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Background. Cortical stimulation (CS) combined with rehabilitation may improve upper limb motor function after stroke. Objective. Describe the study design for the Everest Clinical Trial, a randomized single-blinded pivotal device trial, testing safety and efficacy of epidural CS delivered during rehabilitation for upper limb motor function in patients with ischemic stroke. Method . A total of 174 participants from 21 centers with hemiplegia at least 4 months after acute ischemic stroke are randomized in a 2:1 ratio to investigational or control groups. Investigational patients undergo implantation of cortical electrode and pulse generator and receive 6 weeks of upper limb rehabilitation with subthreshold CS delivered only during therapy. Control group patients receive the same therapy without device implantation or stimulation. Primary outcome measures include the upper extremity Fugl-Meyer (UEFM) score and the arm motor ability test (AMAT) measured at baseline and 1, 4, 12, and 24 weeks following rehabilitation treatment with primary endpoint at 4 weeks following treatment. A successful outcome is defined as an improvement in UEFM of at least 4.5 points and in AMAT of at least 0.21 points from baseline to primary endpoint. A 20% better success rate between investigational and control groups will be considered clinically meaningful. Adverse events occurring during the study will be identified. Results. Not applicable. Conclusions . The Everest Clinical Trial is the first randomized pivotal trial on the safety and efficacy of direct CS delivered during rehabilitation for recovery of upper limb motor function in patients with ischemic stroke. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the feasibility of a fully implanted cortical stimulator for improving hand and arm function in patients following ischemic stroke. Method: Twenty-four chronic stroke patients with hemiplegia were randomized to targeted implanted cortical electrical stimulation of the motor cortex with upper limb rehabilitation therapy or rehabilitation therapy alone. Results: Using repeated measures regression models, we estimated and compared treatment effects between groups over the study follow-up period. The investigational group had significantly greater mean improvements in Upper Extremity Fugl-Meyer (UEFM) scores during the 6-month follow-up period (weeks 1-24 following therapy), as compared to the control group (difference in estimated means = 3.8, p = .042). Box and Block (B & B) test improvement from baseline scores were also significantly better in the investigational group across the 6-month follow-up assessments (difference in estimated means = 3.8, p = .046). There was one report of seizure after device implant but prior to cortical stimulation and rehabilitation therapy, but no reports of neurologic decline. There were no improvements seen in the other measures assessed. Conclusion: Evidence suggests that cortical stimulation with rehabilitation therapy produces a lasting treatment effect in upper extremity motor control and is not associated with serious neurological complications. A larger multicenter study is underway. [ABSTRACT FROM AUTHOR]

Background: To determine if low-frequency repetitive transcranial magnetic stimulation targeting the primary motor cortex contralateral (M1 CL ) to the affected corticospinal tract in patients with hemiparetic stroke augments intensive training-related clinical improvement; an extension of the NICHE trial (Navigated Inhibitory rTMS to Contralesional Hemisphere Trial) using an alternative sham coil., Methods: The present E-FIT trial (Electric Field Navigated 1Hz rTMS for Post-stroke Motor Recovery Trial) included 5 of 12 NICHE trial outpatient US rehabilitation centers. The stimulation protocol remained identical (1 Hz repetitive transcranial magnetic stimulation, M1 CL , preceding 60-minute therapy, 18 sessions/6 wks; parallel arm randomized clinical trial). The sham coil appearance mimicked the active coil but without the weak electric field in the NICHE trial sham coil. Outcomes measured 1 week, and 1, 3, and 6 months after the end of treatment included the following: upper extremity Fugl-Meyer (primary, 6 months after end of treatment), Action Research Arm Test, National Institutes of Health Stroke Scale, quality of life (EQ-5D), and safety., Results: Of 60 participants randomized, 58 completed treatment and were included for analysis. Bayesian analysis of combined data from the E-FIT and the NICHE trials indicated that active treatment was not superior to sham at the primary end point (posterior mean odds ratio of 1.94 [96% credible interval of 0.61-4.80]). For the E-FIT intent-to-treat population, upper extremity Fugl-Meyer improvement ≥5 pts occurred in 60% (18/30) active group and 50% (14/28) sham group. Participants enrolled 3 to 6 months following stroke had a 67% (31%-91% CI) response rate in the active group at the 6-month end point versus 50% in the sham group (21.5%-78.5% CI). There were significant improvements from baseline to 6 months for both active and sham groups in upper extremity Fugl-Meyer, Action Research Arm Test, and EQ-5D ( P <0.05). Improvement in National Institutes of Health Stroke Scale was observed only in the active group ( P =0.004). Ten serious unrelated adverse events occurred (4 active group, 6 sham group, P =0.72)., Conclusions: Intensive motor rehabilitation 3 to 12 months after stroke improved clinical impairment, function, and quality of life; however, 1 Hz-repetitive transcranial magnetic stimulation was not an effective treatment adjuvant in the present sample population with mixed lesion location and extent., Registration: URL: https://www., Clinicaltrials: gov; Unique identifier: NCT03010462., Competing Interests: Disclosures Dr Laine is employed and reports stock holdings in Nexstim Corporation. Dr Fregni reports compensation from Neurive for consultant services and research funding from National Institutes of Health. Dr Rogers reports grants from Nexstim. Dr Harvey reports compensation from Neuro-Innovators LLC for consultant services.

