- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01157195
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35294
- University of Alabama at Birmingham
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- more than 1 year after stroke
- some ability to voluntarily open fingers on more affected side of body
- some ability to voluntarily raise wrist on more affected side of body
- ability to stand independently for two minutes
- ability to transfer from sit to stand independently
Exclusion Criteria:
- serious, concurrent medical conditions including frailty
- excessive spasticity (high muscle tone) in more affected arm
- impairment in thinking that makes compliance with study activities difficult
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: CI therapy
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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.
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Experimental: Tele-AutoCITE
AutoCITE stands for Automated Constraint Induced Therapy Extender.
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Automated, remotely-administered form of CI therapy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Motor Activity Log (MAL) Arm Use Scale at 2 weeks
Time Frame: Baseline to 2 weeks (average)
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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.
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Baseline to 2 weeks (average)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Wolf Motor Function Test (WMFT) Performance Rate at 2 weeks
Time Frame: Baseline to 2 weeks (average)
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Well-validated laboratory motor performance test that assesses how quickly an individual can perform upper-extremity tasks with the more-affected arm after stroke.
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Baseline to 2 weeks (average)
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Change in MAL Arm Use Scale at 6 months
Time Frame: Baseline to 6 months (average)
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See primary outcome.
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Baseline to 6 months (average)
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Change in MAL Arm Use Scale at 12 months
Time Frame: Baseline to 12 months (average)
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See primary outcome.
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Baseline to 12 months (average)
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Gitendra Uswatte, PhD, Psychology Department, University of Alabama at Birmingham
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- F071227003
- R01HD053750 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on CI therapy
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Ohio State UniversityUniversity of Missouri-Columbia; University of Alabama at Birmingham; University... and other collaboratorsCompletedEffectiveness of Virtual Reality Gaming Therapy Versus CI Therapy for Upper Extremity RehabilitationStroke | HemiparesisUnited States
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Ohio State UniversityActive, not recruitingStroke | HemiparesisUnited States
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University of Massachusetts, LowellOhio State UniversityCompletedHemiparesis | Primary Progressive Multiple SclerosisUnited States
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National Multiple Sclerosis SocietyCompletedMultiple SclerosisUnited States
-
University of Alabama at BirminghamCompleted
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University of Alabama at BirminghamRecruitingStroke | Upper Extremity Paresis | CVA (Cerebrovascular Accident)United States
-
University of Missouri-ColumbiaCompletedAutism Spectrum Disorder | Chronic InsomniaUnited States
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University of Alabama at BirminghamRecruitingStroke | Upper Extremity Paresis | CVA (Cerebrovascular Accident)United States
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University of Alabama at BirminghamCompletedChronic Stroke Survivors With Plegic HandUnited States
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National Multiple Sclerosis SocietyUnknown