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Background: Upper limb activity following stroke is low, which may limit recovery. We investigated whether a virtually-delivered upper limb program, that included a wearable device with reach-to-grasp feedback, would increase upper limb activity after stroke., Methods: This was a parallel-group, assessor-blinded, randomized control trial conducted at 6 sites across 5 provinces of the CanStroke Recovery Trials Platform between 2020 to 2022. Participants (n = 73) were community-living, less than 1 year post stroke, and had residual arm movement and upper limb use limitations. Participants were randomized via a central web-based randomization service to receive a virtually delivered program (Virtual Arm Boot Camp [V-ABC], n = 36) or waitlist control (n = 37) receiving usual care. V-ABC consisted of a home exercise program, feedback from a wrist-worn device to monitor reach-to-grasp counts, and 6 virtual sessions with a trained therapist over 3 weeks. The primary outcome was the average daily reach-to-grasp counts over 3 days at 4 weeks post baseline assessment. Secondary outcomes included upper limb function, self-reported use, and quality of life. Within-subject changes between pre, post treatment, and 2 months follow up for all participants were also examined as a tertiary analysis., Results: The V-ABC group demonstrated greater average daily reach-to-grasp counts (primary outcome) at 4 weeks compared to control (mean difference = 368, 95% confidence interval = 6-730, P  = .046)., Conclusions: This study provided evidence that a virtually delivered upper limb program that consists of exercise, feedback from a wearable device, and therapist support can increase real-world upper limb activity following stroke., Clinical Trial Registration: NCT04232163., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Dr. Menon has a vested interest in commercializing the technology and may benefit financially from its potential commercialization through BioInteractive Technologies. The other authors declare that they have no competing interests.

Control comparator selection is a critical trial design issue. Preclinical and clinical investigators who are doing trials of stroke recovery and rehabilitation interventions must carefully consider the appropriateness and relevance of their chosen control comparator as the benefit of an experimental intervention is established relative to a comparator. Establishing a strong rationale for a selected comparator improves the integrity of the trial and validity of its findings. This Stroke Recovery and Rehabilitation Roundtable (SRRR) taskforce used a graph theory voting system to rank the importance and ease of addressing challenges during control comparator design. "Identifying appropriate type of control" was ranked easy to address and very important, "variability in usual care" was ranked hard to address and of low importance, and "understanding the content of the control and how it differs from the experimental intervention" was ranked very important but not easy to address. The CONtrol DeSIGN (CONSIGN) decision support tool was developed to address the identified challenges and enhance comparator selection, description, and reporting. CONSIGN is a web-based tool inclusive of seven steps that guide the user through control comparator design. The tool was refined through multiple rounds of pilot testing that included more than 130 people working in neurorehabilitation research. Four hypothetical exemplar trials, which span preclinical, mood, aphasia, and motor recovery, demonstrate how the tool can be applied in practice. Six consensus recommendations are defined that span research domains, professional disciplines, and international borders., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

While many areas of medicine have benefited from the development of objective assessment tools and biomarkers, there have been comparatively few improvements in techniques used to assess brain function and dysfunction. Brain functions such as perception, cognition, and motor control are commonly measured using criteria-based, ordinal scales which can be coarse, have floor/ceiling effects, and often lack the precision to detect change. There is growing recognition that kinematic and kinetic-based measures are needed to quantify impairments following neurological injury such as stroke, in particular for clinical research and clinical trials. This paper will first consider the challenges with using criteria-based ordinal scales to quantify impairment and recovery. We then describe how kinematic-based measures can overcome many of these challenges and highlight a statistical approach to quantify kinematic measures of behavior based on performance of neurologically healthy individuals. We illustrate this approach with a visually-guided reaching task to highlight measures of impairment for individuals following stroke. Finally, there has been considerable controversy about the calculation of motor recovery following stroke. Here, we highlight how our statistical-based approach can provide an effective estimate of impairment and recovery.