Introduction: The Motricity Index (MI) can predict motor function after rehabilitation, but its minimal clinically important difference (MCID) has not been established. The primary study aim was to estimate the MCID value of the MI arm score., Methods: Between 2017 and 2018, 173 participants hospitalized with confirmed ischemic stroke were recruited into an observational rehabilitation study. Participants with motor weakness as measured by the Fugl-Meyer upper-extremity (FM-UE) and MI with complete baseline and follow-up assessments at 3 months were included in this analysis. The longitudinal recovery of the MI arm score was anchored to having a poor outcome based on the FM-UE recovery (<9) longitudinally. Results reported include the area-under-curve (AUC), along with sensitivity, specificity, and optimal cut-points based on maximizing the Youden statistic., Results: Sixty-nine patients (median [IQR] age 70 [18] years; 48% male; 54% white) were included in the final analysis. Mean ± standard deviation outcome scores at 3-months were: MI arm: 83.19 ± 22.80; FM-UE: 53.04 ± 17.26. For the primary results, the MI arm score optimal MCID cutoff for observed recovery was 13 points with a sensitivity of 80% (95% Confidence Interval (CI)(67.6%, 92.4%)) and a specificity of 69.0% (95% CI (52.1, 85.8%)), and the AUC was 0.8082 (0.7007, 0.9157)., Conclusions: This was the first study to report the MCID of the MI arm score, as anchored to the FM-UE recovery between acute evaluation and 3-months. The estimated optimal MCID of improvement in the MI arm score was 13 points.

Locked-in syndrome is a rare and devastating condition that results in tetraplegia, lower cranial nerve paralysis, and anarthria with preserved cognition, vertical gaze, and upper eyelid movements. Although acute management is much like that of any severe stroke, rehabilitation and recovery of these patients have not been previously described. Challenges relevant to this population include blood pressure management and orthostasis, timing and appropriateness of reinstating oral feeding, ventilatory support, decannulation after tracheostomy, bowel and bladder management, vestibular dysfunction, and eye care. Targeted rehabilitation of head, neck, and trunk stability to improve function, and proper fit in an appropriate wheelchair are essential to assist with mobility. Rehabilitation interventions should include a focus on distal motor control and upright tolerance training followed by balance and mobility exercises. In addition, special considerations must be given to developing early methods of communication through use of augmentative systems to call for help and express needs. These systems along with additional technology provide the basis to promote connectivity to family and friends through the use of social media and the internet. Establishment of communication, mobility, and connectivity is essential in promoting independence, autonomy, and improving quality of life. Overall, with specialized rehabilitative care and access to the proper equipment, long-term outcomes and quality of life in these patients can be favorable., (© 2021 American Academy of Physical Medicine and Rehabilitation.)

Hyperpolarization is a technique that can increase nuclear spin polarization with the corresponding gains in nuclear magnetic resonance (NMR) signals by 4-8 orders of magnitude. When this process is applied to biologically relevant samples, the hyperpolarized molecules can be used as exogenous magnetic resonance imaging (MRI) contrast agents. A technique called spin-exchange optical pumping (SEOP) can be applied to hyperpolarize noble gases such as 129 Xe. Techniques based on hyperpolarized 129 Xe are poised to revolutionize clinical lung imaging, offering a non-ionizing, high-contrast alternative to computed tomography (CT) imaging and conventional proton MRI. Moreover, CT and conventional proton MRI report on lung tissue structure but provide little functional information. On the other hand, when a subject breathes hyperpolarized 129 Xe gas, functional lung images reporting on lung ventilation, perfusion and diffusion with 3D readout can be obtained in seconds. In this Review, the physics of SEOP is discussed and the different production modalities are explained in the context of their clinical application. We also briefly compare SEOP to other hyperpolarization methods and conclude this paper with the outlook for biomedical applications of hyperpolarized 129 Xe to lung imaging and beyond., (© 2021 Wiley-VCH GmbH.)

The American Heart Association/American Stroke Association released the adult stroke rehabilitation and recovery guidelines in 2016. A working group of stroke rehabilitation experts reviewed these guidelines and identified a subset of recommendations that were deemed suitable for creating performance measures. These 13 performance measures are reported here and contain inclusion and exclusion criteria to allow calculation of rates of compliance in a variety of settings ranging from acute hospital care to postacute care and care in the home and outpatient setting.

Background and Purpose: No data exists on whether proportional recovery (PR) is associated with health-related quality of life (HRQOL) domains. We evaluated whether PR was associated with domain-specific HRQOL scores at 3 months after ischemic stroke., Methods: This prospective cohort study enrolled patients with ischemic stroke between January 2017 and June 2018. Impaired strength was assessed using the Fugl-Meyer Upper Extremity (range, 0–66 points) and Motricity Index (range, 0–100 points) during index hospitalization and 3 months. Both measures are well-validated and reliable in patients with stroke to assesses motor functioning. PR (defined as 70% of difference between initial score and maximum possible recovery) was calculated from the initial measurements. HRQOL was measured using Neuro-QOL domains: upper extremity, depression, and cognition domains. PR was evaluated with HRQOL domains using binomial logistic regression., Results: Final analysis included 84 patients (mean age 67.8±16.4 years; 44% male; 51.2% White). For both Fugl-Meyer Upper Extremity and Motricity Index, the PR threshold was met for 48.8% of patients. Failure to meet Motricity Index PR was only associated with increased odds of HRQOL depression impairment (adjusted odds ratio, 11.8 [95% CI, 1.23–112.7]). Failure to meet Fugl-Meyer Upper Extremity PR threshold was not associated with HRQOL impairment after adjustment., Conclusions: Our findings suggest that reaching the PR threshold provides poor discrimination of HRQOL. Despite not meeting expected PR thresholds, patients can still maintain un-impaired HRQOL, suggesting other factors play a role in preserved HRQOL.

