Home-Based Automated Therapy of Arm Function After Stroke Via Tele-Rehabilitation

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Behavioral: Tele-AutoCITE; Behavioral: CI therapy

• Registration Number: NCT01157195
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-17
• Study First Submitted QC: 2010-07-02
• Study First Posted: 2010-07-05
• Primary Completion: 2013-08
• Study Completion: 2018-08
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-26
• Last Update Posted: 2018-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tele-AutoCITE	Tele-AutoCITE	AutoCITE stands for Automated Constraint Induced Therapy Extender.
CI therapy	CI therapy	-

Primary Outcome Measures

Name	Time	Method
Change in Motor Activity Log (MAL) Arm Use Scale at 2 weeks	Baseline to 2 weeks (average)	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.

Secondary Outcome Measures

Name	Time	Method
Change in Wolf Motor Function Test (WMFT) Performance Rate at 2 weeks	Baseline to 2 weeks (average)	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 12 months	Baseline to 12 months (average)	See primary outcome.
Change in MAL Arm Use Scale at 6 months	Baseline to 6 months (average)	See primary outcome.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States