Baby CHAMP (Children's Hand Arm Movement Project)

  • STATUS
    Recruiting
  • sponsor
    NICHD
Updated on 8 November 2020

Summary

Baby CHAMP (Children's Hand Arm Movement Project)

Description

The Baby Champ Study, a clinical trial funded by the National Institutes of Health, compares three highly promising forms of therapy for infants and toddlers who have a diagnosis of hemiparetic cerebral palsy.

Children who meet study eligibility criteria will participate at one of the two clinical sites:

Roanoke, Virginia, or Columbus, Ohio.

Families do not have to live in those areas but must be willing to travel to participate in all assessments and the 1-month period when daily intensive therapy (3 hrs each week day for 4 weeks) will be provided. Children will be randomly assigned to one of three alternative therapy conditions all of which have shown the ability to help children gain increased functional skills. Participation in the study includes assessment of each child prior to and 3 times after treatment; immediately following treatment, and at 6 and 12 months later.

All the therapies in this study include parents as partners with the trained therapist in order to maximize practice and improvement in the child’s functional abilities in everyday settings.

There is no charge for the therapy provided, but travel is at the families expense.

Details
Condition Cerebral Palsy (Pediatric)
Clinical Study IdentifierTX146133
SponsorNICHD
Last Modified on8 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Your child may be eligible to participate in the study if he or she
Is between 6 and 24 months old
Has a medical diagnosis of cerebral palsy
Has significant impairment in the use of an upper extremity
Can communicate basic needs and interact in a playful way with a familiar adult; and
Has one or both parents who are willing to participate in learning how to provide at-home therapy activities that will involve one hour a day over a four week period
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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