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The Critical Periods After Stroke Study (CPASS, n = 72) showed that, compared to controls, an additional 20 hours of intensive upper limb therapy led to variable gains on the Action Research Arm Test depending on when therapy was started post-stroke: the subacute group (2-3 months) improved beyond the minimal clinically important difference and the acute group (0-1 month) showed smaller but statistically significant improvement, but the chronic group (6-9 months) did not demonstrate improvement that reached significance. Some have misinterpreted CPASS results to indicate that all inpatient motor therapy should be shifted to outpatient therapy delivered 2 to 3 months post-stroke. Instead, however, CPASS argues for a large dose of motor therapy delivered continuously and cumulatively during the acute and subacute phases. When interpreting trials like CPASS, one must consider the substantial dose of early usual customary care (UCC) motor therapy that all participants received. CPASS participants averaged 27.9 hours of UCC occupational therapy (OT) during the first 2 months and 9.8 hours of UCC OT during the third and fourth months post-stroke. Any recovery experienced would therefore result not just from CPASS intensive motor therapy but the combined effects of experimental therapy plus UCC. Statistical limitations also did not allow direct comparisons of the acute and subacute group outcomes in CPASS. Instead of shifting inpatient therapy hours to the subacute phase, CPASS argues for preserving inpatient UCC. We also recommend conducting multi-site dosing trials to determine whether additional intensive motor therapy delivered in the first 2 to 3 months following inpatient rehabilitation can further improve outcomes.

Background Wrist-worn accelerometry provides objective monitoring of upper-extremity functional use, such as reaching tasks, but also detects nonfunctional movements, leading to ambiguity in monitoring results. Objective Compare machine learning algorithms with standard methods (counts ratio) to improve accuracy in detecting functional activity. Methods Healthy controls and individuals with stroke performed unstructured tasks in a simulated community environment (Test duration = 26 ± 8 minutes) while accelerometry and video were synchronously recorded. Human annotators scored each frame of the video as being functional or nonfunctional activity, providing ground truth. Several machine learning algorithms were developed to separate functional from nonfunctional activity in the accelerometer data. We also calculated the counts ratio, which uses a thresholding scheme to calculate the duration of activity in the paretic limb normalized by the less-affected limb. Results The counts ratio was not significantly correlated with ground truth and had large errors ( r = 0.48; P = .16; average error = 52.7%) because of high levels of nonfunctional movement in the paretic limb. Counts did not increase with increased functional movement. The best-performing intrasubject machine learning algorithm had an accuracy of 92.6% in the paretic limb of stroke patients, and the correlation with ground truth was r = 0.99 ( P < .001; average error = 3.9%). The best intersubject model had an accuracy of 74.2% and a correlation of r =0.81 ( P = .005; average error = 5.2%) with ground truth. Conclusions In our sample, the counts ratio did not accurately reflect functional activity. Machine learning algorithms were more accurate, and future work should focus on the development of a clinical tool.

Background. As stroke survival improves, there is an increasing need for effective, low-cost programs to reduce deconditioning and improve mobility. Objective. To conduct a phase II trial examining whether the community-based Italian Adaptive Physical Activity exercise program for stroke survivors (APA-Stroke) is safe, effective, and feasible in the United States. Methods. In this single-blind, randomized controlled trial, 76 stroke survivors with mild to moderate hemiparesis >6 months were randomized to either APA-Stroke (N = 43) or Sittercise (N = 33). APA-Stroke is a progressive group exercise regimen tailored to hemiparesis that includes walking, strength, and balance training. Sittercise, a seated, nonprogressive aerobic upper body general exercise program, served as the control. Both interventions were 1 hour, 3 times weekly, in 5 community locations, supervised by exercise instructors. Results. A total of 76 participants aged 63.9 ± 1.2 years, mean months poststroke 61.8 ± 9.3, were included. There were no serious adverse events; completion rates were 58% for APA-Stroke, 70% for Sittercise. APA-Stroke participants improved significantly in walking speed. Sample size was inadequate to demonstrate significant between-group differences. Financial and logistical feasibility of the program has been demonstrated. Ongoing APA classes have been offered to >200 participants in county Senior Centers since study completion. Conclusion. APA-Stroke shows great promise as a low-cost, feasible intervention. It significantly increased walking speed. Safety and feasibility in the US context are demonstrated. A pivotal clinical trial is required to determine whether APA-Stroke should be considered standard of care.

