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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
361
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.
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.
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.
University of Southern California
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Rancho Los Amigos National Rehabilitation Center
Los Angeles, California, United States
Long Beach Memorial Medical Center
Los Angeles, California, United States
Huntington Rehabilitation Medicine Associates
Los Angeles, California, United States
Casa Colina Centers for Rehabilitation
Los Angeles, California, United States
National Rehabilitation Hospital
Washington D.C., District of Columbia, United States
Emory University
Atlanta, Georgia, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 1 year post-randomization
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 1 year post-randomization
As-Tex Sensory Index
Time frame: Baseline to 1 year post-randomization
Upper Extremity Fugl Meyer (UEFM), Motor Component
Time frame: Baseline to 1 year post-randomization
D-KEFS Verbal Fluency Test
Time frame: Baseline to 1 year post-randomization
Digits Span Backward
Time frame: Baseline to 1 year post-randomization
Hopkins Verbal Learning Test, Revised (HVLT-R)
Time frame: Baseline to 1 year post-randomization
Color Trails Making Tests 1 & 2
Time frame: Baseline to 1 year post-randomization
Short Blessed Memory Test
Time frame: Baseline to 1 year post-randomization
Patient Health Questionnaire 9 (PHQ-9)
Time frame: Baseline to 1 year post-randomization
Confidence in Arm & Hand Movement (CAHM)
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 1 year post-randomization
Motor Activity Log 28 QOM (MAL-28)
Time frame: Baseline to 1 year post-randomization
EQ5D
Time frame: Baseline to 1 year post-randomization
Satisfaction With Life Scale (SWLS)
Time frame: Baseline to 1 year post-randomization
Single-Item Subjective Quality of Life Measurement (SQOL)
Time frame: Baseline to 1 year post-randomization
Reintegration to Normal Living Index (RNLI)
Time frame: Baseline to 1 year post-randomization
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