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Search / Trial NCT06486987

CHAMP T 2 Pilot of CIMT by Tele-Video

Launched by WARREN LO · Jun 27, 2024

Trial Information

Current as of July 24, 2025

Recruiting

Keywords

ClinConnect Summary

The CHAMP-T2 study is looking at a type of therapy called constraint-induced movement therapy (CIMT) to see if it can help children with hemiplegic cerebral palsy when delivered via video calls from home. This therapy aims to improve movement in one arm that may be weaker or less used due to the condition. The researchers want to find out how effective this method is compared to regular care, which will help design a larger study in the future.

To participate, children aged 5 to 10 with hemiplegic cerebral palsy are eligible if they have some movement ability in their affected arm (rated as MACS II to MACS IV) and live within about an hour and a half from the research centers in Ohio or Virginia. Participants will need to commit to doing the therapy five days a week for four weeks with a caregiver who can communicate with the therapist during sessions. It's important to know that children who have received certain treatments recently or have behavioral or cognitive challenges may not be able to join. This study is currently recruiting participants, so families interested in helping their child improve their arm function may want to learn more.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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.
  • Exclusion Criteria:
  • 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.

About Warren Lo

Warren Lo is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes through innovative trial designs and methodologies. With a focus on enhancing therapeutic options across various therapeutic areas, Warren Lo collaborates with leading researchers and healthcare institutions to ensure rigorous study protocols and compliance with regulatory standards. The sponsor prioritizes patient safety and data integrity, striving to contribute valuable insights to the scientific community while fostering transparency and collaboration throughout the clinical development process.

Locations

Columbus, Ohio, United States

Roanoke, Virginia, United States

Patients applied

KC

1 patients applied

Trial Officials

Warren Lo, MD

Principal Investigator

Nationwide Children's Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported