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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02346825
Recruitment Status : Completed
First Posted : January 27, 2015
Last Update Posted : October 6, 2020
Sponsor:
Collaborators:
Ohio State University
University of Virginia
Information provided by (Responsible Party):
Stephanie DeLuca, Virginia Polytechnic Institute and State University

Brief 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.

Condition or disease Intervention/treatment Phase
Hemiparesis Cerebral Palsy Behavioral: Neurorehabilitation therapy with cast Behavioral: Neurorehabilitation therapy with splint Behavioral: Neurorehabilitation bimanual Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multisite RCT of 3 Neurorehabilitation Therapies for Infants With Asymmetrical Cerebral Palsy
Study Start Date : January 2015
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cerebral Palsy

Arm Intervention/treatment
Experimental: Intensive Plus 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 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.
Other Names:
  • Pediatric Constraint-Induced Movement Therapy
  • P-CIMT

Experimental: Intensive Plus Splint
Children in this group will have 3 hours of daily therapy each weekday for 4 weeks while wearing a 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 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.
Other Names:
  • Pediatric Constraint-Induced Movement Therapy
  • P-CIMT

Experimental: Intensive no Constraint
Children in this group will have 3 hours of daily therapy each weekday for 4 weeks but will not wear a constraint. 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.
Other Names:
  • Bimanual
  • HABIT




Primary Outcome Measures :
  1. Change in the Mini - Assisting Hand Assessment [ Time Frame: immediatly prior to treatment, immediately after treatment, 6 months after treatment, 12 months after treatment ]
    functional assessment

  2. Change in the Bayley Infant Scales of Development [ Time Frame: immediatly prior to treatment, immediately after treatment, 6 months after treatment, 12 months after treatment ]
    functional assessment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02346825


Locations
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United States, Ohio
The Ohio State University
Columbus, Ohio, United States
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States
Virginia Tech Carilion Research Institute
Roanoke, Virginia, United States, 24016
Sponsors and Collaborators
Virginia Polytechnic Institute and State University
Ohio State University
University of Virginia
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Responsible Party: Stephanie DeLuca, Assistant Professor, Virginia Polytechnic Institute and State University
ClinicalTrials.gov Identifier: NCT02346825    
Other Study ID Numbers: 1R01HD074574-01A1 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2015    Key Record Dates
Last Update Posted: October 6, 2020
Last Verified: July 2019
Keywords provided by Stephanie DeLuca, Virginia Polytechnic Institute and State University:
P-CIMT
Pediatric Constraint Induced Movement Therapy
Hemiparesis
Cerebral Palsy
Infants
Toddlers
Children
Additional relevant MeSH terms:
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Cerebral Palsy
Paresis
Neurologic Manifestations
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases