RECRUITING

Motor Training for Infants With Cerebral Palsy

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Conditions

Cerebral Palsymotor skillsoccupational therapyphysical therapy

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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 intervention in this study, Let's Move, is a motor intervention for infants at risk for cerebral palsy. We will test the feasibility and acceptability of the intervention as well as preliminary effectiveness.

Official Title

Motor Training Intervention for Infants at High-Risk for Cerebral Palsy: Feasibility and Acceptability

Quick Facts

Study Start:2022-01-07
Study Completion:2026-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04886895

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:3 Months to 8 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Age at enrollment: between 3-8 months corrected age
  2. * Caregivers fluent in English
  3. * Preterm infants with objectively defined severe diffuse white matter abnormality on MRI at term OR
  4. * High-risk infants (e.g., preterm, neonatal hypoxic-ischemic encephalopathy, perinatal stroke) with moderate-severe injury on structural MRI or cranial ultrasound (e.g., basal ganglia/thalamic signal intensity, cystic periventricular leukomalacia, encephalomalacia, large stroke, and/or severe intraventricular/periventricular hemorrhage) at around term-equivalent age or before Neonatal Intensive Care Unit discharge AND either:
  5. * "Absent" fidgety movements based on the Prechtl General Movement Assessment (GMA) between 3-4 months corrected age OR
  6. * A score of 56 or below on the Hammersmith Infant Neuromotor Examination (HINE) between 3-6 months corrected age (31)
  1. * Medical conditions that restrict active participation such as oxygen dependence
  2. * Infants with significant visual deficits defined by the inability to track an object horizontally
  3. * Living in a remote location prohibiting drives to the hospital every other week.

Contacts and Locations

Study Contact

Karen Harpster, PhD, OTR/L
CONTACT
513-803-3604
karen.harpster@cchmc.org
Nehal A Parikh, DO, MS
CONTACT
513-517-1044
nehal.parikh@cchmc.org

Principal Investigator

Karen Harpster, PhD, OTR/L
PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati

Study Locations (Sites)

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States

Collaborators and Investigators

Sponsor: Children's Hospital Medical Center, Cincinnati

  • Karen Harpster, PhD, OTR/L, PRINCIPAL_INVESTIGATOR, Children's Hospital Medical Center, Cincinnati

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 Date2022-01-07
Study Completion Date2026-01-01

Study Record Updates

Study Start Date2022-01-07
Study Completion Date2026-01-01

Terms related to this study

Keywords Provided by Researchers

  • motor skills
  • occupational therapy
  • physical therapy

Additional Relevant MeSH Terms

  • Cerebral Palsy