Background. Task-oriented therapies have been developed to address significant upper extremity disability that persists after stroke. Yet, the extent of and approach to rehabilitation and recovery remains unsatisfactory to many. Objective. To compare a skill-directed investigational intervention with usual care treatment for body functions and structures, activities, participation, and quality of life outcomes. Methods. On average, 46 days poststroke, 361 patients were randomized to 1 of 3 outpatient therapy groups: a patient-centered Accelerated Skill Acquisition Program (ASAP), dose-equivalent usual occupational therapy (DEUCC), or usual therapy (UCC). Outcomes were taken at baseline, posttreatment, 6 months, and 1 year after randomization. Longitudinal mixed effect models compared group differences in poststroke improvement during treatment and follow-up phases. Results. Across all groups, most improvement occurred during the treatment phase, followed by change more slowly during follow-up. Compared with DEUCC and UCC, ASAP group gains were greater during treatment for Stroke Impact Scale Hand, Strength, Mobility, Physical Function, and Participation scores, self-efficacy, perceived health, reintegration, patient-centeredness, and quality of life outcomes. ASAP participants reported higher Motor Activity Log–28 Quality of Movement than UCC posttreatment and perceived greater study-related improvements in quality of life. By end of study, all groups reached similar levels with only limited group differences. Conclusions. Customized task-oriented training can be implemented to accelerate gains across a full spectrum of patient-reported outcomes. While group differences for most outcomes disappeared at 1 year, ASAP participants achieved these outcomes on average 8 months earlier (ClinicalTrials.gov: Interdisciplinary Comprehensive Arm Rehabilitation Evaluation [ICARE] Stroke Initiative, at www.ClinicalTrials.gov/ClinicalTrials.gov . Identifier: NCT00871715).

Background. Stroke patients with mild-moderate upper extremity motor impairments and minimal sensory and cognitive deficits provide a useful model to study recovery and improve rehabilitation. Laboratory-based investigators use lesioning techniques for similar goals. Objective. To determine whether stroke lesions in an upper extremity rehabilitation trial cohort match lesions from the preclinical stroke recovery models used to drive translational research. Methods. Clinical neuroimages from 297 participants enrolled in the Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE) study were reviewed. Images were characterized based on lesion type (ischemic or hemorrhagic), volume, vascular territory, depth (cortical gray matter, cortical white matter, subcortical), old strokes, and leukoaraiosis. Lesions were compared with those of preclinical stroke models commonly used to study upper limb recovery. Results. Among the ischemic stroke participants, median infarct volume was 1.8 mL, with most lesions confined to subcortical structures (61%) including the anterior choroidal artery territory (30%) and the pons (23%). Of ICARE participants

Background. A common assumption is that changes in upper limb (UL) capacity, or what an individual is capable of doing, translates to improved UL performance in daily life, or what an individual actually does. This assumption should be explicitly tested for individuals with UL paresis poststroke. Objective. To examine changes in UL performance after an intensive, individualized, progressive, task-specific UL intervention for individuals at least 6 months poststroke. Methods. Secondary analysis on 78 individuals with UL paresis who participated in a phase II, single-blind, randomized parallel dose-response trial. Participants were enrolled in a task-specific intervention for 8 weeks. Participants were randomized into 1 of 4 treatment groups with each group completing different amounts of UL movement practice. UL performance was assessed with bilateral, wrist-worn accelerometers once a week for 24 hours throughout the duration of the study. The 6 accelerometer variables were tested for change and the influence of potential modifiers using hierarchical linear modeling. Results. No changes in UL performance were found on any of the 6 accelerometer variables used to quantify UL performance. Neither changes in UL capacity nor the overall amount of movement practice influenced changes in UL performance. Stroke chronicity, baseline UL capacity, concordance, and ADL status significantly increased the baseline starting points but did not influence the rate of change (slopes) for participants. Conclusions. Improved motor capacity resulting from an intensive outpatient UL intervention does not appear to translate to increased UL performance outside the clinic.