Rationale: Clinical practice guidelines support structured, progressive protocols for improving walking after stroke. Yet, practice is slow to change, evidenced by the little amount of walking activity in stroke rehabilitation units. Our recent study (n = 75) found that a structured, progressive protocol integrated with typical daily physical therapy improved walking and quality-of-life measures over usual care. Research therapists progressed the intensity of exercise by using heart rate and step counters worn by the participants with stroke during therapy. To have the greatest impact, our next step is to undertake an implementation trial to change practice across stroke units where we enable the entire unit to use the protocol as part of standard of care., Aims: What is the effect of introducing structured, progressive exercise (termed the Walk 'n Watch protocol) to the standard of care on the primary outcome of walking in adult participants with stroke over the hospital inpatient rehabilitation period? Secondary outcomes will be evaluated and include quality of life., Methods and Sample Size Estimates: This national, multisite clinical trial will randomize 12 sites using a stepped-wedge design where each site will be randomized to deliver Usual Care initially for 4, 8, 12, or 16 months (three sites for each duration). Then, each site will switch to the Walk 'n Watch phase for the remaining duration of a total 20-month enrolment period. Each participant will be exposed to either Usual Care or Walk 'n Watch. The trial will enroll a total of 195 participants with stroke to achieve a power of 80% with a Type I error rate of 5%, allowing for 20% dropout. Participants will be medically stable adults post-stroke and able to take five steps with a maximum physical assistance from one therapist. The Walk 'n Watch protocol focuses on completing a minimum of 30 min of weight-bearing, walking-related activities (at the physical therapists' discretion) that progressively increase in intensity informed by activity trackers measuring heart rate and step number., Study Outcome(s): The primary outcome will be the change in walking endurance, measured by the 6-Minute Walk Test, from baseline (T1) to 4 weeks (T2). This change will be compared across Usual Care and Walk 'n Watch phases using a linear mixed-effects model. Additional physical, cognitive, and quality of life outcomes will be measured at T1, T2, and 12 months post-stroke (T3) by a blinded assessor., Discussion: The implementation of stepped-wedge cluster-randomized trial enables the protocol to be tested under real-world conditions, involving all clinicians on the unit. It will result in all sites and all clinicians on the unit to gain expertise in protocol delivery. Hence, a deliberate outcome of the trial is facilitating changes in best practice to improve outcomes for participants with stroke in the trial and for the many participants with stroke admitted after the trial ends.

Background: Numerous studies have found associations when change scores are regressed onto initial impairments in people with stroke (slopes ≈ 0.7). However, there are important statistical considerations that limit the conclusions we can draw about recovery from these studies., Objective: To provide an accessible checklist of conceptual and analytical issues on longitudinal measures of stroke recovery. Proportional recovery is an illustrative example, but these considerations apply broadly to studies of change over time., Methods: Using a pooled data set of n = 373 Fugl-Meyer Assessment upper extremity scores, we ran simulations to illustrate 3 considerations: (1) how change scores can be problematic in this context; (2) how "nil" and nonzero null-hypothesis significance tests can be used; and (3) how scale boundaries can create the illusion of proportionality, whereas other analytical procedures (eg, post hoc classifications) can augment this problem., Results: Our simulations highlight several limitations of common methods for analyzing recovery. We find that uniform recovery leads to similar group-level statistics (regression slopes) and individual-level classifications (into fitters and nonfitters) that have been claimed as evidence for the proportional recovery rule. New analyses, however, also speak to the complexities in variance about the regression slope., Conclusions: Our results highlight that one cannot identify whether proportional recovery is true or not based on commonly used methods. We illustrate how these techniques, measurement tools, and post hoc classifications (eg, nonfitters) can create spurious results. Going forward, the field needs to carefully consider the influence of these factors on how we measure, analyze, and conceptualize recovery.

Background and Purpose: The modified Rankin Scale (mRS) is the most widely used primary outcome measure in acute stroke trials. However, substantial interobserver variability impairs outcome assessment as well as reduces power of clinical trials. Guided by the International Classification of Functioning, Disability and Health, we developed a comprehensive, hierarchical assessment tool (miFUNCTION) to address the shortcomings of the modified Rankin Scale and deliver a more thorough understanding of disability following stroke., Methods: The initial construct validity of miFUNCTION was established in a pilot study of patients at an outpatient stroke prevention clinic that had been diagnosed with stroke within 60 days. To further assess criterion validity, miFUNCTION was compared against the modified Rankin Scale and other outcome measures within the Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion With Emphasis on Minimizing CT to Recanalization Times (ESCAPE) trial. Logistic regression analysis with miFUNCTION as an outcome was used to demonstrate the beneficial effect of endovascular treatment., Results: The pilot study showed moderate inter-observer agreement (k = 0.585, p < 0.005) but near perfect correlation between miFUNCTION and modified Rankin Scale (ρ = 0.821, p < 0.05). The correlation of miFUNCTION and modified Rankin Scale was near perfect again in the ESCAPE trial (ρ = 0.944). Effect size of the multivariable models using modified Rankin Scale (adjusted odds ratio: 3.45, 95% confidence interval: 2.05-5.78) and miFUNCTION (adjusted odds ratio: 3.32, 95% confidence interval: 1.99-5.55) as an outcome measure for the ESCAPE trial patients was similar., Conclusions: miFUNCTION is strongly associated with the degree of disability following stroke both in an outpatient setting and a clinical trial. Further work remains to assess sensitivity to change and to improve the inter-observer reliability of the scale.

