- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00061139
Constraint-Based Therapy to Improve Motor Function in Children With Cerebral Palsy
Randomized Controlled Trial of Pediatric CI Therapy
Study Overview
Status
Conditions
Detailed Description
Cerebral palsy afflicts at least two in 1,000 children in the United States and approximately 2,000,000 children worldwide. Behavioral techniques that impact the plasticity of the nervous system need to be incorporated into practical, evidence-based therapeutic interventions for this condition.
CI therapy was derived from basic research with animal and human subjects. Randomized, controlled studies indicate that it can substantially reduce the motor deficit of adult patients with mild to moderately severe chronic strokes and can increase their independence over a period of years. CI therapy involves motor restriction of the less affected upper extremity for a period of 2 to 3 weeks while concurrently training the more affected upper limb. This gives rise to concentrated, repetitive use of the more affected extremity. In adults, CI therapy has lead to a large increase in use-dependent cortical reorganization involving the recruitment of substantial new regions of the brain in the innervation of more affected extremity movement.
The study will evaluate CI therapy in a pediatric population. The study will test whether pediatric CI therapy can promote new and improved motor behavior in young children with hemiparesis associated with cerebral palsy. Pediatric CI therapy involves total restraint of the unaffected upper extremity with simultaneous repetitive use of the affected extremity for 6 hours/day for 21 consecutive days.
Fifty-two children ages 2 to 6 years old with hemiparetic cerebral palsy will be randomly assigned to either the pediatric CI therapy group or to a control group. The control group will receive standard rehabilitation therapy. All children will have a complete medical evaluation with emphasis on motor function prior to treatment initiation. Children will undergo follow-up testing at 1, 6, and 12 months post-treatment. The primary study assessment tools are the Pediatric Developmental Motor Scales - II (PDMS-II), DASI - II, Bayley Developmental Skills Test, Pediatric Motor Activity Log (PMAL), Child Arm Use Test (CAUT), and Emerging Behavior Scale (EBS).
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Edward Taub, PhD
- Phone Number: 205-934-2471
- Email: etaub@uab.edu
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35294
- Recruiting
- University of Alabama at Birmingham
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Contact:
- Edward Taub, PhD
- Phone Number: 205-934-2471
- Email: etaub@uab.edu
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Principal Investigator:
- Edward Taub, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
- Clinical diagnosis of hemiparetic cerebral palsy consistent with criteria in Swaiman and Russman (1999) and Badawi et al. (1998)
- Recommended for participation in pediatric rehabilitation and/or early intervention
- Lives within 50 miles of the Civitan Center at University of Alabama at Birmingham or the family is willing to temporarily relocate to the Birmingham area for treatment
Exclusion Criteria
- Profound bilateral hearing loss with the use of hearing aids
- Severe visual impairment
- Serious seizure disorder or uncontrolled seizures
- Genetic and syndromic conditions historically excluded for CP registries
- Familial Spastic Paraplegia
- Ataxic Cerebral Palsy
- Diagnosis of Pervasive Developmental Disability or autism
- Serious or recurring medical complications
- Scheduled for surgery within 12 months of study entry
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Collaborators and Investigators
Investigators
- Principal Investigator: Edward Taub, PhD, University of Alabama at Birmingham
Study record dates
Study Major Dates
Study Start
Primary Completion
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01HD040692 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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