Arm Rehabilitation Study After Stroke

Study Overview
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Brief Summary
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This study is about arm and hand recovery after a stroke. The investigators are testing an experimental arm therapy called Accelerated Skill Acquisition Program (ASAP) which combines challenging, intensive and meaningful practice of tasks of the participant's choice compared to two standard types of therapy (usual and customary arm therapy totaling 30 hours and usual and customary arm therapy for a duration indicated on the therapy prescription). A second objective is to characterize current outpatient arm therapy (dosage & content) following stroke for individuals who are eligible for ICARE. Eligible candidates must have had a stroke affecting an arm within the last 106 days.

Detailed Description
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Of the 700,000 individuals who experience a new or recurrent stroke each year, a majority have considerable residual disability. Sixty-five percent (65%) of patients at 6 months are unable to incorporate the paretic hand effectively into daily activities. In turn, this degree of functional deficit contributes to a reduced quality of life after stroke. The extent of disability has been underplayed by the use of the Barthel Index that captures only basic activities of daily living such as self-care and does not extend to activities and participation at higher levels of functioning that are most affected by a residual upper extremity disability. The past decade has witnessed an explosion of different therapy interventions designed to capitalize on the brain's inherent capability to rewire and learn well into old age and more importantly for rehabilitation, after injury. The most effective arm-focused interventions with the strongest evidence and potentially the most immediate and cost-effective appeal for the current health-care environment share a common emphasis on focused task-specific training applied with an intensity higher than usual care. Therefore, our primary aim is to compare the efficacy of a fully defined, hybrid combination of the most effective interventions (forced-use/constraint-induced therapy and skill-based/impairment-mitigating motor learning training), the Accelerated Skill Acquisition Program (ASAP), to an equivalent dose of usual and customary outpatient therapy.

Official Title
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Interdisciplinary Comprehensive Arm Rehab Evaluation (ICARE) Stroke Initiative

Conditions
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Stroke, Brain Infarction, Brain Ischemia, Cerebral Infarction, Cerebrovascular Disorders

Intervention / Treatment
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* Behavioral: Accelerated Skill Acquisition Program (ASAP)
* Behavioral: Dose-Equivalent Usual & Customary Care - DEUCC
* Behavioral: Usual and Customary Care - UCC


