CHAMP T 2 Pilot of CIMT by Tele-Video

NCT06486987 | Active Not Recruiting

• 1 other identifier: STUDY00004128
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

The CHAMP-T2 study is a pilot test of the efficacy of constraint induced movement therapy (CIMT) when delivered by tele-video in the child's home or home-like environment. This study will examine the pre-, post-intervention function a hemiparetic limb in children who have hemiplegic cerebral palsy. The purpose is to provide an effect size estimate that will inform the design of a future study that will compare tele-delivered CIMT with usual and customary care.

Conditions

Hemiplegic Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

• Melbourne Assessment of Unilateral Upper Limb Function

  Measures function of the impaired upper limb

  At baseline pre-treatment and at the end of the 4-week intervention

Secondary Outcomes (3)

• Assisting Hand Assessment

  At baseline pre-treatment and at the end of the 4-week intervention

• Pediatric Motor Activity Log

  At baseline pre-treatment and at the end of the 4-week intervention

• Fidelity to treatment protocol

  During 4 weeks of intervention

Study Arms (1)

Intervention arm

EXPERIMENTAL

This is a single arm in an open label pre- post-treatment design to estimate effect size of the intervention

Other: Constraint induced movement therapy delivered by televideo

Interventions

Constraint induced movement therapy delivered by televideo OTHER

In-home Constraint induced movement therapy delivered by a therapist participating by televideo

Intervention arm

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children who have hemiplegic cerebral palsy, ages 4-10;
• hemiparesis ranging from Manual Ability Classification System (MACS) I to MACS IV;
• live within a 1.5 hour distance from therapists' worksites at the Ohio State University Wexner Medical Center in Columbus, Ohio, or the Fralin Biomedical Research Institute in Roanoke, Virginia;
• are willing to travel to these sites for two in-person assessments.

You may not qualify if:

• Previous high dose CIMT (defined as CIMT given 2 hrs per day for 10 days) in the 6 months preceding baseline assessment;
• Treatment with botulinum toxin for spasticity in the 3 months preceding baseline assessment;
• Surgery for spasticity in the 6 months preceding baseline assessment;
• Medically unstable and unable to participate in the treatment intervention;
• Child is behaviorally or cognitively impaired so unable to participate in the treatment intervention;
• Family unable to participate in tele-delivery of CIMT 5 days a week for 4 weeks;
• the caregiver available at child's treatment site during treatment times is unable to communicate with the treating therapist.

Sponsors & Collaborators

• Warren Lo: lead
• Ohio State University: collaborator
• Virginia Polytechnic Institute and State University: collaborator

Study Sites (2)

The Ohio State University School of Health and Rehabilitation Sciences

Columbus, Ohio, 43210, United States

Location

Virginia Tech-Fralin Biomedical Research Institute

Roanoke, Virginia, 24016, United States

Location

Related Publications (1)

• Ramey SL, DeLuca SC, Stevenson RD, Conaway M, Darragh AR, Lo W; CHAMP. Constraint-Induced Movement Therapy for Cerebral Palsy: A Randomized Trial. Pediatrics. 2021 Nov;148(5):e2020033878. doi: 10.1542/peds.2020-033878. Epub 2021 Oct 14.

  PMID: 34649982 BACKGROUND

Study Officials

• Warren Lo, MD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor, Pediatrics and Neurology

Model Details: Participants with hemiplegic cerebral palsy will be treated with constraint induced movement therapy with the therapist participating by televideo

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 5, 2024
• Study Start: June 27, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)