The Baby CHAMP Study (Children With Hemiparesis Arm and Movement Project) (NCT02346825) | Clinical Trial Compass
CompletedPhase 1/2
The Baby CHAMP Study (Children With Hemiparesis Arm and Movement Project)
United States58 participantsStarted 2015-01
Plain-language 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.
Who can participate
Age range
6 Months – 24 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in the Mini - Assisting Hand Assessment
Timeframe: immediatly prior to treatment, immediately after treatment, 6 months after treatment, 12 months after treatment
2
Change in the Bayley Infant Scales of Development
Timeframe: immediatly prior to treatment, immediately after treatment, 6 months after treatment, 12 months after treatment
Trial details
NCT IDNCT02346825
SponsorVirginia Polytechnic Institute and State University