Background: Ischemic stroke can impact a patient's quality of life, but the extent is unknown., Objective: To evaluate the association between gait measures during inpatient rehabilitation with quality-of-life scores and function at 3 months in patients with stroke., Setting: Single-Center inpatient rehabilitation facility., Participants: Eight five patients with ischemic stroke., Methods: A 6-Minute Walk Test and a 10-Meter Walk Test were recorded on admission to rehabilitation. We analyzed the association between gait function at rehabilitation and 3-month quality of life and poor functional outcome (modified Rankin Scale score >2) using multivariable logistic regression., Main Outcome: Measures 3-month health related quality of life., Results: Eighty-five patients (mean age 68.3 14.9 years; 54.3% male) were enrolled. In adjusted analyses, an increase of 0.31 m/s (ie, 1 SD) on the 10-meter walk test was linked with a decreased odds of impaired lower extremity quality of life by 94% (odds ratio [OR] 0.06, 95% confidence interval [CI] 0.01-0.52; P =.01), and decreased odds of poor functional outcome by 98% (OR 0.02, 95% CI <0.01-0.47; P =.01). For the 6-minute walk test, an increase of 109.5 meters (ie, 1 SD) was linked with decreased odds of having impaired lower extremity quality of life by 1% (OR 0.99, 95% CI 0.98-1.00; P < .01) and poor functional outcome by 1% (OR 0.99, 95% CI 0.99-1.00; P = .04)., Conclusion: Gait measurements at rehabilitation can predict 3-month lower extremity quality of life and function., (© 2020 American Academy of Physical Medicine and Rehabilitation.)

Objective: More studies are needed on how depressive symptoms in stroke patients can impact outcomes. We evaluated the relationship between depression symptom severity and motor outcomes in a cohort of patients with motor impairment from ischemic stroke., Method: We enrolled consecutive ischemic stroke patients without a clinical diagnosis of depression who presented to a single-center urban academic referral hospital. The Patient Health Questionnaire-9 (PHQ-9) scale was used to measure depression symptom severity at three months. Three assessments of motor function were collected at stroke onset and three months: Fugl-Meyer upper extremity (FM-UE), Motricity Index, and Action Research Arm Test (ARAT). We assessed the association between three-month severity on PHQ-9 scores with the outcome measures using univariable and multivariable linear regression models., Results: Fifty-seven patients (mean age 67.8 ± 17.0 years; 50.9% male; 59.6% Caucasian) were included in the final analysis. Mean (standard deviation) outcome scores at three months were PHQ-9: 6.39 (5), Motricity Index: 86.93 (30.04), FM-UE: 52.67 (17.83), and ARAT: 43.77 (20.03). After adjusting for age, initial National Institute of Health Stroke Scale, and if patient discharged after hospitalization on a selective serotonin reuptake inhibitor, sex, and baseline motor outcome, we found that for every point increase in PHQ-9, the Motricity Index decreased by 0.82 points (p = 0.02) and the FM-UE decreased by 0.77 points (p = 0.049)., Conclusion: Depressive symptoms are common in the stroke population. Depressive symptoms after stroke are associated with multiple types of motor impairments. We need better understanding of the biologic and psychologic aspects of depression involved in stroke recovery.

Objective: The aim of this study was to determine whether the arm subscore of the Motricity Index 1 wk after stroke can predict recovery of upper limb function according to the Action Research Arm Test before inpatient rehabilitation facility discharge and at 3-mo outpatient follow-up., Design: This was a prospective cohort study of patients with acute ischemic stroke admitted to a single acute care hospital and affiliated inpatient rehabilitation facility between 2016 and 2018. Upper limb dexterity of the impaired limb was assessed using the arm subscore of the Motricity Index and Action Research Arm Test. Receiver operating characteristic curve analysis was used to determine optimal cutoffs of the initial arm subscore of the Motricity Index for a good functional outcome defined as Action Research Arm Test score of 45 or higher., Results: Ninety-five patients were evaluated at median 6, 26, and 98.5 days after stroke. The median (interquartile range) arm subscore of the Motricity Index at 1 wk was 77 (20.3-93). The median (interquartile range) Action Research Arm Test scores before inpatient rehabilitation facility discharge and at 3-mo outpatient follow-up were 33 (3.5-52) and 52 (34-55.8), respectively. The optimal arm subscore of the Motricity Index to predict Action Research Arm Test score of 45 or higher before inpatient rehabilitation facility discharge and at 3-mo outpatient follow-up were 71 and 58, respectively., Conclusions: Early arm subscore of the Motricity Index at 1 wk predicts upper limb functional capacity before inpatient rehabilitation facility discharge and at 3-mo outpatient follow-up.

The management of pain in persons with neurological injuries is challenging and complex. A holistic view and clinical approach are necessary when addressing pain in patients with neurological impairment because interpreting signs and symptoms and deciphering sources of pain is never a straightforward process. This problem is further magnified with the management of central pain syndromes. The best approach is to have a good understanding of the clinical characteristics commonly found in this patient population, in particular for patients with stroke, multiple sclerosis (MS), or spinal cord injury (SCI), as central pain manifests differently between these groups. This paper will focus on the history, clinical presentation, pathophysiology, assessment, and treatment of central pain in patients with these types of neurological conditions. In addition to being at risk for a decline in quality of life, patients with pain syndromes are also prone to adverse responses to treatments (e.g., opioid addiction). It is therefore important to methodically analyze the similarities and differences between patients with different pain syndromes.

