NCT00061139

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2002

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 22, 2003

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

June 24, 2005

Status Verified

April 1, 2003

First QC Date

May 21, 2003

Last Update Submit

June 23, 2005

Conditions

Cerebral PalsyMotor Deficits

Keywords

Cerebral palsyHemiparesisPediatric CI therapyUpper extremityTrainingLimb restraint

Interventions

Pediatric Constraint-Induced Movement therapyBEHAVIORAL
Conventional pediatric motor rehabilitation therapyBEHAVIORAL

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

MeSH Terms

Conditions

Cerebral PalsyNeurologic ManifestationsParesis

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Edward Taub, PhD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Edward Taub, PhD

CONTACT

205-934-2471etaub@uab.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
NIH

Study Record Dates

First Submitted

May 21, 2003

First Posted

May 22, 2003

Study Start

September 1, 2002

Study Completion

September 1, 2006

Last Updated

June 24, 2005

Record last verified: 2003-04

Locations

US(1)