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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00061139
Other study ID # R01HD040692
Secondary ID
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
Est. primary completion date
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


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, 

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