It is likely that transcranial magnetic brain stimulation will be used for the clinical treatment of stroke and stroke-related impairments in the future. The anatomic target and stimulation parameters will likely vary for any clinical focus, be it weakness, pain, or cognitive or communicative dysfunction. Biomarkers may also be useful for identifying patients who will respond best, with a goal to enhance clinical decision making. Combination with drugs or specific types of therapeutic exercise may be necessary to achieve maximal response., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Objective: To evaluate the association between functional measures at admission to acute inpatient rehabilitation (AIR) and health-related quality of life (HRQOL) scores at 3 months after ischemic stroke., Design: Consecutive patients with ischemic stroke admitted to AIR were consented to a prospective registry., Setting: Large academic referral inpatient rehabilitation hospital., Participants: Patients (N=113) with ischemic stroke (mean age 70.6 ± 14.5y; 54.0% male; 56.6% white) were included in the analysis., Interventions: Not applicable., Main Outcome Measures: Admission FIM and Berg Balance Scores (BBS) were abstracted when available. The Neuro-Quality of Life questionnaire was used to assess 3-month HRQOL in 4 domains: upper extremity (UE), lower extremity (LE), executive functions (EF), and general concerns (GC). Associations of FIM and BBS scores with impaired HRQOL at 3 months were evaluated., Results: The median time from stroke onset to admission FIM and BBS was 6.4 (interquartile range [IQR] 4.2-11.3) and 8.9 (IQR 5.8-14.4) days, respectively. A 5-point increase in admission FIM score decreased the likelihood of impairment in HRQOL at 3 months by 25% for GC (odds ratio [OR] 0.75, 95% confidence interval [CI] 0.61-0.93, P=.01), 31% for EF (OR 0.69, 95% CI 0.56-0.85, P=.001), 16% for UE function (OR 0.84, 95% CI 0.73-0.96, P=.01), and 21% for LE function (OR 0.79, 95% CI 0.67-0.93 P=.004). A 5-point increase in admission BBS decreased the likelihood of impairment in HRQOL domains at 3 months by 15% for UE function (OR 0.85, 95% CI 0.75-0.98, P=.02) and 25% for LE function (OR 0.75, 95% CI 0.64-0.89, P=.001)., Conclusions: Admission FIM and BBS were strongly associated with 3-month HRQOL associated across multiple domains following stroke. These findings indicate that HRQOL can be predicted earlier in a patient's course during AIR., (Copyright © 2018 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.)

Background and Purpose- We aimed to determine whether low-frequency electric field navigated repetitive transcranial magnetic stimulation to noninjured motor cortex versus sham repetitive transcranial magnetic stimulation avoiding motor cortex could improve arm motor function in hemiplegic stroke patients when combined with motor training. Methods- Twelve outpatient US rehabilitation centers enrolled participants between May 2014 and December 2015. We delivered 1 Hz active or sham repetitive transcranial magnetic stimulation to noninjured motor cortex before each of eighteen 60-minute therapy sessions over a 6-week period, with outcomes measured at 1 week and 1, 3, and 6 months after end of treatment. The primary end point was the percentage of participants improving ≥5 points on upper extremity Fugl-Meyer score 6 months after end of treatment. Secondary analyses assessed changes on the upper extremity Fugl-Meyer and Action Research Arm Test and Wolf Motor Function Test and safety. Results- Of 199 participants, 167 completed treatment and follow-up because of early discontinuation of data collection. Upper extremity Fugl-Meyer gains were significant for experimental ( P<0.001) and sham groups ( P<0.001). Sixty-seven percent of the experimental group (95% CI, 58%-75%) and 65% of sham group (95% CI, 52%-76%) improved ≥5 points on 6-month upper extremity Fugl-Meyer ( P=0.76). There was also no difference between experimental and sham groups in the Action Research Arm Test ( P=0.80) or the Wolf Motor Function Test ( P=0.55). A total of 26 serious adverse events occurred in 18 participants, with none related to the study or device, and with no difference between groups. Conclusions- Among patients 3 to 12 months poststroke, goal-oriented motor rehabilitation improved motor function 6 months after end of treatment. There was no difference between the active and sham repetitive transcranial magnetic stimulation trial arms. Clinical Trial Registration- URL: https://www.clinicaltrials.gov . Unique identifier: NCT02089464.

Ankle movement training is important in motor recovery post stroke and early intervention is critical to stroke rehabilitation. However, acute stroke survivors receive motor rehabilitation in only a small fraction of time, partly due to the lack of effective devices and protocols suitable for early in-bed rehabilitation. Considering the first few months post stroke is critical in stroke recovery, there is a strong need to start motor rehabilitation early, mobilize the ankle, and conduct movement therapy. This study seeks to address the need and deliver intensive passive and active movement training in acute stroke using a wearable ankle robotic device. Isometric torque generation mode under real-time feedback is used to guide patients in motor relearning. In the passive stretching mode, the wearable robotic device stretches the ankle throughout its range of motion to the extreme dorsiflexion forcefully and safely. In the active movement training mode, a patient is guided and motivated to actively participate in movement training through game playing. Clinical testing of the wearable robotic device on 10 acute stroke survivors over 12 sessions of feedback-facilitated isometric torque generation, and passive and active movement training indicated that the early in-bed rehabilitation could have facilitated neuroplasticity and helped improve motor control ability.

