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

Completed · Phase 1/Phase 2

Conditions studied: Hemiparesis, Cerebral Palsy

In brief

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.

Key facts

Study ID

NCT02346825

Run by

Virginia Polytechnic Institute and State University

People needed

58

Starts

2015-01-01

Expected to finish

2019-12-01

Last updated by the study team

2022-03-11

Who can join

Age: 1 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• child is 6 - 24 months old
• diagnosis of unilateral/asymmetrical Cerebral Palsy
• has functional upper extremity impairment levels of II, III, or IV (Manual Abilities Classification System, Eliasson et al 2006)
• parent(s) willing to be partners in study and participate in follow-up assessments for 12 mos.

You may not qualify if…

• medical or sensory condition that prevents full therapy participation (e.g., frequent uncontrolled seizures, blindness)
• received CIMT or had botulinum toxin therapy in past 6 mos.

Where it is running

• The Ohio State University — Columbus, Ohio, United States
• University of Virginia — Charlottesville, Virginia, United States
• Fralin Biomedical Research Institute at Virginia Tech — Roanoke, Virginia, United States

Full record on ClinicalTrials.gov

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