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The Baby CHAMP Study (Children With Hemiparesis Arm and Movement Project)

NCT02346825 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2022-03-11

No results posted yet for this study

Summary

The Baby CHAMP Study is a multisite clinical trial funded by the National Institutes of Health that is examining the the use of constraint-induced movement therapy (CIMT) for infants and toddlers as a effective treatment, since there have been no randomized control trials (RCT) for the age range as well as monitor the stress levels as related by self-report of parents or biological indicators. Infants and toddlers who meet study eligibility requirements at one of the three clinical sites (Charlottesville, VA, Columbus, OH, and Roanoke, VA) will be invited to enroll, and their parents will be provided all necessary paperwork along with informational documentation.

Conditions

  • Hemiparesis
  • Cerebral Palsy

Interventions

BEHAVIORAL

Neurorehabilitation therapy with cast

Children in this group will have 3 hours of daily therapy each weekday for 4 weeks while wearing a full-arm cast on their stronger arm and hand. Parents will be required to do 45 minutes of daily therapy for which they will be trained.

BEHAVIORAL

Neurorehabilitation therapy with splint

Children in this group will have 3 hours of daily therapy each weekday for 4 weeks while wearing part-time splint on their stronger arm and hand. Parents will be required to do 45 minutes of daily therapy for which they will be trained.

BEHAVIORAL

Neurorehabilitation bimanual

Children in this group will have 3 hours of daily therapy each weekday for 4 weeks will not wear a constraint. Parents will be required to do 45 minutes of daily therapy for which they will be trained.

Sponsors & Collaborators

  • Ohio State University

    collaborator OTHER

  • University of Virginia

    collaborator OTHER

  • Virginia Polytechnic Institute and State University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
6 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2018-12-31
Completion
2019-12-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02346825 on ClinicalTrials.gov