Purpose: The aim of this guideline is to provide a synopsis of best clinical practices in the rehabilitative care of adults recovering from stroke., Methods: Writing group members were nominated by the committee chair on the basis of their previous work in relevant topic areas and were approved by the American Heart Association (AHA) Stroke Council's Scientific Statement Oversight Committee and the AHA's Manuscript Oversight Committee. The panel reviewed relevant articles on adults using computerized searches of the medical literature through 2014. The evidence is organized within the context of the AHA framework and is classified according to the joint AHA/American College of Cardiology and supplementary AHA methods of classifying the level of certainty and the class and level of evidence. The document underwent extensive AHA internal and external peer review, Stroke Council Leadership review, and Scientific Statements Oversight Committee review before consideration and approval by the AHA Science Advisory and Coordinating Committee., Results: Stroke rehabilitation requires a sustained and coordinated effort from a large team, including the patient and his or her goals, family and friends, other caregivers (eg, personal care attendants), physicians, nurses, physical and occupational therapists, speech-language pathologists, recreation therapists, psychologists, nutritionists, social workers, and others. Communication and coordination among these team members are paramount in maximizing the effectiveness and efficiency of rehabilitation and underlie this entire guideline. Without communication and coordination, isolated efforts to rehabilitate the stroke survivor are unlikely to achieve their full potential., Conclusions: As systems of care evolve in response to healthcare reform efforts, postacute care and rehabilitation are often considered a costly area of care to be trimmed but without recognition of their clinical impact and ability to reduce the risk of downstream medical morbidity resulting from immobility, depression, loss of autonomy, and reduced functional independence. The provision of comprehensive rehabilitation programs with adequate resources, dose, and duration is an essential aspect of stroke care and should be a priority in these redesign efforts. (Stroke.2016;47:e98-e169. DOI: 10.1161/STR.0000000000000098.)., (© 2016 American Heart Association, Inc.)

Background: This prospective, single-blinded, multicenter study assessed the safety and efficacy of electrical epidural motor cortex stimulation (EECS) in improving upper limb motor function of ischemic stroke patients with moderate to moderately severe hemiparesis., Methods: Patients ≥ 4 months poststroke were randomized 2:1 to an investigational (n = 104) or control (n = 60) group, respectively. Investigational patients were implanted (n = 94) with an epidural 6-contact lead perpendicular to the primary motor cortex and a pulse generator. Both groups underwent 6 weeks of rehabilitation, but EECS was delivered to investigational patients during rehabilitation. The primary efficacy endpoint (PE) was defined as attaining a minimum improvement of 4.5 points in the upper extremity Fugl-Meyer (UEFM) scale as well as 0.21 points in the Arm Motor Ability Test (AMAT) 4 weeks postrehabilitation. Follow-up assessments were performed 1, 4, 12, and 24 weeks postrehabilitation. Safety was evaluated by monitoring adverse events (AEs) that occurred between enrollment and the end of rehabilitation., Results: Primary intent-to-treat analysis showed no group differences at 4 weeks, with PE being met by 32% and 29% of investigational and control patients, respectively (P = .36). Repeated-measures secondary analyses revealed no significant treatment group differences in mean UEFM or AMAT scores. However, post hoc comparisons showed that a greater proportion of investigational (39%) than control (15%) patients maintained or achieved PE (P = .003) at 24 weeks postrehabilitation. Investigational group mean AMAT scores also improved significantly (P < .05) when compared to the control group at 24 weeks postrehabilitation. Post hoc analyses also showed that 69% (n = 9/13) of the investigational patients who elicited movement thresholds during stimulation testing met PE at 4 weeks, and mean UEFM and AMAT scores was also significantly higher (P < .05) in this subgroup at the 4-, 12-, and 24-week assessments when compared to the control group. Headache (19%), pain (13%), swelling (7%), and infection (7%) were the most commonly observed implant procedure-related AEs. Overall, there were 11 serious AEs in 9 investigational group patients (7 procedure related, 4 anesthesia related)., Conclusions: The primary analysis pertaining to efficacy of EECS during upper limb motor rehabilitation in chronic stroke patients was negative at 4 weeks postrehabilitation. A better treatment response was observed in a subset of patients eliciting stimulation induced upper limb movements during motor threshold assessments performed prior to each rehabilitation session. Post hoc comparisons indicated treatment effect differences at 24 weeks, with the control group showing significant decline in the combined primary outcome measure relative to the investigational group. These results have the potential to inform future chronic stroke rehabilitation trial design., (© The Author(s) 2015.)

Objective: To examine agreement between patient and proxy responses on the Quality of Life in Neurological Disorders (Neuro-QoL) instruments after stroke., Design: Cross-sectional observational substudy of the longitudinal, multisite, multicondition Neuro-QoL validation study., Setting: In-person, interview-guided, patient-reported outcomes., Participants: Convenience sample of dyads (N=86) of community-dwelling persons with stroke and their proxy respondents., Interventions: Not applicable., Main Outcome Measures: Dyads concurrently completed short forms of 8 or 9 items for the 13 Neuro-QoL adult domains using the patient-proxy perspective. Agreement was examined at the scale-level with difference scores, intraclass correlation coefficients (ICCs), effect size statistics, and Bland-Altman plots, and at the item-level with kappa coefficients., Results: We found no mean differences between patients and proxies on the Applied Cognition-General Concerns, Depression, Satisfaction With Social Roles and Activities, Stigma, and Upper Extremity Function (Fine Motor, activities of daily living) short forms. Patients rated themselves more favorably on the Applied Cognition-Executive Function, Ability to Participate in Social Roles and Activities, Lower Extremity Function (Mobility), Positive Affect and Well-Being, Anxiety, Emotional and Behavioral Dyscontrol, and Fatigue short forms. The largest mean patient-proxy difference observed was 3 T-score points on the Lower Extremity Function (Mobility). ICCs ranged from .34 to .59. However, limits of agreement showed dyad differences exceeding ±20 T-score points, and item-level agreement ranged from not significant to weighted kappa=.34., Conclusions: Proxy responses on Neuro-QoL short forms can complement responses of moderate- to high-functioning community-dwelling persons with stroke and augment group-level analyses, but do not substitute for individual patient ratings. Validation is needed for other stroke populations., (Copyright © 2015 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.)

