Interventions: Participants at control clusters received usual care. Participants at intervention clusters received rehabilitation using an Implicit Learning Approach (ILA); primarily consisting of reduced frequency instructions/feedback, and promotion of an external focus of attention. Video recording was used to understand the ability of intervention site therapists to adhere to the implicit learning principles, and to compare differences between groups. Measures: Ability to recruit and retain clusters/participants; suitability and acceptability of data collection processes; appropriateness of fidelity monitoring methods; and appropriateness of chosen outcome measures. Results: Eight stroke units participated, with four assigned to each group (intervention/control). Fifty-one participants were enrolled (intervention group 21; control group 30). Mean time since stroke was 6 days (SD 3.42; 0–14); mean age was 73 years (SD 14, 25–94). Of those approached to take part, 72% agreed. We found clear differences between groups with respect to the frequency and type of instructional statement. The ILA was acceptable to both patients and therapists. Conclusion: It is feasible to evaluate the application and effectiveness of motor learning principles within acute stroke rehabilitation, using a cluster randomised design. A larger study is required to evaluate the benefits of each approach; we provide a range of sample size estimates required for this. [ABSTRACT FROM AUTHOR]

Objective: This study aimed to explore perceptions regarding the sustainability of exercise following participation in a pre- and post-colorectal surgery exercise intervention trial (PREPARE-ABC). Design: Qualitative interview study. Data were analysed using framework analysis and independently coded by two researchers. Setting: Six United Kingdom National Health Service Trusts. Participants: Eighteen interviews (hospital-based exercise n = 9, home-based exercise n = 3, standard care n = 6) were conducted with patients 12–15 months after being randomised in the trial, after their 12 month appointment. Intervention: Individuals who participated in one of two exercise intervention groups (hospital-supervised or home-supported exercise) or a standard care control group of the PREPARE-ABC trial were invited to interview. Results: The exercise interventions were reported to influence participants' recovery and future sustainability of exercise behaviour change. Several participants continued to engage in exercise over a year after their surgery. Reasons for this included being engaged with exercise prior to diagnosis, psychological benefits of exercise and wanting to be engaged with something to help recovery. Perceptions about the sustainability of active lifestyles were influenced by confidence to engage in structured exercise or physical activity and beliefs about its potential to promote future wellness. Conclusions: Sustainability varies among individuals and early assessment of physical activity engagement could be beneficial. Physical activity interventions immediately following surgery may be important for future engagement. [ABSTRACT FROM AUTHOR]

Objective: Depth camera-based measurement has demonstrated efficacy in automated assessment of upper limb Fugl-Meyer Assessment for paralysis rehabilitation. However, there is a lack of adequately sized studies to provide clinical support. Thus, we developed an automated system utilizing depth camera and machine learning, and assessed its feasibility and validity in a clinical setting. Design: Validation and feasibility study of a measurement instrument based on single cross-sectional data. Setting: Rehabilitation unit in a general hospital Participants: Ninety-five patients with hemiparesis admitted for inpatient rehabilitation unit (2021–2023). Main measures: Scores for each item, excluding those related to reflexes, were computed utilizing machine learning models trained on participant videos and readouts from force test devices, while the remaining reflex scores were derived through regression algorithms. Concurrent criterion validity was evaluated using sensitivity, specificity, percent agreement and Cohen's Kappa coefficient for ordinal scores of individual items, as well as correlations and intraclass correlation coefficients for total scores. Video-based manual assessment was also conducted and compared to the automated tools. Result: The majority of patients completed the assessment without therapist intervention. The automated scoring models demonstrated superior validity compared to video-based manual assessment across most items. The total scores derived from the automated assessment exhibited a high coefficient of 0.960. However, the validity of force test items utilizing force sensing resistors was relatively low. Conclusion: The integration of depth camera technology and machine learning models for automated Fugl-Meyer Assessment demonstrated acceptable validity and feasibility, suggesting its potential as a valuable tool in rehabilitation assessment. [ABSTRACT FROM AUTHOR]

Objective: Feasibility test a co-developed intervention based on Acceptance and Commitment Therapy to support psychological adjustment post-stroke, delivered by a workforce with community in-reach. Design: Observational feasibility study utilising patient, carer, public involvement. Setting: Online. UK. Participants: Stroke survivors with self-reported psychological distress 4 + months post-stroke. Interventions: The co-developed Wellbeing After Stroke (WAterS) intervention includes: 9-weekly, structured, online, group sessions for stroke survivors, delivered via a training programme to upskill staff without Acceptance and Commitment Therapy experience, under Clinical Psychology supervision. Main measures: Feasibility of recruitment and retention; data quality from candidate measures; safety. Clinical and demographic information at baseline; patient-reported outcome measures (PROMs) via online surveys (baseline, pre- and post-intervention, 3 and 6 months after intervention end) including Mood (hospital anxiety and depression scale (HADS)), Wellbeing (ONS4), Health-Related Quality of Life (EQ5D5L), Psychological Flexibility (AAQ-ABI) and Values-Based Living (VQ). Results: We trained eight staff and recruited 17 stroke survivors with mild-to-moderate cognitive and communication difficulties. 12/17 (71%) joined three intervention groups with 98% attendance and no related adverse events. PROMS data were well-completed. The HADS is a possible future primary outcome (self-reported depression lower on average by 1.3 points: 8.5 pre-group to 7.1 at 3-month follow-up; 95% CI 0.4 to 3.2). Conclusion: The WAterS intervention warrants further research evaluation. Staff can be trained and upskilled to deliver. It appears safe and feasible to deliver online to groups, and study recruitment and data collection are feasible. Funding has been secured to further develop the intervention, considering implementation and health equality. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the feasibility of Acceptance and Commitment Therapy for people with acquired brain injury. Design: A process evaluation of the BrainACT treatment was conducted alongside a randomised controlled trial. Setting: Psychology departments of hospitals and rehabilitation centres. Subjects: Tweny-seven participants with acquired brain injury and 11 therapists. Intervention: BrainACT is an Acceptance and Commitment Therapy adapted for the needs and possible cognitive deficits of people with acquired brain injury, provided in eight one-hour face-to-face or video-conference sessions. Measurements: The attendance and compliance rates, engagement, satisfaction, and perceived barriers and facilitators for delivery in clinical practice were investigated using semi-structured interviews with participants and therapists and therapy logs. Results: 212 of the 216 sessions in total were attended and 534 of the 715 protocol elements across participants and sessions were delivered. Participants were motivated and engaged. Participants and therapists were satisfied with the intervention and participants reported to have implemented skills in their daily routines acquired during therapy. Key strengths are the structure provided with the bus of life metaphor, the experiential nature of the intervention, and the materials and homework. Participants and therapists often preferred face-to-face sessions, however, when needed video-conferencing is a good alternative. Conclusion: BrainACT is a feasible intervention for people with anxiety and depressive symptoms following acquired brain injury. However, when the content of the intervention is too extensive, we recommend adding two extra sessions. [ABSTRACT FROM AUTHOR]

Objective: Rehabilitation for adults with traumatic brain injury (TBI) incorporates client-centred goal-setting and motivational support to achieve goals. However, face-to-face rehabilitation is time-limited. New therapy approaches which leverage care are warranted. Conversational agents (CAs) offer a human–computer interface with which a person can converse. This study tested the feasibility, usability and acceptability of using a novel CA – RehabChat – alongside brain injury rehabilitation. Design: Mixed methods, single case design, feasibility pilot trial. Setting: Ambulatory and community brain injury rehabilitation. Participants: Adults with TBI receiving brain injury rehabilitation and clinicians providing this care. Intervention: Following 1:1 training, client–clinician dyads used RehabChat for two weeks alongside usual care. Main measures: Pre-post clinical measures (Motivation for Traumatic Brain Injury Rehabilitation Questionnaire, Rehabilitation Therapy Engagement Scale, Brain Injury Rehabilitation Trust Motivation Questionnaire-Relative, Brain Injury Rehabilitation Trust Motivation Questionnaire-Self) repeated measures (Hospital Anxiety and Depression Scale, researcher-developed wellbeing screening questions); and post-intervention (System Usability Scale (SUS), semi-structured 1:1 interview). Results: Six participants (two clients and four clinicians) completed training. Two client–clinician dyads completed the intervention. Two other clinicians used RehabChat in a mock client–clinician session. SUS scores indicated good usability. Client well-being did not deteriorate. No adverse events were experienced. Interviews indicated RehabChat was feasible, acceptable and easy to use; and supported motivation, goal-setting and completing practice activities. Conclusions: RehabChat was feasible and acceptable to use alongside usual ambulatory and community brain injury rehabilitation, had good usability and supported client needs. Further testing of RehabChat with a larger cohort for longer duration is warranted. [ABSTRACT FROM AUTHOR]

