ACTIVE_NOT_RECRUITING

CHAMP T 2 Pilot of CIMT by Tele-Video

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Conditions

Hemiplegic Cerebral Palsy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Efficacy of Constraint Induced Movement Therapy Delivered by Tele-Video for Children With Hemiplegic Cerebral Palsy

Quick Facts

Study Start:2024-06-27
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06486987

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:4 Years to 10 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Children who have hemiplegic cerebral palsy, ages 4-10;
  2. * hemiparesis ranging from Manual Ability Classification System (MACS) I to MACS IV;
  3. * 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;
  4. * are willing to travel to these sites for two in-person assessments.
  1. * Previous high dose CIMT (defined as CIMT given 2 hrs per day for 10 days) in the 6 months preceding baseline assessment;
  2. * Treatment with botulinum toxin for spasticity in the 3 months preceding baseline assessment;
  3. * Surgery for spasticity in the 6 months preceding baseline assessment;
  4. * Medically unstable and unable to participate in the treatment intervention;
  5. * Child is behaviorally or cognitively impaired so unable to participate in the treatment intervention;
  6. * Family unable to participate in tele-delivery of CIMT 5 days a week for 4 weeks;
  7. * the caregiver available at child's treatment site during treatment times is unable to communicate with the treating therapist.

Contacts and Locations

Principal Investigator

Warren Lo, MD
PRINCIPAL_INVESTIGATOR
Nationwide Children's Hospital

Study Locations (Sites)

The Ohio State University School of Health and Rehabilitation Sciences
Columbus, Ohio, 43210
United States
Virginia Tech-Fralin Biomedical Research Institute
Roanoke, Virginia, 24016
United States

Collaborators and Investigators

Sponsor: Warren Lo

  • Warren Lo, MD, PRINCIPAL_INVESTIGATOR, Nationwide Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-27
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2024-06-27
Study Completion Date2027-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Hemiplegic Cerebral Palsy