Predicting functional outcome in stroke is challenging to most clinicians, partly because of the complexity of the condition and also because of the lack of validated prognostic models. The strongest predictors of functional outcome are age and motor function at stroke onset. There is a growing literature on predicting recovery of upper limb after stroke; however, literature on prediction of language recovery remains sparse. This review covers the current status of predicting functional outcome after stroke focusing on recovery of activities of daily living, ambulation, upper limb use, and aphasia. Use of clinical factors, imaging, and neurophysiological measures are discussed., (Copyright © 2015 Elsevier Inc. All rights reserved.)

We implemented a quality improvement project to reduce noise levels in the OR in response to complaints from the anesthesia staff members at two community hospitals. Excessive noise has been shown to increase staff member stress, fatigue, distraction, and ineffective communication, which can lead to medical errors. We measured noise levels during anesthesia induction and emergence for 118 different surgical procedures and compared noise levels before and after the improvement project intervention. Staff member education and noise reduction strategies, which included signage, prominent noise meters, and specific suggestions to staff members, helped to significantly reduce the noise level during the anesthetic induction and emergence phases of OR procedures., (Copyright © 2015 AORN, Inc. Published by Elsevier Inc. All rights reserved.)

Calf muscles and Achilles tendon play important roles in functional activities. However, it is not clear how biomechanical properties of the uniarticular soleus (SOL) and biarticular gastrocnemius muscle and Achilles tendon, including the fascicle length, pennation angle, and stiffness, change concurrently post stroke. Biomechanical properties of the medial gastrocnemius (GM) and soleus muscles were evaluated bilaterally in 10 hemiparetic stroke survivors using combined ultrasonography-biomechanical measurements. Biomechanical properties of the Achilles tendon including the length, cross-sectional area (CSA), stiffness, and Young's modulus were evaluated, together with calf muscle biomechanical properties. Gastrocnemius and SOL contributions were separated using flexed and extended knee positions. The impaired side showed decreased fascicle length (GM: 6%, P = 0.002 and SOL: 9%, P = 0.03, at full knee extension and 0° ankle dorsiflexion) and increased fascicular stiffness (GM: 64%, P = 0.005 and SOL: 19%, P = 0.012, at a common 50 N force level). In contrast, Achilles tendon on the impaired side showed changes in the opposite direction as the muscle fascicles with increased tendon length (5%, P < 0.001), decreased tendon CSA (5%, P = 0.04), decreased tendon stiffness (42%, P < 0.001) and Young's modulus (30%, P < 0.001) compared with the unimpaired side. The fascicle and tendon stiffness changes were correlated negatively to the corresponding fascicle and tendon length changes, and decrease in Achilles tendon stiffness was correlated to the increases of SOL and GM fascicular stiffness (P < 0.05). Characterizations of calf muscle fascicles and Achilles tendon biomechanical properties help us better understand concurrent changes of fascicles and tendon as part of the calf muscle-tendon unit and facilitate development of more effective treatments., (Copyright © 2015 the American Physiological Society.)

Purpose: To illustrate the ethical challenges that arose from investigating a novel treatment procedure, transcranial direct current stimulation (tDCS), in a research participant with aphasia., Method: We review the current evidence supporting the use of tDCS in aphasia research, highlighting methodological gaps in our knowledge of tDCS. Then, we examine the case of Mr. C, a person with chronic aphasia who participated in a research protocol investigating the impact of tDCS on aphasia treatment. We describe the procedures that he underwent and the resulting behavioral and neurophysiological outcomes. Finally, we share the steps that were taken to balance beneficence and nonmaleficence and to ensure Mr. C's autonomy., Results: The objective data show that while Mr. C may not have benefitted from participating in the research, neither did he experience any harm., Conclusion: Researchers must consider not only the scientific integrity of their studies, but also potential ethical issues and consequences to the research participants.

Objectives: To investigate the effects of controlled passive stretching and active movement training using a portable rehabilitation robot on stroke survivors with ankle and mobility impairment., Methods: Twenty-four patients at least 3 months post stroke were assigned to receive 6 week training using the portable robot in a research laboratory (robot group) or an instructed exercise program at home (control group). All patients underwent clinical and biomechanical evaluations in the laboratory at pre-evaluation, post-evaluation, and 6-week follow-up., Results: Subjects in the robot group improved significantly more than that in the control group in reduction in spasticity measured by modified Ashworth scale, mobility by Stroke Rehabilitation Assessment of Movement (STREAM), the balance by Berg balance score, dorsiflexion passive range of motion, dorsiflexion strength, and load bearing on the affected limb during gait after 6-week training. Both groups improved in the STREAM, dorsiflexion active range of motion and dorsiflexor strength after the training, which were retained in the follow-up evaluation., Conclusion: Robot-assisted passive stretching and active movement training is effective in improving motor function and mobility post stroke.

Objective: The aim of this study was to assess the efficacy of botulinum toxin type A injections in reducing pain, impairment, and disability in patients who have had a stroke with shoulder pain and spasticity., Design: In this prospective randomized, double-blind, placebo-controlled trial, adults (n = 37) with post-stroke shoulder spasticity were screened for preinjection spasticity, rated 3 or 4 on the Modified Ashworth Scale for the shoulder adductors/internal rotators and shoulder pain. After the baseline screening, 21 subjects were randomized to receive either onabotulinumtoxinA (Botox; 140-200 units), into the pectoralis major with or without injections to the teres major, or placebo (saline) injections. Daily pain ratings using visual analog scales of best and worst pain and Disability Assessment Scale for dressing, hygiene, pain, and cosmesis; McGill Pain Questionnaire-Short Form; Fugl-Meyer Scale; upper limb range of motion; and Modified Ashworth Scale scores were assessed at baseline and 2, 4, and 12 wks after injection. Primary outcomes were assessed at week 4., Results: The subject groups were well matched at baseline. Both the botulinum toxin type A and placebo groups showed decreased pain scores at 4 wks (P's < 0.05), with no significant differences between the groups found for any of the daily pain ratings (P's > 0.05). Significant improvement (P < 0.05) in change scores for hygiene on the Disability Assessment Scale was found in the botulinum toxin type A group compared with the placebo group at week 4, and there was a similar trend toward significance for improvement on the Disability Assessment Scale dressing scale (P = 0.061)., Conclusions: Although botulinum toxin type A shoulder muscle injections in patients who have had a stroke with spasticity and shoulder pain resulted in improvement in selected disability measures, the observed pain reduction was not greater than that found for placebo.