In well-recovered stroke patients with preserved hand movement, motor dysfunction relates to interhemispheric and intracortical inhibition in affected hand muscles. In less fully recovered patients unable to move their hand, the neural substrates of recovered arm movements, crucial for performance of daily living tasks, are not well understood. Here, we evaluated interhemispheric and intracortical inhibition in paretic arm muscles of patients with no recovery of hand movement (n = 16, upper extremity Fugl-Meyer Assessment = 27.0 ± 8.6). We recorded silent periods (contralateral and ipsilateral) induced by transcranial magnetic stimulation during voluntary isometric contraction of the paretic biceps and triceps brachii muscles (correlates of intracortical and interhemispheric inhibition, respectively) and investigated links between the silent periods and motor recovery, an issue that has not been previously explored. We report that interhemispheric inhibition, stronger in the paretic triceps than biceps brachii muscles, significantly correlated with the magnitude of residual impairment (lower Fugl-Meyer scores). In contrast, intracortical inhibition in the paretic biceps brachii, but not in the triceps, correlated positively with motor recovery (Fugl-Meyer scores) and negatively with spasticity (lower Modified Ashworth scores). Our results suggest that interhemispheric inhibition and intracortical inhibition of paretic upper arm muscles relate to motor recovery in different ways. While interhemispheric inhibition may contribute to poorer recovery, muscle-specific intracortical inhibition may relate to successful motor recovery and lesser spasticity.

Background. One important objective for clinical trialists in rehabilitation is determining efficacy of interventions to enhance motor behavior. In part, limitation in the precision of measurement presents a challenge. The few valid, low-cost observational tools available to assess motor behavior cannot escape the variability inherent in test administration and scoring. This is especially true when there are multiple evaluators and raters, as in the case of multisite randomized controlled trials (RCTs). One way to enhance reliability and reduce variability is to implement rigorous quality control (QC) procedures. Objective. This article describes a systematic QC process used to refine the administration and scoring procedures for the Wolf Motor Function Test (WMFT)–Functional Ability Scale (FAS). Methods. The QC process, a systematic focus-group collaboration, was developed and used for a phase III RCT, which enlisted multiple evaluators and an experienced WMFT-FAS rater panel. Results. After 3 staged refinements to the administration and scoring instructions, we achieved a sufficiently high interrater reliability (weighted κ = 0.8). Conclusions and Implications. A systematic focus-group process was shown to be an effective method to improve reliability of observational assessment tools for motor behavior in neurorehabilitation. A reduction in noise-related variability in performance assessments will increase power and potentially lower the number needed to treat. Improved precision of measurement can lead to more cost-effective and efficient clinical trials. Finally, we suggest that improved precision in measures of motor behavior may provide more insight into recovery mechanisms than a single measure of movement time alone.

Background. Studies have demonstrated the efficacy of functional electrical stimulation in the management of foot drop after stroke. Objective. To compare changes in walking performance with the WalkAide (WA) foot-drop stimulator and a conventional ankle–foot orthosis (AFO). Methods. Individuals with stroke within the previous 12 months and residual foot drop were enrolled in a multicenter, randomized controlled, crossover trial. Subjects were assigned to 1 of 3 parallel arms for 12 weeks (6 weeks/device): arm 1 (WA–AFO), n = 38; arm 2 (AFO–WA), n = 31; arm 3 (AFO–AFO), n = 24. Primary outcomes were walking speed and Physiological Cost Index for the Figure-of-8 walking test. Secondary measures included 10-m walking speed and perceived safety during this test, general mobility, and device preference for arms 1 and 2 for continued use. Walking tests were performed with (On) and without a device (Off) at 0, 3, 6, 9, and 12 weeks. Results. Both WA and AFO had significant orthotic (On–Off difference), therapeutic (change over time when Off), and combined (change over time On vs baseline Off) effects on walking speed. An AFO also had a significant orthotic effect on Physiological Cost Index. The WA had a higher, but not significantly different therapeutic effect on speed than an AFO, whereas an AFO had a greater orthotic effect than the WA (significant at 12 weeks). Combined effects on speed after 6 weeks did not differ between devices. Users felt as safe with the WA as with an AFO, but significantly more users preferred the WA. Conclusions. Both devices produce equivalent functional gains.

