Motor Training for Infants With Cerebral Palsy

Not Applicable

Recruiting

• Conditions: Cerebral Palsy
• Interventions: Other: Let's Move

• Registration Number: NCT04886895
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-04-29
• Study First Submitted QC: 2021-05-13
• Study First Posted: 2021-05-14
• Study Start: 2022-01-07
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-16
• Last Update Posted: 2024-01-18
• Primary Completion: 2025-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Let's Move Intervention	Let's Move	Let's Move intervention will be administered and videotaped for 20 infant/caregiver dyads. Therapy will occur weekly (30-60 minutes per session) for 16 weeks, alternating between clinic and home (video telehealth) sessions. Each month, there will be two clinic-based sessions followed by 2 telehealth-based sessions

Primary Outcome Measures

Name	Time	Method
Change on Peabody Developmental Scales - Second Edition before and after intervention and follow-up	Baseline,16 weeks, 28 weeks	Motor test

Secondary Outcome Measures

Name	Time	Method
Change on Canadian Occupational Performance Measure before and after intervention and follow-up	Baseline,16 weeks, 28 weeks	Caregivers perception of child's performance on functional goals
Change on Hammersmith Infant Neurological Exam before and after intervention and follow-up	Baseline,16 weeks, 28 weeks	Neurological exam
Change on Pediatric Evaluation of Disability Inventory-Computer Adaptive Test before and after intervention and follow-up	Baseline,16 weeks, 28 weeks	Parent reported test for functional performance

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States