Background: There are several methods of delivering cortical brain stimulation to modulate cortical excitability and interest in their application as an adjuvant strategy in aphasia rehabilitation after stroke is growing. Epidural cortical stimulation, although more invasive than other methods, permits high frequency stimulation of high spatial specificity to targeted neuronal populations., Aims: First, we review evidence supporting the use of epidural cortical stimulation for upper limb recovery after focal cortical injury in both animal models and human stroke survivors. These data provide the empirical and theoretical platform underlying the use of epidural cortical stimulation in aphasia. Second, we summarize evidence for the application of epidural cortical stimulation in aphasia. We describe the procedures and primary outcomes of a safety and feasibility study (Cherney, Erickson & Small, 2010), and provide previously unpublished data regarding secondary behavioral outcomes from that study., Main Contribution: In a controlled study comparing epidural cortical stimulation plus language treatment (CS/LT) to language treatment alone (LT), eight stroke survivors with nonfluent aphasia received intensive language therapy for 6 weeks. Four of these participants also underwent surgical implantation of an epidural stimulation device which was activated only during therapy sessions. Behavioral data were collected before treatment, immediately after treatment, and at 6 and 12 weeks following the end of treatment. The effect size for the primary outcome measure, the Western Aphasia Battery Aphasia Quotient, was benchmarked as moderate from baseline to immediately post-treatment, and large from baseline to the 12-week follow-up. Similarly, effect sizes obtained at the 12-week follow-up for the Boston Naming Test, the Communicative Effectiveness Index, and for correct information units on a picture description task were greater than those obtained immediately post treatment. When effect sizes were compared for individual subject pairs on discourse measures of content and rate, effects were typically larger for the investigational subjects receiving CS/LT than for the control subjects receiving LT alone. These analyses support previous findings regarding therapeutic efficacy of CS/LT compared to LT i.e. epidural stimulation of ipsilesional premotor cortex may augment behavioral speech-language therapy, with the largest effects after completion of therapy., Conclusions: Continued investigation of epidural cortical stimulation in combination with language training in post-stroke aphasia should proceed cautiously. Carefully planned studies that customize procedures to individual profiles are warranted. Information from research on non-invasive methods of CS/LT may also inform future studies of epidural cortical stimulation.

Purpose: Patients with stroke have a 2- to 4-fold increased risk of hip fracture compared to the general population, because of decreased bone mineral density (BMD) on the paretic side and the high incidence of accidental falls. However, the relationship between BMD and stroke-related motor impairment and functional mobility is not known. The purpose of this study was to investigate these relationships., Method: A convenience sample of 87 patients with stroke was recruited from an outpatient rehabilitation clinic. Demographics and clinical history were collected, and patients answered questionnaires regarding functional status. Motor impairment was assessed using motor items of the National Institutes of Health Stroke Scale (NIHSS), and BMD was measured using dual energy X-ray absorptiometry., Results: Mean BMD measured at the total hip was lower on the paretic side relative to the contralateral side (0.883 ± 0.148 g/cm2 vs 0.923 ± 0.136 g/cm2;P < .001). Compared to patients without limitations in walking, those reporting limitations had lower BMD at the paretic total hip (0.808 ± 0.141 g/cm2 vs 0.917 ± 0.139 g/cm2;P = .001) and lower BMDZ scores (-0.282 ± 0.888 vs -0.028 ± 0.813;P = .035). A significant correlation was found between mean BMD and the BMDZ score at the total hip on the paretic side and motor impairment in that lower extremity (r = -0.326,P = .003;r = -0.312,P = .004, respectively)., Conclusion: In patients with stroke, BMD at the paretic hip correlated with motor impairment. Furthermore, ability to ambulate was shown to be a simple yet useful test to determine which individuals had increased bone loss at the paretic versus nonparetichip.

Background: Spatial neglect affects perception along different dimensions. However, there is limited availability of 3-dimensional (3D) methods that fully map out a patient's volume of deficit, although this could guide clinical management., Objective: To test whether patients with neglect exhibit simple contralesional versus complex perceptual deficits and whether deficits are best described using Cartesian (rectangular) or polar coordinates., Methods: Seventeen right-hemisphere persons with stroke (8 with a history of neglect) and 9 healthy controls were exposed to a 3D virtual environment. Targets placed in a dense array appeared one at a time in various locations., Results: When tested using rectangular array of targets, subjects in the neglect group exhibited complex asymmetries across several dimensions in both reaction time and target detection rates. Paper-and-pencil tests only detected neglect in 4 of 8 of these patients. When tested using polar array of targets, 2 patients who initially appeared to perform poorly in both left and near space only showed a simple left-side asymmetry that depended almost entirely on the angle from the sagittal plane. A third patient exhibited left neglect irrespective of the arrangements of targets used. An idealized model with pure dependence on the polar angle demonstrated how such deficits could be misconstrued as near neglect if one uses a rectangular array., Conclusions: Such deficits may be poorly detected by paper-and-pencil tests and even by computerized tests that use regular screens. Assessments that incorporate 3D arrangements of targets enable precise mapping of deficient areas and detect subtle forms of neglect whose identification may be relevant to treatment strategies.

