This trial is active, not recruiting.

Condition stroke
Treatments tele-autocite, ci therapy
Sponsor University of Alabama at Birmingham
Collaborator Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Start date June 2010
End date August 2013
Trial size 25 participants
Trial identifier NCT01157195, F071227003, R01HD053750


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification bio-equivalence study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
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.
AutoCITE stands for Automated Constraint Induced Therapy Extender.
Automated, remotely-administered form of CI therapy

Primary Outcomes

Change in Motor Activity Log (MAL) Arm Use Scale at 2 weeks
time frame: Baseline to 2 weeks (average)

Secondary Outcomes

Change in Wolf Motor Function Test (WMFT) Performance Rate at 2 weeks
time frame: Baseline to 2 weeks (average)
Change in MAL Arm Use Scale at 6 months
time frame: Baseline to 6 months (average)
Change in MAL Arm Use Scale at 12 months
time frame: Baseline to 12 months (average)

Eligibility Criteria

Male or female participants at least 19 years old.

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

Additional Information

Official title Home-Based Automated Therapy of Arm Function After Stroke Via Tele-Rehabilitation
Principal investigator Gitendra Uswatte, PhD
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by University of Alabama at Birmingham.