Objective: A diagnosis of Parkinson's often leads to uncertainty about the future and loss of perceived control. Peer support may offer a means to address these concerns and promote self-management. Design: A programme evaluation of the feasibility and potential effects of 'First Steps', utilising a pragmatic step wedge approach. Comparing First Steps (intervention) to (control) conditions. Setting: In the community at four sites in southern England. Participants: Newly diagnosed (≤ 12months) people with Parkinson's. Intervention: First Steps was a 2-day peer-conceived, developed and led intervention to support self-management. Main measures: At 0, 12 and 24 weeks anxiety and depression (Hospital, Anxiety and Depression Scale, HADS), daily functioning (World Health Organisation Disability Assessment Schedule, WHODAS), physical activity, quality of life (EQ5D), carer strain and service utilisation were assessed. Results: Between February 2018 and July 2019, 36 participants were enrolled into intervention and 21 to control conditions, all were included in statistical analysis. Lost to follow up was n = 1 (intervention) and n = 1 adverse event was reported (control, unrelated). Of the 36 allocated to the intervention n = 22 participants completed both days of First Steps during the study period. Completion of outcome measures was >95% at 24 weeks. Small effects favouring the intervention were found for HADS (odds ratio (OR) = 2.06, 95% confidence interval (CI) 0.24:17.84), Carer Strain Index (OR = 2.22, 95% CI 0.5:9.76) and vigorous (d = 0.42, 95% CI −0.12:0.97) and total physical activity (d = 0.41, 95% CI −0.13:0.95). EQ5D, WHOSDAS and service utilisation, was similar between groups. Conclusions: First Steps was feasible and safe and we found potential to benefit physical activity, mental health and carer strain. Further research with longer-term follow up is warranted. [ABSTRACT FROM AUTHOR]

Objective: Investigate feasibility and acceptability of prism adaptation training for people with inattention (spatial neglect), early after stroke, during usual care. Design: Phase II feasibility randomised controlled trial with 3:1 stratified allocation to standard occupational therapy with or without intervention, and nested process evaluation. Setting: Ten hospital sites providing in-patient stroke services. Participants: Screened positive for inattention more than one-week post-stroke; informal carers. Occupational therapists participated in qualitative interviews. Intervention: Adjunctive prism adaptation training at the start of standard occupational therapy sessions for three weeks. Main measures: Feasibility measures included recruitment and retention rates, intervention fidelity and attrition. Outcomes collected at baseline, 3 weeks and 12 weeks tested measures including Nottingham Extended Activities of Daily Living Scale. Acceptability was explored through qualitative interviews and structured questions. Results: Eighty (31%) patients were eligible, 57 (71%) consented, 54 randomised (40:13, +1 exclusion) and 39 (74%) completed 12-week outcomes. Treatment fidelity was good: participants received median eight intervention sessions (IQR: 5, 12) lasting 4.7 min (IQR: 4.1, 5.0). All six serious adverse events were unrelated. There was no signal that patients allocated to intervention did better than controls. Twenty five of 35 recruited carers provided outcomes with excellent data completeness. Therapists, patients and carers found prism adaptation training acceptable. Conclusions: It is feasible and acceptable to conduct a high-quality definitive trial of prism adaptation training within occupational therapy early after stroke in usual care setting, but difficult to justify given no sign of benefit over standard occupational therapy. Clinical trial registration: https://www.isrctn.com/ Ref ISRCTN88395268. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the safety, feasibility, and preliminary effectiveness of implementing supervised exercise programming into the clinical care of individuals with advanced cancer. Design: Single group implementation feasibility study using a pre–posttest design. Setting: Exercise Oncology Unit of the Spanish Cancer Association (a cancer-specific community facility outside the hospital setting). Participants: Adult individuals with advanced cancer profile involving advanced local cancer or distant metastases. Intervention: A 12-week, twice-weekly, supervised, clinic-based multi-component exercise program. Main Measure: Paired t -tests were used to assess pre–post changes and analyses of covariance were used to compare effects based on selected participant characteristics. Results: Eighty-four individuals with advanced cancer completed the baseline assessment, with six participants withdrawing prior to the start of the program. Of the 78 participants, 17 dropped out, thus, a total of 61 completed the final assessment. Mean adherence was 82.5%. No serious adverse events occurred. Exercise significantly improved VO2max by 5.2 mL·kg·min (p < 0.001), chest strength (p < 0.001), leg strength (p < 0.001), lean body mass (p = 0.003), skeletal muscle mass (p < 0.002), % body fat (p = 0.02), quality of life by 5.3 points (p = 0.009), fatigue by 3.2 points (p = 0.012), and physical activity by 1680 METs/week (p < 0.001). Conclusions: Our clinically supervised and tailored exercise program involving moderate to vigorous intensity exercise was found to be feasible, safe, and effective for individuals with advanced cancer. Implications for Cancer Survivors: With proper screening and supervision, individuals with advanced cancer can benefit from tailored exercise oncology support as part of an overall therapeutic care plan. [ABSTRACT FROM AUTHOR]

Objective: To test the feasibility of a telephone delivered intervention, informed by cognitive behavioural principles, for post-stroke fatigue, and estimated its effect on fatigue and other outcomes. Design: Randomised controlled parallel group trial. Setting: Three Scottish stroke services. Subjects: Stroke survivors with fatigue three months to two years post-stroke onset. Interventions: Seven telephone calls (fortnightly then a 'booster session' at 16 weeks) of a manualised intervention, plus information about fatigue, versus information only. Main measures: Feasibility of trial methods, and collected outcome measures (fatigue, mood, anxiety, social participation, quality of life, return to work) just before randomisation, at the end of treatment (four months after randomisation) and at six months after randomisation. Results: Between October 2018 and January 2020, we invited 886 stroke survivors to participate in postal screening: 188/886 (21%) returned questionnaires and consented, of whom 76/188 (40%) were eligible and returned baseline forms; 64/76 (84%) returned six month follow-up questionnaires. Of the 39 allocated the intervention, 23 (59%) attended at least four sessions. At six months, there were no significant differences between the groups (adjusted mean differences in Fatigue Assessment Scale −0.619 (95% CI −4.9631, 3.694; p = 0.768), the Generalised Anxiety Disorder 7 −0.178 (95% CI −3.823, 3.467, p = 0.92), and the Patient Health Questionnaire −0.247 (95% CI −2.935, 2.442, p = 0.851). There were no between-group differences in quality of life, social participation or return to work. Conclusion: Patients can be recruited to a trial of this design. These data will inform the design of further trials in post-stroke fatigue. [ABSTRACT FROM AUTHOR]

Objective: The objective of this study was to assess the feasibility of delivering Art skill-based Rehabilitation Training (ART), a novel upper limb motor training program, to patients with stroke as an adjunct to standard care in an inpatient setting. Design: Feasibility study. Setting: Inpatient stroke rehabilitation unit at a university hospital. Participants: Thirty-eight patients admitted to a stroke rehabilitation unit with upper limb motor impairment were enrolled in the ART program facilitated by trained non-healthcare professionals between December 2017 and June 2021. Intervention: The ART program included nine, one-hour sessions of supervised tracing and freehand drawing tasks completed with both hands. This program was intended to be delivered at a frequency of three times per week over a duration of 3 weeks or for the length of inpatient stay. Main outcome measures: Feasibility outcomes included ART program adherence, acceptability, and safety. Results: Thirty-two (84%) participants with subacute stroke completed the ART program and 30 (79%) were included in the study analysis. Participants completed 93–100% of the ART tasks in a median [IQR] of 8 [6–10] ART sessions over a median [IQR] duration of 15 [7–19] days. ART program facilitators effectively provided upper limb assistance to patients with more severe upper limb impairments. Adherence and acceptability were high and no study-related adverse events occurred. Conclusion: The ART program was feasible to deliver and highly acceptable to patients with stroke. Further research is warranted to explore the impact of ART on upper limb sensorimotor function and use. [ABSTRACT FROM AUTHOR]

Objective: Anxiety is common among persons with MS (PwMS), but widely accepted treatments are lacking. Group-based interventions delivered via telehealth are an accessible treatment option requiring clinical trial evidence to support feasibility and initial efficacy. We conducted a pilot feasibility trial of an online support group intervention to reduce anxiety in PwMS. Methods: A non-randomized, parallel arm clinical trial was conducted. A total of 31 PwMS were enrolled: 20 completed a 12-week telehealth-delivered support group intervention and 11 were assigned to a survey-only control group. Primary feasibility outcomes were adherence and completion rates. Primary efficacy outcome was anxiety, secondary outcomes were depression, loneliness, distress, self-efficacy, stress, and quality of life. Results: Twenty-six participants completed the study. Intervention group adherence (75%) and completion (85%) rates were acceptable. Results indicated a medium size between-group effect, suggesting a greater reduction in anxiety in the intervention group compared to the control group [ U = 39.50, p = 0.045, r = 0.39]. No group differences in other outcomes were observed. Conclusion: A telehealth-delivered support group intervention appears feasible for further study and shows initial efficacy for the reduction of anxiety in PwMS. [ABSTRACT FROM AUTHOR]

Objective: To determine the feasibility of adding coaching sessions to a website (MS INFoRM) that supports self-directed fatigue management for people with multiple sclerosis (PwMS). Design: Double-blind, parallel-group feasibility study. Participants and setting: Twenty-six PwMS, who experienced severe fatigue (fatigue severity scale > 5.4), were recruited from participants who were ineligible for the main trial testing on the MS INFoRM website. Intervention: Six 45-to-60-min sessions of one-on-one coaching plus access to the MS INFoRm website compared to two check-in phone calls plus access to the MS INFoRm website. Both study arms took place over 3 months. Main measures: Feasibility parameters included proportion eligible of those screened; proportion consented; missing data; retention and adherence rates. Acceptability was explored through qualitative interviews. Secondary outcomes (self-efficacy and fatigue impact) were measured at baseline and post-intervention. Results: 76 people were invited to participate in this add-on study. 40 were interested and screened: 32 were eligible, 26 consented, and were randomized (mean age: 48.5 yrs (SD: 8.7), mean disease duration: 11.5 yrs). Retention was 85% (22 out of 26). Coaching adherence was high (86% attended ⩾ 5 sessions). At 3 months, people in the intervention group showed more improvements in self-efficacy and fatigue impact compared to the comparison group, however, the difference was not statistically significant (p = 0.471 and p = 0.147, respectively). The intervention was well-received by the participants and there were no adverse events. Conclusion: Combining one-on-one coaching sessions along with web-based interventions is feasible and appreciated by the participants, and worth exploring further in a larger trial. [ABSTRACT FROM AUTHOR]