Objective: Up to 90% of embolic strokes that occur in patients with atrial fibrillation originate from the left atrial appendage. Exclusion of the left atrial appendage during cardiac surgery may decrease the future risk of stroke, especially in patients with atrial fibrillation or at high risk for developing atrial fibrillation. We report the initial results of a multicenter Food and Drug Administration trial to assess the safety and efficacy of a novel left atrial appendage exclusion clip., Methods: Patients undergoing elective cardiac surgery via median sternotomy with atrial fibrillation or a Congestive Heart Failure, Hypertension, Age > 75 Years, Diabetes Mellitus, Stroke score greater than 2 were eligible for concomitant AtriClip (Atricure Inc, Westchester, Ohio) device insertion. Device insertion (35, 40, 45, and 50 mm) was performed at any point after sternotomy on or off cardiopulmonary bypass. Safety was assessed at 30 days, and efficacy of left atrial appendage exclusion was assessed at operation (by transesophageal echocardiography) and 3-month follow-up (by computed tomography angiography or transesophageal echocardiography)., Results: A total of 71 patients (mean age, 73 years) undergoing open cardiac surgery at 7 US centers were enrolled in the study. The left atrial appendage in 1 patient was too small and did not meet eligibility criteria; the remaining 70 patients had successful placement of an AtriClip device. Intraprocedural successful left atrial appendage exclusion was confirmed in 67 of 70 patients (95.7%). Although significant adverse events occurred in 34 of 70 patients (48.6%), there were no adverse events related to the device and no perioperative mortality. At 3-month follow-up, 1 patient died and 65 of 70 patients (92.9%) were available for assessment. Of the patients who underwent imaging, 60 of 61 patients (98.4%) had successful left atrial appendage exclusion by computed tomography angiography or transesophageal echocardiography imaging., Conclusions: In this small study, safe and atraumatic exclusion of the left atrial appendage can be performed during open cardiac surgery with the AtriClip device with greater than 95% success and appears to be durable in the short term by imaging. Long-term studies are needed to evaluate the efficacy in the prevention of stroke., (Copyright © 2011 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.)

Movement training is important in motor recovery post stroke and early intervention is critical to stroke rehabilitation. However, acute stroke survivors are actively trained with activities helpful for recovery of mobility in only 13% of the time in the acute phase. Considering the first few months post stroke is critical in stroke recovery (neuroplasticity), there is a strong need for movement therapy and manipulate/mobilize the joints. There is a lack of in-bed robotic rehabilitation in acute stroke. This study seeks to meet the clinic need and deliver intensive passive and active movement therapy using a wearable robot to enhance motor function in acute stroke. Passively, the wearable robot stretches the joint to its extreme positions safely and forcefully. Actively, movement training is conducted and game playing is used to guide and motivate the patient in movement training.

Recovery of upper limb function after stroke remains a clinical challenge in rehabilitation. New insights into the role of activity-dependent motor recovery have guided clinicians to develop novel task-oriented therapies that are effective in reducing functional limitations in hand use after stroke. A number of brain-stimulation techniques have been examined as therapeutic adjuvants applied to enhance functional outcomes. Cortical stimulation with the use of either noninvasive techniques or implanted technology has shown some promise as an adjuvant therapy but has yet to be supported in well-designed clinical trials. In this article, we review the physiology of neural plasticity and of cortical stimulation. Laboratory studies and early clinical trials of repetitive transcranial magnetic stimulation, transcranial direct current stimulation, and epidural cortical stimulation are reported. Cortical stimulation may have a role in facilitating motor recovery after stroke, but a better understanding of the physics of cortical stimulation, biological response to stimulation, effective stimulation protocols, and proper patient selection is needed., (Copyright © 2010 American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved.)

Central poststroke pain (CPSP) syndrome is a rare complication of stroke but a common cause of central pain. CPSP is best managed in a well-coordinated interdisciplinary pain management program. Pharmacological options are available but none have proven optimal efficacy. Adequate pain control can be achieved with careful medication adjustment and a willingness to try different options in a stepwise approach. Motor cortex stimulation (MCS) with noninvasive or implanted electrodes is not currently available in the United States but has shown good efficacy in several clinical trials. MCS combined with medication management may be an option for treating CPSP in the future.

Neurorehabilitation is a critical part of the overall process to achieve optimal outcome after stroke. Presently, the field of neurorehabilitation is in transition. New research suggesting novel approaches to optimize functional recovery after stroke is on the horizon, but clear knowledge of the underlying mechanisms of this recovery is still being unraveled. In practice, many rehabilitation centers continue to provide traditional compensatory rehabilitation training while many others are practicing newer, "task-oriented" approaches. A few centers are incorporating new technology, such as computer-based training devices or robotics, into rehabilitation care. This transition is happening because neuroscientific research has shown that neuroplastic changes in the cerebral cortex and in other parts of the central nervous system (CNS) are necessarily linked to motor skill retraining in the affected limbs. Task-oriented training that focuses on the practice of skilled motor performance is the critical link to facilitating neural reorganization and "rewiring" in the CNS. Therefore, whenever possible, task-oriented training at an intense level should be incorporated into the rehabilitation program of any patient with stroke-related motor deficits. Two such task-oriented therapies that should be available at all neurorehabilitation centers are constraint-induced movement therapy and body weight-supported treadmill training. The optimal intensity of training (frequency and duration) is still not clear but is certainly greater than that available in clinical programs. Therefore, the incorporation of automated training devices will be necessary in the future. However, the engineering necessary to make these devices effective, easy to use, affordable, and portable remains a challenge for the next decade of neurologic bioengineering research.