Participation Criteria
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Eligibility Criteria
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INCLUSION Ischemic or hemorrhagic stroke. Hemiparesis in an upper extremity. Age 21+. Able to communicate in English (or Spanish,Rancho Los Amigos site only). Willing to attend outpatient therapy & f/u evaluations for 1 yr. Some active finger extension. EXCLUSION Traumatic or non-vascular brain injury, subarachnoid hemorrhage, AV malformation. History of psychiatric illness requiring hospitalization within past 24 mos. Active drug treatment for dementia. Neurologic condition that may affect motor response (e.g. Parkinson's, ALS, MS). History of head trauma requiring >48 hours of hospitalization within past 12 mos. Amputation of all fingers or thumb of hemiparetic (weak) arm. Treated with Botox in affected arm within last 3 months.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASAP<br>A focused, intense, evidence-based, upper extremity rehabilitation program, administered during the early post-acute outpatient interval. The training intervention is based on the fundamental elements of skill acquisition through task-specific practice, impairment mitigation to increase capacity, and motivational enhancements to build self-confidence. | Behavioral: Accelerated Skill Acquisition Program (ASAP)<br>* A 30-hour dose is administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session precedes the first visit.<br>* Other names: ASAP;|
| Active Comparator: DEUCC<br>Dose-equivalent usual and customary arm therapy administered early post-acutely in the outpatient setting. This is a 30-hour dose equivalency group, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. | Behavioral: Dose-Equivalent Usual & Customary Care - DEUCC<br>* Usual and customary arm therapy administered early post-acutely in the outpatient setting, adjusted for dose, but otherwise administered in accordance with usual and customary practices. This is a 30-hour dose equivalency group, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration.<br>* Other names: DEUCC;|
| Other: UCC<br>Usual and customary arm therapy administered early post-acutely in the outpatient setting. This is an observation only group with treatment dose administered in accordance with usual and customary practices. | Behavioral: Usual and Customary Care - UCC<br>* Usual and customary arm therapy administered early post-acutely in the outpatient setting. This is an observation only group and treatment dose will be administered in accordance with usual and customary practices.<br>* Other names: UCC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wolf Motor Function Test (WMFT) Log-transformed Time | Change from baseline to end-of-study (12 months post-randomization) in log-transformed time required to perform each of the 15 standardized tasks with each upper extremity. | Baseline to 1 year post-randomization | 
| Wolf Motor Function Test Time | Change from baseline to end-of-study (12 months post-randomization) in time required to perform each of the 15 standardized tasks with each upper extremity. | Baseline to 1 year post-randomization | 
| Stroke Impact Scale (SIS) Hand Function Subscale Score. | Change from baseline to end-of-study (one year post-randomization). Range: 0-100; positive values reflect an improvement. Higher values indicate better perception of hand function. | Baseline to 1 year post-randomization | 
| Stroke Impact Scale (SIS), Hand Function Subscale, Percentage of Participants That Improved at Least 25 Points From Baseline to End-of-study (One Year Post-randomization) | The available range for improvement is from 0-100; thus participants with a baseline SIS score greater than 75 (n=15) were excluded from these analyses. | Baseline to 1 year post-randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wolf Motor Function Test (WMFT) Functional Ability Scale (FAS) | Assesses movement quality via digital media review of task performance post hoc, rated on a 6-point ordinal scale. | Baseline to 1 year post-randomization | 
| Stroke Impact Scale (SIS) Mobility Subscale Score. | Change from baseline to end-of-study (one year post-randomization). Range: 0-100; positive values reflect an improvement. Higher values indicate better perception of mobility. | Baseline to 1 year post-randomization | 
| Stroke Impact Scale (SIS) ADL/IADL Subscale Score. | Change from baseline to end-of-study (one year post-randomization). Range: 0-100; positive values reflect an improvement. Higher values indicate better perception of ease with activities queried. | Baseline to 1 year post-randomization | 
| National Institute of Health Stroke Scale (NIHSS) | Change from baseline to end-of-study (12 months post-randomization) in National Institute of Health Stroke Scale (NIHSS). Range 0-2. Lower scores indicate less stroke severity. | Baseline to 1 year post-randomization | 
| Wolf Motor Function Test (WMFT) Strength Component, Task #7 Weight to Box | Wolf Motor Function Test (WMFT) strength component, Task #7 Weight to Box, measured in pounds. | Baseline to 1 year post-randomization | 
| Wolf Motor Function Test (WMFT) Strength Component, Task #14 Grip Strength | Wolf Motor Function Test (WMFT) strength component, Task #14 Grip strength, measured in kilograms, change from baseline to one year post-randomization. | Baseline to 1 year post-randomization | 
| Arm Muscle Torque Test - Elbow Extensors | Change from baseline to end-of-study (12 months post-randomization) in isometric torque generated as measured in kilograms using a hand held Lafayette manual muscle test dynamometer and standard testing positions.Positive values indicate a strength gain. | Baseline to 1 year post-randomization | 
| Arm Muscle Torque Test - Elbow Flexors | Change from baseline to end-of-study (12 months post-randomization) in isometric torque generated as measured in kilograms using a hand held Lafayette manual muscle test dynamometer and standard testing positions. Positive values indicate a strength gain. | Baseline to 1 year post-randomization | 
| Arm Muscle Torque Test - Shoulder Extensors | Change from baseline to end-of-study (12 months post-randomization) in isometric torque generated as measured in kilograms using a hand held Lafayette manual muscle test dynamometer and standard testing positions. Positive values indicate a strength gain. | Baseline to 1 year post-randomization | 
| Arm Muscle Torque Test - Shoulder Flexors | Change from baseline to end-of-study (12 months post-randomization) in isometric torque generated as measured in kilograms using a hand held Lafayette manual muscle test dynamometer and standard testing positions. Positive values indicate a strength gain. | Baseline to 1 year post-randomization | 
| Arm Muscle Torque Test - Wrist Extensors | Change from baseline to end-of-study (12 months post-randomization) in isometric torque generated as measured in kilograms using a hand held Lafayette manual muscle test dynamometer and standard testing positions. Positive values indicate a strength gain. | Baseline to 1 year post-randomization | 
| Arm Muscle Torque Test - Wrist Flexors | Change from baseline to end-of-study (12 months post-randomization) in isometric torque generated as measured in kilograms using a hand held Lafayette manual muscle test dynamometer and standard testing positions. Positive values indicate a strength gain. | Baseline to 1 year post-randomization | 
| As-Tex Sensory Index |  | Baseline to 1 year post-randomization | 
| Upper Extremity Fugl Meyer (UEFM), Motor Component |  | Baseline to 1 year post-randomization | 
| D-KEFS Verbal Fluency Test |  | Baseline to 1 year post-randomization | 
| Digits Span Backward |  | Baseline to 1 year post-randomization | 
| Hopkins Verbal Learning Test, Revised (HVLT-R) |  | Baseline to 1 year post-randomization | 
| Color Trails Making Tests 1 & 2 |  | Baseline to 1 year post-randomization | 
| Short Blessed Memory Test |  | Baseline to 1 year post-randomization | 
| Patient Health Questionnaire 9 (PHQ-9) |  | Baseline to 1 year post-randomization | 
| Confidence in Arm & Hand Movement (CAHM) |  | Baseline to 1 year post-randomization | 
| Stroke Impact Scale (SIS) Communication Subscale Score. | Change from baseline to end-of-study (one year post-randomization). Range: 0-100; positive values reflect an improvement. Higher values indicate better perceptions of ability to communicate and comprehend. | Baseline to 1 year post-randomization | 
| Stroke Impact Scale (SIS) Emotion Subscale Score. | Change from baseline to end-of-study (one year post-randomization). Range: 0-100; positive values reflect an improvement. Higher values indicate better perceptions of mood and emotional control. | Baseline to 1 year post-randomization | 
| Motor Activity Log 28 QOM (MAL-28) |  | Baseline to 1 year post-randomization | 
| EQ5D |  | Baseline to 1 year post-randomization | 
| Satisfaction With Life Scale (SWLS) |  | Baseline to 1 year post-randomization | 
| Single-Item Subjective Quality of Life Measurement (SQOL) |  | Baseline to 1 year post-randomization | 
| Reintegration to Normal Living Index (RNLI) |  | Baseline to 1 year post-randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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motor control, stroke, hemiparesis, physical therapy, occupational therapy, neurorehabilitation, patient focused, motor learning, skill acquisition, skill training, motor recovery, task oriented training, task specific training, arm function, hand function, upper extremity, arm therapy, physical rehabilitation, arm rehabilitation, motor function