Objective: To test the feasibility of a pilot study for a future definitive trial investigating the effect of different meal service programs for old people living at home. Design: An 8-week randomized controlled trial was performed. Setting: Three municipalities in the Nordic country, Denmark. Subjects: Danish participants (≥65y) with reduced functionality. Intervention: Three different meal service programs 1) 24-h meals service, 2) Protein-rich meal service, and 3) Rehabilitation meal service, were developed and compared to standard care. Main Measures: The main outcome was study feasibility. Dietary intake, anthropometry, physical function, quality of life, readmissions and adverse events were also evaluated. Comparisons between participants receiving a meal service program and standard care were done by one-way ANOVA, chi-square test and Fishers exact test Results: A total of 592 subjects were assessed for eligibility and 13% (76/592) were recruited. Final analysis included 75% (57/76) of participants. The outcome measures seemed acceptable and feasible though eligibility, inclusion, and completion of the intervention were lower than expected. The 24-h meal service program managed to significantly increase the intake of protein (p = 0.049) and energy (p = 0.038) compared to the control group where reductions were seen. No other significant differences were found. Conclusions: The pilot study was feasible and several benefits for completers were seen. However, in a future definitive trial, inclusion criteria should be wider, more effort should be put on the time, training and focus of the personal in close contact to the older subjects and the intervention should be less comprehensive and more flexible. [ABSTRACT FROM AUTHOR]

Background: Impairments in body awareness are common after stroke and are associated with decreased participation and performance in everyday activities. Objectives: To explore the feasibility and safety of a body awareness program after stroke, and identify the preliminary efficacy of class-based lessons compared to home-based lessons on sensation, body awareness, motor impairment and quality of life. Methods: A two-armed pilot randomized controlled trial with a nested qualitative descriptive study was conducted. Individuals with a diagnosis of stroke (at least three months post injury) were randomized to either class-based face-to-face body awareness lessons or home-based individually performed body awareness lessons. Outcome measures were safety, feasibility, sensation, body awareness, motor impairment, self-efficacy and quality of life. Semi-structured interviews were used to allow greater exploration and understanding of participants' experience of the program. Results: Twenty participants were randomized, 16 participants completed the program. Feasibility was greater in the class-based group. No adverse events were detected. The class-based group led to improvement in body awareness (p = 0.002), quality of life (p = 0.002), and the arm (p = 0.025) and leg (p = 0.005) motor impairment scores. Qualitative data similarly indicated that the class-based group experienced a stronger sense of awareness, achievement and connection than the home-based group. Conclusions: Body awareness training was safe, feasible and acceptable in people with stroke. Individuals in the class-based group showed greater benefit compared to those receiving home-based therapy. [ABSTRACT FROM AUTHOR]

Objectives: To explore the feasibility of a full economic evaluation of usual care plus peer-befriending versus usual care control, and potential cost-effectiveness of peer-befriending for people with aphasia. To report initial costs, ease of instruments' completion and overall data completeness. Design: Pilot economic evaluation within a feasibility randomised controlled trial Setting: Community, England Participants: People with post-stroke aphasia and low levels of psychological distress Intervention: All participants received usual care; intervention participants received six peer-befriending visits between randomisation and four months Main measures: Costs were collected on the stroke-adapted Client Service Receipt Inventory (CSRI) for health, social care and personal out-of-pocket expenditure arising from care for participants and carers at 4- and 10-months post-randomisation. Health gains and costs were reported using the General Health Questionnaire-12 and the EQ-5D-5L. Mean (CI) differences for costs and health gains were reported and uncertainty represented using non-parametric bootstrapping and cost-effectiveness acceptability curves. Results: 56 participants were randomised. Mean age was 70.1 (SD 13.4). Most (n = 37, 66%) had mild and many (n = 14; 25%) severe aphasia. There was ≥94% completion of CSRI questions. Peer-befriending was higher in intervention arm (p < 0.01) but there were no significant differences in total costs between trial arms. Peer-befriending visits costed on average £57.24 (including training and supervision costs). The probability of peer-befriending being cost-effective ranged 39% to 66%. Conclusions: Economic data can be collected from participants with post-stroke aphasia, indicating a full economic evaluation within a definitive trial is feasible. A larger study is needed to demonstrate further cost-effectiveness of peer-befriending. [ABSTRACT FROM AUTHOR]

Objective: To assess the preliminary effects of a buddy-style intervention to improve exercise adherence. Design: A parallel-group, open-label, pilot randomized controlled trial. Setting: Adult day-care centers. Participants: Sixty-five disabled older adults. Interventions: All participants underwent a 12-week home exercise program, and the intervention group received a 5–10 min buddy-style intervention between older adults in the intervention group once weekly at an adult day-care center. Main measures: Based on the exercise log calendar, the number of days of exercise was assessed for each of the three phases: 1–4 weeks, 5–8 weeks, and 9–12 weeks. Short physical performance battery was measured at baseline and after 12 weeks. Results: Of the 590 screened older adults, 65 were recruited and 33 were assigned to the intervention group. One participant in each group withdrew before the program began, and four and five patients in the intervention and control groups, respectively, dropped out by the 12-week assessment. Analysis of covariance of the 28 and 26 patients in the intervention and control groups, respectively, for whom exercise log calendars could be retrieved, showed that the intervention group (24.4/28 days) exercised significantly more days than the control group (20.6/28 days) at 9–12 weeks (P = 0.009). In the between-group effect of the intention-to-treat analysis of short physical performance battery, walking and standing test (P = 0.790, P = 0.829) were not significantly different, and balance test (P = 0.049) was significantly better in the control group. Conclusions: There was a preliminary effect of the buddy-style intervention to improve exercise adherence. [ABSTRACT FROM AUTHOR]

Objectives: Develop and implement a Communication Enhanced Environment model and explore its effect on language activities for patients early after stroke. Method and design: Before-and-after pilot study. Setting: An acute/slow stream rehabilitation and a rehabilitation ward in a private hospital in Perth, Western Australia. Participants: Fourteen patients recruited within 21 days of stroke. Seven recruited during the before-phase (control group: patients with aphasia = 3, patients without aphasia = 4) and seven recruited in the after-phase (intervention group: patients with aphasia = 4, patients without aphasia = 3). Intervention: The intervention group exposed to a Communication Enhanced Environment model had access to equipment, resources, planned social activities and trained communication partners. Both groups received usual stroke care. Data collection: Hospital site champions monitored the availability of the intervention. Behavioural mapping completed during the first minute of each 5-minute interval over 12 hours (between 7 am and 7 pm) determined patient engagement in language activities. Results: Seventy-one percent of the Communication Enhanced Environment model was available to the intervention group who engaged in higher, but not significant (95% CI), levels of language activities (600 of 816 observation time points, 73%) than the control group (551 of 835 observation time points, 66%). Unforeseen reorganisation of the acute ward occurred during the study. Conclusions: Implementation of a Communication Enhanced Environment model was feasible in this specific setting and may potentially influence patients' engagement in language activities. The unforeseen contextual challenges that occurred during the study period demonstrate the challenging nature of the hospital environment and will be useful in future research planning. [ABSTRACT FROM AUTHOR]

Objective: To examine the association between self-reported activity pacing (a strategy to manage fatigue symptoms) and objectively-measured physical activity behaviours in adults with multiple sclerosis. Design: Single cross-sectional study Setting: Multiple sclerosis rehabilitation centre in Colchester, United Kingdom. Subjects: Twenty-one adults (59 ± 9 years) with multiple sclerosis. Main measures: Physical activity behaviours (activity level: activity counts per minute; activity variability: highest activity counts per minute each day divided by activity counts per minute on that day) were measured with accelerometers. Self-reported activity pacing (Activity Pacing and Risk of Overactivity Questionnaire), fatigue severity (Fatigue Severity Scale) and health-related quality of life (RAND-12-Item Short-Form Health Survey) were measured. Scatter plots were used to explore associations between measures. Results: Activity level was 258 ± 133 counts per minutes, activity variability was 4 ± 1, self-reported activity pacing was 3 ± 1, fatigue severity was 5 ± 2 and health-related quality of life was 43 ± 8. Increased self-reported activity pacing was associated with lower activity levels and less variability in daily activities. Conclusion: This investigation suggests that people with multiple sclerosis who have low physical activity levels could be inappropriately using activity pacing as a reactionary response to their multiple sclerosis symptoms. [ABSTRACT FROM AUTHOR]

