Constraint-Based Therapy to Improve Motor Function in Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

Randomized Controlled Trial of Pediatric CI Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00061139
• Other study ID #: R01HD040692
• Status: Recruiting
• Phase: Phase 2
• First received: May 21, 2003
• Last updated: June 23, 2005
• Start date: September 2002
• Est. completion date: September 2006

Study information

• Verified date: April 2003
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: Edward Taub, PhD
• Phone: 205-934-2471
• Email: etaub[@]uab.edu
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Pediatric Constraint-Induced (CI) Movement therapy is a rehabilitation program designed to improve motor function in children with partial paralysis. Children with cerebral palsy may have one arm that has significantly greater function (good arm) than the other (bad arm). Restricting the use of the good arm may improve the use of the bad arm. In pediatric CI therapy, the good arm is put in a sling to force increased use of the bad arm. The bad arm is also trained each day for several weeks. This study will test the ability of pediatric CI therapy to improve motor function in children with cerebral palsy.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 6 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy
• Motor Deficits

Intervention

Behavioral:
• Pediatric Constraint-Induced Movement therapy

• Conventional pediatric motor rehabilitation therapy

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

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

Country where clinical trial is conducted

United States,