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

This study is currently recruiting participants.
Verified by National Institute of Child Health and Human Development (NICHD), April 2003

Sponsored by: National Institute of Child Health and Human Development (NICHD)
Information provided by: National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00061139
  Purpose

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.


Condition Intervention Phase
Cerebral Palsy
Motor Deficits
Behavioral: Pediatric Constraint-Induced Movement therapy
Behavioral: Conventional pediatric motor rehabilitation therapy
Phase II

MedlinePlus related topics:   Cerebral Palsy    Paralysis    Rehabilitation   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind, Active Control, Factorial Assignment, Efficacy Study
Official Title:   Randomized Controlled Trial of Pediatric CI Therapy

Further study details as provided by National Institute of Child Health and Human Development (NICHD):

Estimated Enrollment:   52
Study Start Date:   September 2002
Estimated Study Completion Date:   September 2006

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).

  Eligibility
Ages Eligible for Study:   2 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00061139

Contacts
Contact: Edward Taub, PhD     205-934-2471     etaub@uab.edu    

Locations
United States, Alabama
University of Alabama at Birmingham     Recruiting
      Birmingham, Alabama, United States, 35294
      Contact: Edward Taub, PhD     205-934-2471     etaub@uab.edu    
      Principal Investigator: Edward Taub, PhD            

Sponsors and Collaborators

Investigators
Principal Investigator:     Edward Taub, PhD     University of Alabama at Birmingham    
  More Information

Study ID Numbers:   R01HD40692
First Received:   May 21, 2003
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00061139
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Child Health and Human Development (NICHD):
Cerebral palsy  
Hemiparesis  
Pediatric CI therapy  
Upper extremity
Training
Limb restraint

Study placed in the following topic categories:
Paralysis
Cerebral Palsy
Brain Damage, Chronic
Central Nervous System Diseases
Brain Diseases
Brain Injuries

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on August 28, 2008




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