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

NCT02346825 | Completed Phase 1

• 1 other identifier: 1R01HD074574-01A1
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 3

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.

Conditions

Hemiparesis; Cerebral Palsy

Keywords

P-CIMT; Pediatric Constraint Induced Movement Therapy; Hemiparesis; Cerebral Palsy; Infants; Toddlers; Children

Outcome Measures

Primary Outcomes (2)

• Change in the Mini - Assisting Hand Assessment

  functional assessment

  immediatly prior to treatment, immediately after treatment, 6 months after treatment, 12 months after treatment

• Change in the Bayley Infant Scales of Development

  functional assessment

  immediatly prior to treatment, immediately after treatment, 6 months after treatment, 12 months after treatment

Study Arms (3)

Intensive Plus Cast

EXPERIMENTAL

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

Intensive Plus Splint

EXPERIMENTAL

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

Intensive no Constraint

EXPERIMENTAL

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

Interventions

Neurorehabilitation therapy with cast BEHAVIORAL

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.

Also known as: Pediatric Constraint-Induced Movement Therapy, P-CIMT

Intensive Plus Cast

Neurorehabilitation therapy with splint BEHAVIORAL

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.

Also known as: Pediatric Constraint-Induced Movement Therapy, P-CIMT

Intensive Plus Splint

Neurorehabilitation bimanual BEHAVIORAL

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.

Also known as: Bimanual, HABIT

Intensive no Constraint

Eligibility Criteria

• Age: 6 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University: lead
• Ohio State University: collaborator
• University of Virginia: collaborator

Study Sites (3)

The Ohio State University

Columbus, Ohio, United States

Location

University of Virginia

Charlottesville, Virginia, United States

Location

Fralin Biomedical Research Institute at Virginia Tech

Roanoke, Virginia, 24016, United States

Location

MeSH Terms

Conditions

Paresis; Cerebral Palsy

Interventions

POLR1G protein, human; Splints

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 15, 2015
• First Posted: January 27, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: March 11, 2022

Record last verified: 2022-03

Locations

US (3)