Objective: Many patients with subacute stroke rely on the nonparetic arm and leg to propel manual wheelchairs. We designed a bimanual, lever-driven wheelchair (LARA) to promote overground mobility and hemiparetic arm exercise. This study measured the feasibility of using LARA to increase arm movement, achieve mobility, and improve arm motor recovery (clinicaltrials.gov/ct2/show/NCT02830893). Design: Randomized, assessor-blind, controlled trial. Setting: Two inpatient rehabilitation facilities. Subjects: Nineteen patients with subacute stroke (1 week to 2 months post-stroke) received 30 minutes extra arm movement practice daily, while admitted to inpatient rehabilitation (n = 10) or before enrollment in outpatient therapy (n = 9). Interventions: Patients were randomized to train with the LARA wheelchair (n = 11) or conventional exercises with a rehabilitation therapist (n = 8). Main measures: Number of arm movements per training session; overground speed; Upper Extremity Fugl-Meyer score at three-month follow-up. Results: Participants who trained with LARA completed 254 (median) arm movements with the paretic arm each session. For three participants, LARA enabled wheelchair mobility at practical indoor speeds (0.15–0.30 m/s). Fugl-Meyer score increased 19 ± 13 points for patients who trained with LARA compared to 14 ± 7 points with conventional exercises (P = 0.32). Secondary measures including shoulder pain and increased tone did not differ between groups. Mixed model analysis found significant interaction between LARA training and treatment duration (P = 0.037), informing power analysis for future investigation. Conclusions: Practising arm movement with a lever-driven wheelchair is a feasible method for increasing arm movement early after stroke. It enabled wheelchair mobility for a subset of patients and shows potential for improving arm motor recovery. [ABSTRACT FROM AUTHOR]

Objective: To investigate the feasibility and effectiveness of an online motivational interviewing training program for rehabilitation professionals. Design: Pre-post design with two groups. Setting: Private rehabilitation hospital and an academic medical center Subjects: Group 1 included 19 motivational interviewing-experienced rehabilitation professionals. Group 2 included 25 motivational interviewing-naïve rehabilitation professionals. Interventions: Group 1 was exposed to an online motivational training program and Group 2 was exposed to an online motivational training program and a live booster session. Main measures: Motivational interviewing communication skills were measured with an adapted Helpful Responses Questionnaire. Knowledge and attitudes were measured with an adapted Motivational Interviewing Knowledge and Attitudes Test. Confidence, importance, and feasibility for implementing motivational interviewing were measured using the Motivational Interviewing Rulers. Results: Group 1 showed improvement in communication skills (2.6/5–3.3/5; P < 0.05) and confidence (6.0/01–7.4/10; P < 0.01) after online training. Improvements seen in skills and confidence were maintained at three months. Group 2 showed improvement in skills (2.1/5–3.3/5; P < 0.001), knowledge (7.7/10–8.5/10; P < 0.01), confidence (6.4/10–7.5/10; P < 0.01), and importance (8.3/10–8.9/10; P < 0.05) after online training. At three-months post-booster, improvements in communication skills and knowledge were maintained. Conclusions: Online training can be a cost and time effective approach to improve rehabilitation professionals' skills in motivational interviewing. Follow-up training activities are needed to maintain the level of knowledge and skill improvement. [ABSTRACT FROM AUTHOR]

Objective: To investigate the feasibility and preliminary efficacy of a driving simulator intervention on driving outcomes following acquired brain injury. Design: Pilot randomised controlled trial. Setting: Occupational therapy driver assessment and rehabilitation service. Subjects: Individuals post-acquired brain injury aiming to return to driving. Intervention: Eight sessions of simulated driver training over four weeks, in addition to usual care. Control: Usual care only. Main measures: Feasibility outcomes: Participant recruitment and retention; data completeness; therapy attendance and fidelity; adverse events. Performance outcomes: on-road driving performance; Simulator Sickness Questionnaire; Brain Injury Driving Self-Awareness Measure and Driving Comfort Scale – Daytime, assessed at baseline and five weeks post-randomisation. Results: Out of 523 individuals screened, 22 (4%) were recruited and randomised, with 20 completing their allocated group (n = 12 Simulator, n = 8 Usual Care). For those who completed training, session attendance was 100% with simulator sickness rated, on average, as mild. Six individuals (50%) in the Simulator group failed the on-road assessment, versus two (25%) in the Usual Care group (P = 0.373). On average, the Simulator group reported a positive change in confidence ratings (M = 5.77, SD = 13.96) compared to the Usual Care group, who reported a negative change (M = −6.97, SD = 8.47), P = 0.034. The Simulator group (M = 0.67, SD = 3.34) demonstrated no significant change in self-awareness relative to the Usual Care group (M = −0.83, SD = 1.83, P = 0.325). Conclusions: With adjustments to inclusion criteria and recruitment strategies, it may be feasible to deliver the intervention and conduct a larger trial. There is potential benefit of simulator training for improving driver confidence after acquired brain injury. [ABSTRACT FROM AUTHOR]

Objective: To test the psychometric properties of a Chinese version of the Neurological Fatigue Index-Stroke (C-NFI-Stroke) in stroke survivors. Design: This was a validation study. Cross-cultural adaptation of the scale was conducted according to standard guidelines. Reliability, validity, responsiveness, and interpretability were measured. Setting: Self-help groups and a community center. Subjects: One hundred and twelve Chinese stroke survivors and 65 healthy Chinese older people living in the community. Interventions: Not applicable. Main measures: The C-NFI-Stroke, Fatigue Severity Scale, Mental Fatigue Scale, General Self-Efficacy Scale, and Geriatric Depression Scale were used. Results: Cronbach's α coefficients were 0.69–0.88; the item-level agreement was 70.4%–88.9%; the weighted Kappa value was 0.47–0.79; and the intra-class correlation coefficients were 0.88–0.93. The C-NFI-Stroke had no ceiling and floor effects. It had good content validity and had two factors, "lack of energy" and "tiredness/weakness." The confirmatory factor analysis showed a good fit to the model. The C-NFI-Stroke significantly correlated with existing fatigue scales (r s = 0.55–0.63), self-efficacy (r s = −0.31 to −0.37), and depressive symptoms (r s = 0.53–0.60). The C-NFI-Stroke could discern differences between stroke survivors and healthy older people. Conclusions: The C-NFI-Stroke is a reliable and valid tool for clinical and research use on people who have been diagnosed with stroke for a year or more, although its factor structure differs from that of the original English version. [ABSTRACT FROM AUTHOR]

Objective: To determine the feasibility and acceptability of peer-befriending, for people with aphasia. Design: Single-blind, parallel-group feasibility randomised controlled trial comparing usual care to usual care + peer-befriending. Participants and setting: People with aphasia post-stroke and low levels of distress, recruited from 5 NHS Hospitals and linked community services; their significant others; and 10 befrienders recruited from community. Intervention: Six 1-hour peer-befriending visits over three months. Main measures: Feasibility parameters included proportion eligible of those screened; proportion consented; missing data; consent and attrition rates. Acceptability was explored through qualitative interviews. Outcomes for participants and significant others were measured at baseline, 4- and 10-months; for peer-befrienders before training and after one/two cycles of befriending. Results: Of 738 patients identified, 75 were eligible of 89 fully screened (84%), 62 consented (83% of eligible) and 56 randomised. Attrition was 16%. Adherence was high (93% attended ⩾2 sessions, 81% all six). The difference at 10 months on the GHQ-12 was 1.23 points on average lower/better in the intervention arm (95% CI 0.17, −2.63). There was an 88% decrease in the odds of GHQ-12 caseness (95% CI 0.01, 1.01). Fourty-eight significant others and 10 peer-befrienders took part. Procedures and outcome measures were acceptable. Serious adverse events were few (n = 10, none for significant others and peer-befrienders) and unrelated. Conclusions: SUPERB peer-befriending for people with aphasia post-stroke experiencing low levels of distress was feasible. There was preliminary evidence of benefit in terms of depression. Peer-befriending is a suitable intervention to explore further in a definitive trial. Clinical trial registration-URL: http://www.clinicaltrials.gov Unique identifier: NCT02947776 Subject terms: Translational research, mental health, rehabilitation, quality and outcomes, stroke [ABSTRACT FROM AUTHOR]

Objective: To investigate an intensive asynchronous computer-based treatment delivered remotely with clinician oversight to people with aphasia. Design: Single-blind, randomized placebo-controlled trial. Setting: Free-standing urban rehabilitation hospital. Participants: Adults with aphasia (at least six months post-onset). Interventions: Experimental treatment was Web ORLA® (Oral Reading for Language in Aphasia) which provides repeated choral and independent reading aloud of sentences with a virtual therapist. Placebo was a commercially available computer game. Participants were instructed to practice 90 minutes/day, six days/week for six weeks. Main measures: Change in Language Quotient of the Western Aphasia Battery-Revised from pre-treatment to post-treatment and pre-treatment to six weeks following the end of treatment. Results: 32 participants (19 Web ORLA®, 13 Control) completed the intervention and post-treatment assessment; 27 participants (16 Web ORLA®, 11 Control) completed the follow-up assessment six weeks after treatment had ended. Web ORLA® treatment resulted in significant improvements in language performance from pre-treatment to immediately post-treatment (X = 2.96; SD = 4.32; P < 0.01; ES = 0.68) and from pre-treatment to six weeks following the end of treatment (X = 4.53; SD = 3.16; P < 0.001; ES = 1.43). There was no significant difference in the gain from pre-treatment to post-treatment for the Web ORLA® versus Control groups. However, the Web ORLA® group showed significantly greater gains at the six-week follow-up than the control group (X = 2.70; SD = 1.01; P = 0.013; ES = 1.92). Conclusion: Results provide evidence for improved language outcomes following intensive, web-based delivery of ORLA® to individuals with chronic aphasia. Findings underscore the value of combining clinician oversight with the flexibility of asynchronous practice. [ABSTRACT FROM AUTHOR]