Rationale: A top priority in stroke rehabilitation research is determining the appropriate exercise dose to optimize recovery. Although more intensive rehabilitation very early after stroke may be deleterious to recovery, inpatient rehabilitation, occurring after acute care, may be a more appropriate setting to assess therapeutic dose on neurological recovery., Hypothesis: Individuals receiving higher intensity and dose exercise programs will yield greater improvements in walking ability over usual inpatient physical therapy care., Methods and Design: Seventy-five individuals across seven inpatient rehabilitation sites in Canada will be randomized into one of three treatment programs, each 5 days/week, for four weeks and monitored for exertion (heart rate) and repetitions (step count)., Study Outcomes: The primary outcome measure is the 6 min walk and secondary outcomes include functional independence, cognitive, and quality-of-life measures. Outcome data will be assessed at four time points., Summary: This trial will contribute to our knowledge of the therapeutic intensity and dose necessary to maximize functional recovery at a very important stage of rehabilitation and neural recovery poststroke.

Two decades of research on robots and upper extremity rehabilitation has resulted in recommendations from systematic reviews and guidelines on their use in stroke. Robotics are often cited for their ability to encourage mass practice as a means to enhance recovery of movement. Yet, stroke recovery is a complex process occurring across many aspects of neurologic function beyond movement. As newer devices are developed and enhanced assessments are integrated into treatment protocols, the potential of robotics to advance rehabilitation will continue to grow.

Background: After stroke, visuospatial and kinesthetic (sense of limb motion) deficits are common, occurring in approximately 30% and 60% of individuals, respectively. Although both types of deficits affect aspects of spatial processing necessary for daily function, few studies have investigated the relationship between these 2 deficits after stroke., Objective: We aimed to characterize the relationship between visuospatial and kinesthetic deficits after stroke using the Behavioral Inattention Test (BIT) and a robotic measure of kinesthetic function., Methods: Visuospatial attention (using the BIT) and kinesthesia (using robotics) were measured in 158 individuals an average of 18 days after stroke. In the kinesthetic matching task, the robot moved the participant's stroke-affected arm at a preset direction, speed, and magnitude. Participants mirror-matched the robotic movement with the less/unaffected arm as soon as they felt movement in their stroke affected arm., Results: We found that participants with visuospatial inattention (neglect) had impaired kinesthesia 100% of the time, whereas only 59% of participants without neglect were impaired. For those without neglect, we observed that a higher percentage of participants with lower but passing BIT scores displayed impaired kinesthetic behavior (78%) compared with those participants who scored perfect or nearly perfect on the BIT (49%)., Conclusions: The presence of visuospatial neglect after stroke is highly predictive of the presence of kinesthetic deficits. However, the presence of kinesthetic deficits does not necessarily always indicate the presence of visuospatial neglect. Our findings highlight the importance of assessment and treatment of kinesthetic deficits after stroke, especially in patients with visuospatial neglect., (© The Author(s) 2014.)

Objective: Using robotic technology, we examined the ability of a visually guided reaching task to assess the sensorimotor function of patients with stroke., Methods: Ninety-one healthy participants and 52 with subacute stroke of mild to moderate severity (26 with left- and 26 with right-affected body sides) performed an unassisted reaching task using the KINARM robot. Each participant was assessed using 12 movement parameters that were grouped into 5 attributes of sensorimotor control., Results: A number of movement parameters individually identified a large number of stroke participants as being different from 95% of the controls-most notably initial direction error, which identified 81% of left-affected patients. We also found interlimb differences in performance between the arms of those with stroke compared with controls. For example, whereas only 31% of left-affected participants showed differences in reaction time with their affected arm, 54% showed abnormal interlimb differences in reaction time. Good interrater reliability (r > 0.7) was observed for 9 of the 12 movement parameters. Finally, many stroke patients deemed impaired on the reaching task had been scored 6 or less on the arm portion of the Chedoke-McMaster Stroke Assessment Scale, but some who scored a normal 7 were also deemed impaired in reaching., Conclusions: Robotic technology using a visually guided reaching task can provide reliable information with greater sensitivity about a patient's sensorimotor impairments following stroke than a standard clinical assessment scale.

Background: Impairment of position sense of the upper extremity (UE) may impede activities of daily living and limit motor gains after stroke. Most clinical assessments of position sense rely on categorical or ordinal ratings by clinicians that lack sensitivity to change or the ability to discriminate subtle deficits., Objective: Use robotic technology to develop a reliable, quantitative technique with a continuous scale to assess UE position sense following stroke., Methods: Forty-five patients recruited from an inpatient stroke rehabilitation service and 65 age-matched healthy controls performed an arm position matching task. Each UE was fitted in the exoskeleton of a KINARM device. One UE was passively placed in one of 9 positions, and the subject was told to match his or her position with the other UE. Patients were compared with statistical distributions of control data to identify those with deficits in UE position sense. Test-retest sessions using 2 raters established interrater reliability., Results: Two thirds of left hemiparetic and one third of right hemiparetic patients had deficits in limb position sense. Left-affected stroke subjects demonstrated significantly more trial-to-trial variability than right-affected or control subjects. The robotic assessment technique demonstrated good interrater reliability but limited agreement with the clinical thumb localizing test., Conclusions: Robotic technology can provide a reliable quantitative means to assess deficits in limb position sense following stroke.