Clinical trial NCT01157195: Home-Based Automated Therapy of Arm Function After Stroke Via Tele-Rehabilitation
Official title: Home-Based Automated Therapy of Arm Function After Stroke Via Tele-Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
chronic
arm
rehabilitation
tele-health
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2010-07-05
Enrollment: 25
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Motor Activity Log (MAL) Arm Use Scale at 2 weeks
timeFrame: Baseline to 2 weeks (average)
Secondary outcomes:
measure: Change in Wolf Motor Function Test (WMFT) Performance Rate at 2 weeks
timeFrame: Baseline to 2 weeks (average)
measure: Change in MAL Arm Use Scale at 6 months
timeFrame: Baseline to 6 months (average)
measure: Change in MAL Arm Use Scale at 12 months
timeFrame: Baseline to 12 months (average)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: Psychology Department, University of Alabama at Birmingham
name: Gitendra Uswatte, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.