Arm Rehabilitation Study After Stroke

Not Applicable

Completed

• Conditions: Stroke; Brain Infarction; Cerebral Infarction; Brain Ischemia; Cerebrovascular Disorders

• Registration Number: NCT00871715
• Lead Sponsor: University of Southern California

Brief Summary

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

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 Timeline

• Study First Submitted: 2009-03-27
• Study First Submitted QC: 2009-03-27
• Study First Posted: 2009-03-30
• Study Start: 2009-06
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Results First Submitted: 2016-02-17
• Results First Submitted QC: 2016-03-23
• Results First Posted: 2016-04-27
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-14
• Last Update Posted: 2019-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 361

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Stroke Impact Scale (SIS) Hand Function Subscale Score.	Baseline to 1 year post-randomization	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.
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)	Baseline to 1 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.
Wolf Motor Function Test (WMFT) Log-transformed Time	Baseline to 1 year post-randomization	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.
Wolf Motor Function Test Time	Baseline to 1 year post-randomization	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.

Secondary Outcome Measures

Name	Time	Method
D-KEFS Verbal Fluency Test	Baseline to 1 year post-randomization
Wolf Motor Function Test (WMFT) Functional Ability Scale (FAS)	Baseline to 1 year post-randomization	Assesses movement quality via digital media review of task performance post hoc, rated on a 6-point ordinal scale.
National Institute of Health Stroke Scale (NIHSS)	Baseline to 1 year post-randomization	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.
Wolf Motor Function Test (WMFT) Strength Component, Task #14 Grip Strength	Baseline to 1 year post-randomization	Wolf Motor Function Test (WMFT) strength component, Task #14 Grip strength, measured in kilograms, change from baseline to one year post-randomization.
Arm Muscle Torque Test - Shoulder Flexors	Baseline to 1 year post-randomization	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.
Arm Muscle Torque Test - Elbow Flexors	Baseline to 1 year post-randomization	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.
Arm Muscle Torque Test - Shoulder Extensors	Baseline to 1 year post-randomization	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.
As-Tex Sensory Index	Baseline to 1 year post-randomization
Stroke Impact Scale (SIS) ADL/IADL Subscale Score.	Baseline to 1 year post-randomization	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.
Stroke Impact Scale (SIS) Mobility Subscale Score.	Baseline to 1 year post-randomization	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.
Arm Muscle Torque Test - Wrist Flexors	Baseline to 1 year post-randomization	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.
Wolf Motor Function Test (WMFT) Strength Component, Task #7 Weight to Box	Baseline to 1 year post-randomization	Wolf Motor Function Test (WMFT) strength component, Task #7 Weight to Box, measured in pounds.
Arm Muscle Torque Test - Wrist Extensors	Baseline to 1 year post-randomization	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.
Upper Extremity Fugl Meyer (UEFM), Motor Component	Baseline to 1 year post-randomization
Arm Muscle Torque Test - Elbow Extensors	Baseline to 1 year post-randomization	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.
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
Confidence in Arm & Hand Movement (CAHM)	Baseline to 1 year post-randomization
Motor Activity Log 28 QOM (MAL-28)	Baseline to 1 year post-randomization
Satisfaction With Life Scale (SWLS)	Baseline to 1 year post-randomization
Stroke Impact Scale (SIS) Communication Subscale Score.	Baseline to 1 year post-randomization	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.
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
Stroke Impact Scale (SIS) Emotion Subscale Score.	Baseline to 1 year post-randomization	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.
EQ5D	Baseline to 1 year post-randomization
Patient Health Questionnaire 9 (PHQ-9)	Baseline to 1 year post-randomization

Trial Locations

Locations (8)

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, District of Columbia, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States