Objective: To compare prefabricated and custom resting hand splints and establish the feasibility of splinting research for larger scale trials. Design: A Randomized controlled pilot study where the randomization unit was each hand, rather than each individual. Setting: Thirty-two-bed spinal cord injury and multi-trauma rehabilitation unit in an urban academic rehabilitation center. Subjects: Thirty-six hands from 19 individuals with cervical spinal cord injury were enrolled during their acute rehabilitation stay. Interventions: Each eligible hand was randomized to receive a custom or prefabricated resting hand splint for night use. Main measures: The Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP) was completed at both admission and discharge, and a structured interview was completed at discharge. Results: No difference existed in GRASSP outcomes or user preference between custom and prefabricated resting hand splints. Mann-Whitney tests indicated that there was no significant difference in qualitative prehension scores (U = 141, P = 0.522) nor quantitative prehension scores (U = 135, P = 0.382) between groups. Adherence to the splinting program was high (18 out of 19 participants), and no adverse effects occurred. Four themes emerged from the participant comments: the participants felt splints were helpful in their recovery; they found it challenging to direct their caregivers to help with the splints; they needed to take ownership for managing their splints; and they wished they received more education on splint rationale. Conclusion: There was no obvious difference in outcome or user preference between prefabricated and custom resting hand splints. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the feasibility of a multi-centre randomised controlled trial to compare the clinical and cost-effectiveness of early patient-directed rehabilitation versus standard rehabilitation following surgical repair of the rotator cuff of the shoulder. Design: Two-arm, multi-centre pilot and feasibility randomised controlled trial. Setting: Five National Health Service hospitals in England. Participants: Adults (n = 73) with non-traumatic rotator cuff tears scheduled for repair were recruited and randomly allocated remotely prior to surgery. Interventions: Early patient-directed rehabilitation (n = 37); advised to remove their sling as soon as able and move as symptoms allow. Standard rehabilitation (n = 36); sling immobilisation for four weeks. Measures: (1) Randomisation of 20% or more eligible patients. (2) Difference in time out of sling of 40% or more between groups. (3) Follow-up greater than 70%. Results: 73/185 (39%) potentially eligible patients were randomised. Twenty participants were withdrawn, 11 due to not receiving rotator cuff repair. The between-group difference in proportions of participants who exceeded the cut-off of 222.6 hours out of the sling was 50% (80% CI = 29%, 72%), with the early patient-directed rehabilitation group reporting greater time out of sling. 52/73 (71%) and 52/53 (98%) participants were followed-up at 12 weeks when withdrawals were included and excluded respectively. Eighteen full-thickness re-tears were reported (early patient-directed rehabilitation = 7, standard rehabilitation = 11). Five serious adverse events were reported. Conclusion: A main randomised controlled trial is feasible but would require allocation of participants following surgery to counter the issue of withdrawal due to not receiving surgery. [ABSTRACT FROM AUTHOR]

Objectives: To investigate the feasibility and acceptability of a home-based exercise program monitored using telehealth for people with Parkinson's disease. Design: Pilot randomised control trial. Setting: University physiotherapy clinic, participants' homes. Participants: Forty people with mild to moderate Parkinson's disease, mean age 72 (6.9). Intervention: In Block 1 (5 weeks) all participants completed predominantly centre-based exercise plus a self-management program. Participants were then randomised to continue the centre-based exercise (n = 20) or to a home-based program with telehealth (n = 20) for Block 2 (5 weeks). The exercises targeted balance and gait. Outcomes: The primary outcomes were the feasibility and acceptability of the intervention. Secondary outcomes were balance, gait speed and freezing of gait. Results: Adherence was high in Block 1 (93%), and Block 2 (centre-based group = 93%, home-based group = 84%). In Block 2, the physiotherapist spent 6.4 hours providing telehealth to the home-based group (mean 10 (4) minutes per participant) and 32.5 hours delivering the centre-based exercise classes (98 minutes per participant). Participants reported that exercise was helpful, they could follow the home program and they would recommend exercising at home or in a group. However, exercising at home was less satisfying and there was a mixed response to the acceptability of the self-management program. There was no difference between groups in any of the secondary outcome measures (preferred walking speed mean difference −0.04 (95% CI: −0.12 to 0.05). Conclusion: Home-based exercise monitored using telehealth for people with Parkinson's disease is feasible and acceptable. [ABSTRACT FROM AUTHOR]

Objectives: To assess the feasibility of a multi-site randomised controlled trial to evaluate the effect of functional electrical stimulation on bradykinesia in people with Parkinson's disease. Design: A two-arm assessor blinded randomised controlled trial with an 18 weeks intervention period and 4 weeks post-intervention follow-up. Setting: Two UK hospitals; a therapy outpatient department in a district general hospital and a specialist neuroscience centre. Participants: A total of 64 participants with idiopathic Parkinson's disease and slow gait <1.25 ms−1. Interventions: Functional electrical stimulation delivered to the common peroneal nerve while walking in addition to standard care compared with standard care alone. Main measures: Feasibility aims included the determination of sample size, recruitment and retention rates, acceptability of the protocol and confirmation of the primary outcome measure. The outcome measures were 10 m walking speed, Unified Parkinson's Disease Rating Scale (UPDRS), Mini Balance Evaluation Systems Test, Parkinson's Disease Questionnaire-39, EuroQol 5-dimension 5-level, New Freezing of Gait questionnaire, Falls Efficacy Score International and falls diary. Participants opinion on the study design and relevance of outcome measures were evaluated using an embedded qualitative study. Results: There was a mean difference between groups of 0.14 ms−1 (CI 0.03, 0.26) at week 18 in favour of the treatment group, which was maintained at week 22, 0.10 ms−1 (CI –0.05, 0.25). There was a mean difference in UPDRS motor examination score of –3.65 (CI –4.35, 0.54) at week 18 which was lost at week 22 –0.91 (CI –2.19, 2.26). Conclusion: The study design and intervention were feasible and supportive for a definitive trial. While both the study protocol and intervention were acceptable, recommendations for modifications are made. [ABSTRACT FROM AUTHOR]

Objectives: To determine the feasibility and safety of aerobic training with an arm crank ergometer and its effectiveness in improving functional capacity and gait in patients with recent hip fracture. Design: Randomized, controlled, assessor-blinded pilot study, with intention-to-treat analysis. Setting: Inpatients, rehabilitation department. Subjects: 40 patients with hip fracture surgically treated. Interventions: Training group performed aerobic exercise with an arm crank ergometer (15 sessions, 30 minutes/day) at an intensity of 64% to 76% of maximum heart rate, in addition to conventional inpatient rehabilitation. Main measures: Primary outcome was the feasibility (including eligibility rate, recruitment rate, number of drop-outs and adverse events, adherence). Secondary measures were the Timed Up and Go test, ability to walk independently, muscle torque of knee extensors of fractured and non-fractured leg, Functional Independence Measure. Results: Mostly due to pre-existing disability and fracture type, only 40/301 (13%) patients were eligible (age 84.6 ± 7.6 years, 75% female); all agreed to participate and 90% completed the trial, without adverse events. Adherence to aerobic exercise was good, with high attendance at sessions (93%), a strong compliance to exercise duration (95%) but lower compliance to the prescribed intensity (73%). After the program, more patients were able to walk independently in the training group (n = 18) compared to control (n = 13) (P < 0.05). Also the muscle torque of fractured leg knee extensors was higher in the training group (P < 0.05). Conclusion: Aerobic training in addition to conventional rehabilitation after a hip fracture is feasible and safe and it was effective in improving gait performance and strength of fractured leg. Trial registration: NCT04025866. [ABSTRACT FROM AUTHOR]

Objective: Assess the feasibility and acceptability of an Internet and telephone support and problem-solving intervention for stroke caregivers. Design: Randomized controlled pilot trial with four arms: four-week intervention (n = 13), eight-week intervention (n = 13), eight-week attention control (n = 13), and standard care (n = 14). Setting: Southeastern U.S. Veterans Health System. Participants: Informal caregivers of Veterans who suffered a stroke in the preceding 2.5 years were enrolled over an 18-month period. Interventions: Intervention participants received RESCUE, a support and problem-solving intervention delivered via telephone and Internet by registered nurses. Attention control participants received active listening with no advice delivered by nurses via telephone. Main Measures: Feasibility of a larger trial was assessed via recruitment and retention. Acceptability was assessed using an adapted enactment tool and qualitative interviews. Changes in caregiver depressive symptoms and burden were measured by the Center for Epidemiologic Studies Depression Scale and Zarit Burden Interview. The study was not powered for significance testing. Results: Of 340 eligible caregivers, 53 (16%) agreed to participate. Among those enrolled, 51 (96%) completed the study. Caregiver mean age was 60.3 (10.1), 49 (93%) were female and 36 (68%) were white. At baseline, 21 (39%) caregivers had high risk of depression and 18 (33%) had significant burden. Acceptability and enactment tool findings indicated positive participant responses to the intervention. Most rated the amount of sessions the "right amount". Qualitative analysis revealed the intervention was valued by and acceptable to caregivers. Conclusions: Findings indicate the RESCUE intervention is feasible and acceptable to caregivers and warrants further testing. [ABSTRACT FROM AUTHOR]

