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

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ClinicalTrials.gov Identifier: NCT00061139
Recruitment Status : Unknown
Verified April 2003 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was:  Recruiting
First Posted : May 22, 2003
Last Update Posted : June 24, 2005
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Motor Deficits Behavioral: Pediatric Constraint-Induced Movement therapy Behavioral: Conventional pediatric motor rehabilitation therapy Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Pediatric CI Therapy
Study Start Date : September 2002
Estimated Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00061139

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

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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Edward Taub, PhD University of Alabama at Birmingham
More Information

ClinicalTrials.gov Identifier: NCT00061139     History of Changes
Other Study ID Numbers: R01HD040692 ( U.S. NIH Grant/Contract )
First Posted: May 22, 2003    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: April 2003

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

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases