Motor Training for Infants With Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04886895
• Other study ID #: 2021-0305
• Status: Recruiting
• Phase: N/A
• Start date: January 7, 2022
• Est. completion date: January 1, 2026

Study information

• Verified date: January 2024
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: Karen Harpster, PhD, OTR/L
• Phone: 513-803-3604
• Email: karen.harpster[@]cchmc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The aims of this study are to test the feasibility, acceptability, and operationalize a novel motor intervention, called "Let's Move" delivered using a combined clinic and home (video telehealth) therapy model.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 8 Months

Eligibility

Inclusion Criteria:

• Age at enrollment: between 3-8 months corrected age

• Caregivers fluent in English

• Preterm infants with objectively defined severe diffuse white matter abnormality on MRI at term OR

• 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:

• "Absent" fidgety movements based on the Prechtl General Movement Assessment (GMA) between 3-4 months corrected age OR

• A score of 56 or below on the Hammersmith Infant Neuromotor Examination (HINE) between 3-6 months corrected age (31)

Exclusion Criteria:

• Medical conditions that restrict active participation such as oxygen dependence

• Infants with significant visual deficits defined by the inability to track an object horizontally

• Living in a remote location prohibiting drives to the hospital every other week.

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Other:
• Let's Move
Motor intervention

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change on Peabody Developmental Scales - Second Edition before and after intervention and follow-up	Motor test	Baseline,16 weeks, 28 weeks
Secondary	Change on Pediatric Evaluation of Disability Inventory-Computer Adaptive Test before and after intervention and follow-up	Parent reported test for functional performance	Baseline,16 weeks, 28 weeks
Secondary	Change on Canadian Occupational Performance Measure before and after intervention and follow-up	Caregivers perception of child's performance on functional goals	Baseline,16 weeks, 28 weeks
Secondary	Change on Hammersmith Infant Neurological Exam before and after intervention and follow-up	Neurological exam	Baseline,16 weeks, 28 weeks