Objective: To investigate feasibility of aquatic high intensity interval training for adolescents with cerebral palsy, who can ambulate independently but may choose a mobility aid in some circumstances. Design: Pilot randomised controlled trial. Method: Following baseline assessments, participants were randomised to usual care or ten weeks of twice weekly aquatic high intensity interval training. Each class comprised 10 one-minute exercise intervals separated by one-minute rest. High intensity exercise was defined as the attainment of ⩾80% of peak heart rate measured by telemetry. Setting: Tertiary paediatric hospital. Main Measures: Primary outcomes related to the feasibility of the protocol to progress to a definitive trial. Consumer feedback was obtained. Results: Of 119 potential participants, 46 appeared eligible and 17 consented, resulting in a recruitment fraction of 37% (95% CI 23–52). Twelve completed baseline assessments and were randomised (5 males; 14 years 7 months SD 2 years 0 months). In the intervention group, of the 1190 exercise stations (across all participants and sessions), heart rate data were available for 1180 stations and high intensity exercise was achieved during 1111 stations (93%, 95% CI 92–95). All randomised participants completed the study and reported that the intervention was fun and provided friendship opportunities. There were no major adverse events or exacerbation of pain. Conclusions: Aquatic high intensity interval training in ambulant adolescents with cerebral palsy is feasible, while maintaining adherence and fidelity. Uncertainty remains on the efficacy of the intervention, highlighting the need for a large definitive trial. [ABSTRACT FROM AUTHOR]

Objective: To establish the feasibility of a randomized, placebo-controlled trial to investigate the effect of a specific immunotherapy bacterial lysate OM-89 (Uro-Vaxom®) in reducing the frequency of urinary tract infections in people with neurogenic bladder dysfunction. Design: A parallel-group, double-blind, randomized, placebo-controlled trial. Setting: Patients at home, recruited through out-patient contact, social media and patient support groups. Subjects: People with a spinal cord injury, multiple sclerosis, transverse myelitis or cauda equina syndrome who had suffered three or more clinically diagnosed urinary tract infections treated with antibiotics over the preceding 12 months. Interventions: All participants took one capsule of oral OM-89 immunotherapy (6 mg) or matching Placebo (randomisation ratio 1:1), once daily in the morning for 3 months. Main measures: The primary outcome was occurrence of a symptomatic urinary tract infection treated with an antibiotic, assessed at 3 and 6 months. Feasibility measures included recruitment, retention and practical difficulties. Results: Of 115 patients screened, 49 were recruited, one withdrew before randomization, and 23 were allocated to the control group receiving matching placebo. Six participants, all in the control group, discontinued the intervention; all participants provided full data at both follow-up times. Over 6 months, 18/25 active group patients had 55 infections, and 18/23 control group patients had 47 infections. Most research and clinical procedures were practical, and acceptable to participants. Conclusion: It is feasible to undertake a larger trial. We recommend broader inclusion criteria to increase eligibility and generalizability. [ABSTRACT FROM AUTHOR]

Objective: To investigate the effect of small needle-knife therapy in people with painful knee osteoarthritis. Design: Pilot randomised, controlled trial. Setting: Rehabilitation hospital. Subjects: In-patients with osteo-arthritis of the knee. Interventions: Either 1 to 3 small needle-knife treatments over seven days or oral Celecoxib. All patients stayed in hospital three weeks, receiving the same mobility-focused rehabilitation. Measures: Oxford Knee Score (OKS), gait speed and kinematics were recorded at baseline, at three weeks (discharge) and at three-months (OKS only). Withdrawal from the study, and adverse events associated with the small needle knife therapy were recorded. Results: 83 patients were randomized: 44 into the control group, of whom 10 were lost by three weeks and 12 at 3 months; 39 into the experimental group of whom eight were lost at three weeks and three months. The mean (SE) OKS scores at baseline were Control 35.86 (1.05), Exp 38.38 (0.99); at three weeks 26.64 (0.97) and 21.94 (1.23); and at three months 25.83 (0.91) and 20.48 (1.14) The mean (SE) gait speed at baseline was 1.07 (0.03) m/sec (Control) and 0.98 (0.03), and at three weeks was 1.14 (0.03) and 1.12 (0.03) (P < 0.05). Linear mixed model statistical analysis showed that the improvements in the experimental group were statistically significant for total OKS score at discharge and three months Conclusions: Small needle-knife therapy added to standard therapy for patients with knee osteoarthritis, was acceptable, safe and reduced pain and improved global function on the Oxford Knee Score. Further research is warranted. [ABSTRACT FROM AUTHOR]

Objective: To evaluate feasibility and acceptability of a neuropsychologically-based vocational intervention with increased follow-up support for women with multiple sclerosis. Design: Single-blinded parallel-group randomized controlled trial with 12-month follow-up. Setting: Tertiary-care multiple sclerosis center. Participants: Forty-nine employed women with multiple sclerosis meeting criteria on measures of cognitive dysfunction (Symbol Digit Modalities Test), fatigue (Fatigue Severity Scale), and/or depression (Beck Depression Inventory/Patient Health Questionnaire). Interventions: Participants received either neuropsychological testing and phone feedback regarding findings and tailored recommendations (standard-care treatment), or testing, in-person feedback, and two calls from a care-coordinator (experimental treatment). Measures: Feasibility measures included enrollment and attrition rates, and compliance to recommendations at 12-months between groups. Acceptability was evaluated by participants' report of benefit from interventions. Secondary analyses included evaluation of symptom changes (cognition, fatigue, depression) from baseline to 12-months. Results: Of 49 women meeting screening measure thresholds, 44 were randomized to treatment groups (attrition: standard-care = 8, experimental = 6), and 30 completed the study (standard-care = 14, experimental = 16). Recommendation adherence rates did not significantly differ between standard-care and experimental groups (31% vs 49%). However, 16/16 experimental participants at least partially completed given recommendations as compared to 8/14 in the standard-care group. Participants across groups (97%) reported benefit from participation. No significant differences in symptom outcomes between groups at 12-months. Conclusion: In-person feedback and care-coordinator calls were feasible and acceptable additions to a neuropsychological intervention and may serve to increase recommendation adherence. Given high drop-out rate, particularly prior to testing, future research may explore avenues to improve completion rates and maximize benefits of such interventions. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the efficacy of a newly developed evidence-based low back pain (LBP) management smartphone application. Design: A double-blinded randomized controlled trial where participants randomly assigned to either an experimental group (EG) or a control group (CG). Setting: Governmental and private institutions. Participants: About 40 office workers, aged 30 to 55 years, had pain due to non-specific LBP > 3 on Visual Analogue Scale, and with pain chronicity > 3 months. Interventions: The EG received full version of the application 'Relieve my back' included evidence-based instructions and therapeutic exercises for LBP management, whereas the CG received placebo version included instructions about nutrition. Main measures: Primary outcome measures included pain measured by Visual Analogue Scale (VAS), disability measured by Oswestry Disability Index (ODI), and quality of life measured by Short-Form Health Survey (SF-12). Results: Following six weeks of using the application, compared to CG, the EG group demonstrated significant decrease in pain intensity (−3.45 (2.21) vs −0.11 (1.66), P < 0.001), in ODI score (−11.05 (10.40) vs −0.58 (9.0), P = 0.002), and significant increase in physical component of SF-12 (12.85 (17.20) vs −4.63 (12.04), P = 0.001). Conclusion: 'Relieve my back' application might be efficacious in reducing pain and disability and improving the quality of life of office workers with non-specific LBP. [ABSTRACT FROM AUTHOR]

Objective: To determine the feasibility of recruiting to and delivering a biopsychosocial intervention for carers of stroke survivors. Design: Feasibility randomised controlled study with nested qualitative interview study. Setting: The intervention was delivered in the community in either a group or one-to-one format. Subjects: Carers and stroke survivors within one year of stroke onset. Interventions: A carer targeted intervention delivered by a research psychologist in six structured two-hour sessions or usual care control. The intervention combined education about the biological, psychological and social effects of stroke with strategies and techniques focussing on adjustment to stroke and caregiving. Stroke survivors in both groups received baseline and follow-up assessment but no intervention. Main Outcome: Recruitment rate, study attrition, fidelity of intervention delivery, acceptability and sensitivity of outcome measures used (health related quality of life, anxiety and depression and carer burden six months after randomisation). Results: Of the 257 carers approached, 41 consented. Six withdrew before randomisation. Eighteen participants were randomised to receive the intervention and 17 to usual care. Attendance at sessions was greater when treated one-to-one. Feedback interviews suggested that participants found the intervention acceptable and peer support particularly helpful in normalising their feelings. Thirty participants were assessed at follow-up with improvements from baseline on all health measures for both groups. Conclusions: Our results suggest that a biopsychosocial intervention was acceptable to carers and can be delivered in group and one-to-one formats. Timing of approach and mode of intervention delivery is critical and requires tailoring to the carers individual needs. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to evaluate the feasibility and preliminary effects of a multicomponent intervention to decrease sedentary time during and shortly after hospitalization. Design: This is a quasi-experimental pilot study comparing outcomes in patients admitted before and after the implementation of the intervention. Setting: The study was conducted in a university hospital. Subjects: Participants were adult patients undergoing elective organ transplantation or vascular surgery. Interventions: In the control phase, patients received usual care, whereas in the intervention phase, patients also received a multicomponent intervention to decrease sedentary time. The intervention comprised eight elements: paper and digital information, an exercise movie, an activity planner, a pedometer and Fitbit Flex™, a personal activity coach and an individualized digital training program. Measures: Measures of feasiblity were the self-reported use of the intervention components (yes/no) and satisfaction (low–high = 0–10). Main outcome measure was the median % of sedentary time measured by an accelerometer worn during hospitalization and 7–14 days thereafter. Results: A total of 42 controls (mean age = 59 years, 62% male) and 52 intervention patients (58 years, 52%) were included. The exercise movie, paper information and Fitbit Flex were the three most frequently used components, with highest satisfaction scores for the fitbit, paper information, exercise movie and digital training. Median sedentary time decreased from 99.6% to 95.7% and 99.3% to 91.0% between Days 1 and 6 in patients admitted in the control and intervention phases, respectively. The difference at Day 6 reached statistical significance (difference = 41 min/day, P = 0.01). No differences were seen after discharge. Conclusion: Implementing a multicomponent intervention to reduce sedentary time appeared feasible and may be effective during but not directly after hospitalization. [ABSTRACT FROM AUTHOR]

