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

The University of Alabama at Birmingham

Status: Completed

Conditions: Stroke

Treatments: Behavioral: CI therapy; Behavioral: Tele-AutoCITE

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01157195

R01HD053750 (U.S. NIH Grant/Contract)

F071227003

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

CI therapy

Active Comparator group

Treatment:

Behavioral: CI therapy

Tele-AutoCITE

Experimental group

Description:

AutoCITE stands for Automated Constraint Induced Therapy Extender.

Treatment:

Behavioral: Tele-AutoCITE