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

NCT ID: NCT01157195

Last Updated: 2018-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2018-08-31

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CI therapy

Group Type: ACTIVE_COMPARATOR

CI therapy

Intervention Type: BEHAVIORAL

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.

Tele-AutoCITE

AutoCITE stands for Automated Constraint Induced Therapy Extender.

Group Type: EXPERIMENTAL

Tele-AutoCITE

Intervention Type: BEHAVIORAL

Automated, remotely-administered form of CI therapy

Interventions

Tele-AutoCITE

Automated, remotely-administered form of CI therapy

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Gitendra Uswatte

Associate Professor of Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gitendra Uswatte, PhD

Role: PRINCIPAL_INVESTIGATOR

Psychology Department, University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

References

Taub E, Uswatte G, Pidikiti R. Constraint-Induced Movement Therapy: a new family of techniques with broad application to physical rehabilitation--a clinical review. J Rehabil Res Dev. 1999 Jul;36(3):237-51.

Reference Type: BACKGROUND

PMID: 10659807 (View on PubMed)

Other Identifiers

R01HD053750

Identifier Type: NIH

Identifier Source: secondary_id

View Link

F071227003

Identifier Type: -

Identifier Source: org_study_id