Objectives: To investigate whether people with cerebellar degeneration can perform rigorous aerobic exercise and to assess the clinical impact of training. Design: Randomized single-blinded controlled, feasibility study comparing aerobic training to no training. Setting: Home intervention, assessments conducted at an academic medical center. Subjects: Twenty individuals with cerebellar degeneration caused by a range of genetic disorders. Intervention: Aerobic training consisted of four weeks of stationary bicycle training, five times per week for 30-minute sessions. Intensity ranged from 65% to 80% of the participant's maximal heart rate determined during cardiopulmonary exercise testing. Main measures: Primary outcome measure was change in the Scale for the Assessment and Rating of Ataxia scores. Recruitment rate, adherence, drop-out, and adverse events were also determined. The treatment was considered technically feasible if participants achieved target training frequency, duration, and intensity. Results: The 20 participants mean age was 50 years (standard deviation 15.65 years) and average Scale for the Assessment and Rating of Ataxia score was 9.6 (standard deviation 3.13). Ten participants were randomized to aerobic training and 10 to no training. Seven participants in the aerobic group attained target training duration, frequency, and intensity. There was a mean reduction in ataxia severity of 2.1 points (standard deviation 1.26) with four weeks of aerobic training, whereas ataxia severity increased by 0.3 (standard deviation 0.62) in the control group over the same period. Walking speed, balance measures, and fitness also improved in individuals who performed aerobic exercise. Conclusions: Rigorous aerobic training is feasible in people with cerebellar degeneration. Improvements in ataxia, balance, and gait are promising. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effect of an integrated transitional care program on health outcomes in stroke survivors based on an original community for healthcare. Design: A pilot randomized controlled trial with blinded assessment. Randomization by statistician using computer-generated, random numbers concealed in opaque envelopes. Setting: A tertiary hospital and participants' home across Lishui, China. Subjects: A total of 98 people with acute cerebral hemorrhage or cerebral infarction, eight weeks following discharge from our hospital. Interventions: Each participant received stroke unit–based treatment including acute medical treatment, early rehabilitation and health education. Patients in the intervention group received ongoing rehabilitation at home through multidisciplinary team, while patients in the control group received secondary stroke prevention. Main measures: Short-Form Health Survey-36, Modified Barthel Index and Caregiver Strain Index at four and eight weeks, respectively, after discharged. Results: A total of 98 participants were recruited (intervention n = 49, control n = 49). Patients had an average age of 61.4 years (61.4 ± 18.3). Mean values of Physical Components Summary and Mental Components Summary, integral components of Short-Form Health Survey-36, were significantly better in the intervention group at four and eight weeks (40.2 ± 6.3 and 42.9 ± 3.7 for the former; 43.9 ± 2.6 and 46.1 ± 1.8 for the later). The same trend was observed in Modified Barthel Index (87.1 ± 9.2 and 92.5 ± 6.7 at four and eight weeks, respectively). But the significant improvement in Caregiver Strain Index was only observed at four weeks. There were significant differences between groups in these scores. Conclusion: The transitional care program has been proven to be feasible and improve health-related outcomes. [ABSTRACT FROM AUTHOR]

Objective: Pilot a definitive randomized controlled trial of speech-language telerehabilitation in poststroke aphasia in addition to usual care with regard to recruitment, drop-outs, and language effects. Design: Pilot single-blinded randomized controlled trial. Setting: Telerehabilitation delivered from tertiary rehabilitation center to participants at their home or admitted to secondary rehabilitation centers. Subjects: People with naming impairment due to aphasia following stroke. Intervention: Sixty-two participants randomly allocated to 5 hours of speech and language telerehabilitation by videoconference per week over four consecutive weeks together with usual care or usual care alone. The telerehabilitation targeted functional, expressive language. Main measures: Norwegian Basic Aphasia Assessment: naming (primary outcome), repetition, and auditory comprehension subtests; Verb and Sentence Test sentence production subtest and the Communicative Effectiveness Index at baseline, four weeks, and four months postrandomization. Data were analyzed by intention to treat. Results: No significant between-group differences were seen in naming or auditory comprehension in the Norwegian Basic Aphasia Assessment at four weeks and four months post randomization. The telerehabilitation group (n = 29) achieved a Norwegian Basic Aphasia Assessment repetition score of 8.9 points higher (P = 0.026) and a Verb and Sentence Test score 3 points higher (P = 0.002) than the control group (n = 27) four months postrandomization. Communicative Effectiveness Index was not significantly different between groups, but increased significantly within both groups. No adverse events were reported. Conclusion: Augmented telerehabilitation via videoconference may be a viable rehabilitation model for aphasia affecting language outcomes poststroke. A definitive trial with 230 participants is needed to confirm results. [ABSTRACT FROM AUTHOR]

Objectives: The main objective of this study is to determine the feasibility of recruiting and retaining patients recently diagnosed with thoracic cancer to a trial of short-term integrated rehabilitation; evaluate uptake of theoretically informed components targeting physical function, symptom self-management and participation; estimate sample size requirements for an efficacy trial. Design: Parallel group randomized controlled feasibility trial. Setting: Three U.K. hospitals. Participants: Patients ⩽eight weeks of thoracic cancer diagnosis, Eastern Cooperative Oncology Group Performance Status 0–3, any cancer stage and treatment plan. Interventions: Participants randomly allocated (1:1) to short-term integrated rehabilitation and standard care or standard care alone over 30 days. Main measures: Primary: participant recruitment and retention, targeting ⩾30% of eligible patients enrolling and ⩾50% of participants reporting outcomes at 30 days. Secondary: intervention fidelity; missing data and performance of outcome measures for self-efficacy, symptoms, physical activity and health-related quality of life. Results: Of 159 eligible patients approached, 54 (34%) were recruited. A total of 44 (82%) and 39 (72%) participants reported outcomes at 30 and 60 days, respectively. Intervention fidelity was high. Rehabilitation was delivered across 3 (1–3) sessions over 32 (22–45) days (median (range)). Changes in clinical outcomes were modest but most apparent at 60 days for health-related quality of life: Functional Assessment of Cancer Therapy Lung Cancer score median (interquartile range) change 9.7 (−12.0 to 16.0) rehabilitation versus 2.3 (−15.0 to 14.5) standard care. Conclusion: A trial to examine efficacy of short-term integrated rehabilitation for people newly diagnosed with thoracic cancer is feasible. A sample of 336 participants could detect a meaningful effect on health-related quality of life as the primary outcome. [ABSTRACT FROM AUTHOR]

Objective: To evaluate feasibility and potential effectiveness of work-directed rehabilitation in people with common mental disorders. Design: Pilot randomized controlled trial. Setting: Primary healthcare, Sweden. Subjects: Working adults (n = 42) of mean age 46.2 ± 11.1 years with depression or anxiety disorder. Interventions: Eight weeks of work-directed rehabilitation (n = 21) or physical activity (n = 21). Work-directed rehabilitation included sessions with a physiotherapist and/or an occupational therapist, to develop strategies to cope better at work. Physical activity included a planning session and access to a local gym. Main measures: Feasibility: attendance, discontinuation and adverse events. Measurements were the Work Ability Index, the Global Assessment of Functioning, the Montgomery–Asberg Depression Rating Scale, the Beck Anxiety Inventory and the World Health Organization—Five Well-Being Index. Results: Attendance to rehabilitation sessions was 88% (n = 147/167) and discontinuation rate was 14% (n = 3/21). No serious adverse events were reported. Within both groups, there was a significant improvement in Work Ability Index score (mean change: 3.6 (95% confidence interval (CI): 0.45, 6.7) in work-directed rehabilitation and 3.9 (95% CI: 0.9, 7.0) in physical activity) with no significant difference between groups. For the other outcomes, significant improvements were found within but not between groups. Per-protocol analysis showed a trend toward the antidepressant effect of work-directed rehabilitation compared to physical activity (mean difference in depression score −3.1 (95% CI: −6.8, 0.4), P = 0.075). Conclusion: Work-directed rehabilitation was feasible to persons with common mental disorders and improved their work ability and mental health. Comparable improvements were seen in the physical activity group. Suggested modifications for a larger trial include adding a treatment-as-usual control. [ABSTRACT FROM AUTHOR]

