Home-Based Automated Therapy of Arm Function After Stroke Via Tele-Rehabilitation
Constraint-Induced Movement therapy, also known as CI therapy, is an approach to physical rehabilitation derived from basic behavioral and neuroscience research. It has been shown to be efficacious for rehabilitating use of the more-affected arm in individuals more than one year after stroke with mild to moderate motor impairment. The first component of the therapy is intensive training in use of the more-affected arm on functional tasks for 3 hours daily for 10 consecutive weekdays. The second is wearing a protective safety mitt on the less-affected hand for all waking hours of the approximately 2-week treatment period that it is safe to do so. The purpose of the mitt is to discourage use of the less-affected arm. The third is a group of behavioral techniques designed to transfer gains from the treatment setting to the real world, which takes a therapist, on average, 30 minutes to implement on each treatment day.
The purpose of this project is to develop and test a method for automating the delivery of this efficacious treatment in a way that the therapy can be provided in stroke patients' homes. After developing an automated CI therapy workstation that has tele-health capabilities, the investigators will conduct a randomized controlled trial to evaluate whether CI therapy delivered in the home using this workstation with remote supervision by a therapist via an Internet-based audiovisual link provides outcomes that are just as good as CI therapy delivered by a "live" therapist.
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Home-Based Automated Therapy of Arm Function After Stroke Via Tele-Rehabilitation|
- Change in Motor Activity Log (MAL) Arm Use Scale at 2 weeks [ Time Frame: Baseline to 2 weeks (average) ] [ Designated as safety issue: No ]Well-validated structured interview that assesses how much and how well the more-affected arm after stroke has been used to accomplish everyday activities over a specified period.
- Change in Wolf Motor Function Test (WMFT) Performance Rate at 2 weeks [ Time Frame: Baseline to 2 weeks (average) ] [ Designated as safety issue: No ]Well-validated laboratory motor performance test that assesses how quickly an individual can perform upper-extremity tasks with the more-affected arm after stroke.
- Change in MAL Arm Use Scale at 6 months [ Time Frame: Baseline to 6 months (average) ] [ Designated as safety issue: No ]See primary outcome.
- Change in MAL Arm Use Scale at 12 months [ Time Frame: Baseline to 12 months (average) ] [ Designated as safety issue: No ]See primary outcome.
|Study Start Date:||June 2010|
|Estimated Study Completion Date:||August 2017|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
|Active Comparator: CI therapy||
Behavioral: CI therapy
CI therapy is a behavioral approach to physical rehabilitation that has three components: 1. intense training of the more affected arm for several hours daily for multiple consecutive days, 2. restraint of the less affected arm during training hours and afterwards during the treatment period, 3. A package of behavioral techniques designed to transfer gains from the treatment setting to daily life. In this trial, CI therapy will be administered for 3 1/2 hours per day for 10 consecutive weekdays.
AutoCITE stands for Automated Constraint Induced Therapy Extender.
Automated, remotely-administered form of CI therapy
Please refer to this study by its ClinicalTrials.gov identifier: NCT01157195
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
|Principal Investigator:||Gitendra Uswatte, PhD||Psychology Department, University of Alabama at Birmingham|