Rationale PROTECT DC examines whether stroke navigators can improve cardiovascular risk factors in urban underserved individuals newly hospitalized for stroke or ischemic attack. Within one-year of hospital discharge, up to one-third of patients no longer adhere to secondary prevention behaviors. Adherence rates are lower in minority-underserved groups, contributing to health disparities. In-hospital programs increase use of stroke prevention therapies but may not be as successful in underserved individuals. In these groups, low literacy, limited healthcare access, and sparse community resources may reduce adherence. Lay community health workers (navigators) improve adherence in other illnesses through education and assisting in overcoming barriers to achieving desired health behaviors and obtaining needed healthcare services. Aims and design PROTECT DC is a Phase II, single-blind, randomized, controlled trial comparing in-hospital education plus stroke navigators to usual care. Atherogenic ischemic stroke and transient ischemic attack survivors are recruited from Washington, DC hospitals. Navigators meet with participants during the index hospitalization, perform home visits, and meet by phone. They focus on stroke education, medication compliance, and overcoming practical barriers to adherence. The interventions are driven by the theories of reasoned action and planned behavior. Study outcomes The primary dependent measure is a summary score of four objective measures of stroke risk factor control: systolic blood pressure, low-density lipoprotein, hemoglobin Hb A1C, and antiplatelet agent pill counts. Secondary outcomes include stroke knowledge, exercise, dietary modification, and smoking cessation. Conclusion PROTECT DC will determine whether a Phase III trial of stroke navigation for urban underserved individuals to improve adherence to secondary stroke prevention behaviors is warranted.

Background and Objective. The authors recently found that grasping was not relatively more disrupted than reaching in people with acute hemiparesis. They now extend this work to the recovery of reach versus grasp. Methods. Hemiparetic subjects were tested acutely, after 90 days, and then after 1 year poststroke, and a control group was evaluated once. Using kinematic techniques, subjects were studied performing reach and reach-to-grasp movements. The authors quantified 3 characteristics of performance for each movement: speed, accuracy, and efficiency, where an efficient movement was defined as a movement directly to the target without extraneous or abnormally circuitous movements. To evaluate the relative deficits and recovery in reach versus grasp, performance measures were converted to z scores using control group means and standard deviations. Results. The authors’ results showed that, starting with small deficits in speed acutely, both reach speed and grasp speed improved over time. Deficits in accuracy were greater in the reach than the grasp acutely, and these deficits lessened such that by the 90-day time point, the relative accuracy of the 2 movements was the same. In contrast, deficits in efficiency were greater in the grasp than the reach acutely, and grasp efficiency did not recover. The majority of recovery in reaching and grasping occurred by the 90-day time point, with little change occurring between the 90-day and 1-year time points. Conclusions. The authors hypothesize that, in chronic hemiparesis, purposeful movements requiring distal control may be more impaired than purposeful movements requiring proximal control, not because of the initial lesion, but because, over the course of recovery, spared components of the descending motor systems may be able to compensate for the accuracy deficits in reaching (proximal control) but not the efficiency deficits in grasping (distal muscular control).

Background. The authors assessed patients with acute stroke to determine whether the systematic use of brief screening measures would more efficiently detect cognitive and sensory impairment than standard clinical practice. Methods. Fifty-three patients admitted to an acute stroke unit were assessed within 10 days of stroke onset. Performance on the screening measures was compared to information obtained from review of the patient’s chart at discharge. Cognition, language, visual acuity, visual-spatial neglect, hearing, and depression were evaluated. Results. Formal screening detected significantly more impairments than were noted in patient charts in every domain. Only 3 patients had no impairments identified on screening; all remaining patients had at least 1 impairment detected by screening that was not documented in the chart. Thirty-five percent had 3 or more undetected impairments. Memory impairment was most likely to be noted in the chart; for all other domains tested, undocumented impairment ranged from 61% (neglect) to 97% (anomia). Conclusion. Many acute stroke patients had cognitive and perceptual deficits that were not documented in their charts. These data support the Post-Stroke Rehabilitation Guidelines for systematic assessment even when deficits are not immediately apparent. Systematic screening may improve discharge planning, rehabilitation treatment, and long-term outcome of persons with stroke.