Objective: To establish feasibility of initiating electrical stimulation treatment of wrist extensors and flexors in patients early after stroke to prevent muscle contractures and pain. Design: Feasibility randomized controlled trial with economic evaluation. Setting: A specialist stroke unit in Nottinghamshire. Subjects: A total of 40 patients recruited within 72 hours post-stroke with arm hemiparesis. Interventions: Participants were randomized to receive usual care or usual care and electrical stimulation to wrist flexors and extensors for 30 minutes, twice a day, five days a week for three months. Initial treatment was delivered by an occupational therapist or physiotherapist who trained participants to self-manage subsequent treatments. Measures: Measures of feasibility included recruitment and attrition rates, completion of treatment, and successful data collection. Outcome data on wrist range of motion, pain, arm function, independence, quality of life, and resource use were measured at 3-, 6-, and 12-months post-randomization. Results: A total of 40 participants (of 215 potentially eligible) were recruited in 15 months (20 men; mean age: 72 (SD: 13.0)). Half the participants lacked mental capacity and were recruited by consultee consent. Attrition at three-month follow-up was 12.5% (death (n = 2), end-of-life care (n = 2), and unable to contact (n = 1)). Compliance varied (mean: 65 (SD: 53)) and ranged from 10 to 166 treatments per patient (target dosage was 120). Data for a valid economic analysis can be adequately collected. Conclusion: Early initiation of electrical stimulation was acceptable and feasible. Data collection methods used were feasible and acceptable to participants. A large definitive study is needed to determine if electrical stimulation is efficacious and cost effective. [ABSTRACT FROM AUTHOR]

Objective: To investigate the effect of gradual attention training on language function with aphasia. Design: Randomized controlled trial. Participants: A total of 40 patients (mean age: 53.47 years) with post-stroke aphasia came from the stroke rehabilitation unit of rehabilitation department in the First Hospital of Jilin University, of which 13 (32.5%) had intracerebral hemorrhage, 28 inpatients and 12 outpatients, 11 women and 29 men, 34 within three-month stroke and 6 within three months to one year. Interventions: All participants were divided into control and experimental groups. Both groups received language treatment 20 minutes a day, six days/week, for five weeks, and the experimental group received gradual attention training 20 minutes a day, six days/week, for five weeks. Main measures: Language function was assessed pre- and post-treatment by components of the Western Aphasia Battery (WAB) which included spontaneous speech, auditory comprehension, repetition, and naming and then calculated the aphasia quotient (AQ). Results: The mean (SD) AQ of the experimental group and control group, respectively, was 25.71 (12.63) and 26.2 (12.31) at baseline. After treatment, the AQ mean (SD) was 43.08 (15.14) in the experimental group, which showed a significant improvement compared to 33.48 (14.04) in the control group (P = 0.02).All items of WAB were higher in experimental group than those in control group, especially in auditory comprehension and naming (P = 0.02, 0.01). Conclusion: Gradual attention training seemed to improve language function in post-stroke aphasia, specifically function of listening comprehension and naming. [ABSTRACT FROM AUTHOR]

Objective: We investigated adding lower limb transcutaneous nerve stimulation or neuromuscular electrical stimulation to standard early rehabilitation in acute stroke patients. Design: An assessor-blinded, randomized controlled pilot study. Setting: A medical stroke center. Subjects: First-stroke patients aged 20–80 years admitted to the stroke center within 24 hours post stroke. Interventions: A total of 42 participants were randomly assigned to groups: transcutaneous nerve stimulation + standard early rehabilitation, neuromuscular electrical stimulation + standard early rehabilitation, or standard early rehabilitation-only. Transcutaneous nerve or neuromuscular electrical stimulation was delivered to the affected tibialis anterior and quadriceps muscles for 30 minutes a day, five days per week for two weeks. Main measures: The Postural Assessment Scale for Stroke Patients, the Functional Independence Measure, and three mobility milestones, namely, sitting for >five minutes, standing for >one minute, and walking ⩾50 m, were evaluated, respectively, at baseline, at the two-week post-intervention, and at two-week follow-up. Results: Significant differences existed in the Postural Assessment Scale for Stroke Patients scores between the transcutaneous nerve stimulation and standard early rehabilitation-only groups measured at two-weeks post-intervention (mean (SD) = 31.38 (5.39) and 18.00 (8.65), respectively) and at the two-week follow-up (34.08 (2.69) and 26.14 (7.77), respectively). A higher proportion of participants could walk ⩾50 m independently in the transcutaneous nerve stimulation group than in the standard early rehabilitation-only group at the two-week post-intervention (P = 0.013) and two-week follow-up (P = 0.01) marks. Conclusion: Two weeks of transcutaneous nerve stimulation added to standard early rehabilitation improved postural stability and walking in acute stroke patients. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to explore the feasibility of conducting a randomized controlled trial of dynamic Lycra® orthoses as an adjunct to arm rehabilitation after stroke and to explore the magnitude and direction of change on arm outcomes. Design: This is a single-blind, two-arm parallel group, feasibility randomized controlled trial. Setting: In-patient rehabilitation. Subjects: The study participants were stroke survivors with arm hemiparesis two to four weeks after stroke receiving in-patient rehabilitation. Interventions: Participants were randomized 2:1 to wear Lycra® gauntlets for eight hours daily for eight weeks, plus usual rehabilitation (n = 27), or to usual rehabilitation only (n = 16). Main measures: Recruitment, retention, fidelity, adverse events and completeness of data collection were examined at 8 and 16 weeks; arm function (activity limitation; Action Research Arm Test, Motor Activity Log) and impairment (Nine-hole Peg Test, Motricity Index, Modified Tardieu Scale). Structured interviews explored acceptability. Results: Of the target of 51, 43 (84%) participants were recruited. Retention at 8 weeks was 32 (79%) and 24 (56%) at 16 weeks. In total, 11 (52%) intervention group participants and 6 (50%) control group participants (odds ratio = 1.3, 95% confidence interval = 0.2 to 7.8) had improved Action Research Arm Test level by 8 weeks; at 16 weeks, this was 8 (61%) intervention and 6 (75.0%) control participants (odds ratio = 1.1, 95% confidence interval = 0.1 to 13.1). Change on other measures favoured control participants. Acceptability was influenced by 26 adverse reactions. Conclusion: Recruitment and retention were low, and adverse reactions were problematic. There were no indications of clinically relevant effects, but the small sample means definitive conclusions cannot be made. A definitive trial is not warranted without orthoses adaptation. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the feasibility of a multicentre, observer-blind, pilot randomized controlled trial (RCT) of a wristband accelerometer with activity-dependent vibration alerts to prompt impaired arm use after stroke. Design: Parallel-group pilot RCT. Setting: Four English stroke services. Participants: Patients 0–3 months post stroke with a new arm deficit. Intervention: Participants were randomized to wear a prompting or 'sham' wristband during a four-week self-directed therapy programme with twice-weekly therapy review. Main outcomes: Recruitment, retention and adherence rates, safety and completion of assessments were reported. Arm recovery was measured by Action Research Arm Test (ARAT) and Motor Activity Log (MAL) without statistical comparison. Results: In total, 33 patients were recruited (0.6 per month/site; median time post stroke: 26 days (interquartile range (IQR):15.5–45)). Baseline, four-week and eight-week median (IQR) ARAT for the control group (n = 19) were 15 (2–35), 35 (15–26) and 31 (21–55) and those for the intervention group (n = 14) were 37 (16–45), 57 (29–57) and 57 (37–57), respectively; for MAL Amount of Use, the corresponding values in the control group were 0.2 (0.0–1.2), 1.1 (0.3–2.9) and 1.2 (0.7–2.9) and in the intervention group were 1.4 (0.5–2.6), 3.8 (1.9–4.5) and 3.7 (2.1–4.3). Four participants withdrew from the study. Wristbands were worn for 79% of the recommended time. The intervention and control group participants received a median of 6.0 (IQR: 4.3–8.0) and 7.5 (IQR: 6.8–8.0) therapy reviews. A median of 8 (IQR: 6–10) prompts were delivered per intervention participant/day. Research assessments were completed for 28/29 and 25/28 patients at four and eight weeks. Eight serious adverse events were reported, all unrelated to the intervention. Conclusion: A multicentre RCT of wristband accelerometers to prompt arm activity early after stroke is feasible. A total sample of 108 participants would be required. [ABSTRACT FROM AUTHOR]

Objective: To investigate the reliability, time efficiency and clinical feasibility of five commonly used methods for assessing excessive arm volume in patients with breast cancer–related lymphoedema (BCRL). Design: Cross-sectional study. Setting: University Hospitals Leuven, Belgium. Subjects: 30 participants with unilateral BCRL. Methods: Excessive arm volume was determined by five different methods: traditional volumetry with overflow, volumetry without overflow, inverse volumetry, optoelectronic volumetry and calculated volume based on circumference measurements. To investigate intra- and inter-rater reliability, measurements were performed twice by the same assessor and once by a different assessor. Intraclass correlation coefficients (ICCs), standard errors of the measurement (SEMs) and systematic changes between the means were calculated. To determine time efficiency, the mean setup time, execution time and total time were examined for each method. Furthermore, 12 limitations regarding clinical feasibility were listed and scored for each method. Finally, an overall ranking score was determined between the methods. Results: Mean age was 65 (±8) years and mean body mass index was 28 (±4) kg/m2. Intra- and inter-rater reliability ranged between strong and very strong. Calculated arm volume based on circumferences (mean excessive arm volume: assessor A: 477 (±367) mL; assessor B: 470 (±367) mL; assessor A (second time): 493 (±362) mL) showed the highest intra- and inter-rater ICCs of.987 and.984, respectively. Optoelectronic volumetry was the fastest method, representing a mean total time of 1 minute and 43 (±26) seconds for performing a bilateral measurement. The least limitations were reported on the calculated volume based on the circumference method (3 out of 12 limitations). Conclusion: Calculated volume based on arm circumferences is the best measurement method for evaluating excessive arm volume over time in terms of reliability, low error rate, low cost, few limitations and the time spent. [ABSTRACT FROM AUTHOR]