Recruiting
Phase 2

Constraint-Based Therapy

Sponsor:

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

Code:

NCT00061139

Conditions

Cerebral Palsy

Motor Deficits

Eligibility Criteria

Sex: All

Age: 2 - 6

Healthy Volunteers: Not accepted

Interventions

Pediatric Constraint-Induced Movement therapy

Conventional pediatric motor rehabilitation therapy

Study Details

Brief 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.

Conditions

Cerebral Palsy

Motor Deficits

Study ID

NCT00061139

Start date

Sep, 2002

Status verified date

Apr, 2003

Completion date

Sep, 2006

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 6

Healthy Volunteers: Not accepted

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

Enrollment

52 participants

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Pediatric Constraint-Induced Movement therapy

Conventional pediatric motor rehabilitation therapy

Central Contacts and Locations

Central contacts

Edward Taub, PhD

205-934-2471etaub@uab.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Edward Taub, PhD

205-934-2471etaub@uab.edu

Principal Investigator:

Edward Taub, PhD

More Information

Sponsor

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

Last update posted

Jun 24, 2005

Last verified

Apr, 2003

Keywords

  • Cerebral palsy
  • Hemiparesis
  • Pediatric CI therapy
  • Upper extremity
  • Training
  • Limb restraint

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) on 2005-06-24.