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

Primary Purpose

Cerebral Palsy, Motor Deficits

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pediatric Constraint-Induced Movement therapy
Conventional pediatric motor rehabilitation therapy
Sponsored by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Cerebral palsy, Hemiparesis, Pediatric CI therapy, Upper extremity, Training, Limb restraint

Eligibility Criteria

2 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at BirminghamRecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 21, 2003
Last Updated
June 23, 2005
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT00061139
Brief Title
Constraint-Based Therapy to Improve Motor Function in Children With Cerebral Palsy
Official Title
Randomized Controlled Trial of Pediatric CI Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2003
Overall Recruitment Status
Unknown status
Study Start Date
September 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (undefined)

3. Sponsor/Collaborators

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

4. Oversight

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Motor Deficits
Keywords
Cerebral palsy, Hemiparesis, Pediatric CI therapy, Upper extremity, Training, Limb restraint

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
Single
Allocation
Randomized
Enrollment
52 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Pediatric Constraint-Induced Movement therapy
Intervention Type
Behavioral
Intervention Name(s)
Conventional pediatric motor rehabilitation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Edward Taub, PhD
Phone
205-934-2471
Email
etaub@uab.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward Taub, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edward Taub, PhD
Phone
205-934-2471
Email
etaub@uab.edu
First Name & Middle Initial & Last Name & Degree
Edward Taub, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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