Motor Training for Infants With Cerebral Palsy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy
• Intervention / Treatment: Other: Let's Move Motor Intervention

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 Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karen Harpster, PhD, OTR/L; Phone Number: 513-803-3604; Email: karen.harpster@cchmc.org
• Study Contact Backup: Name: Nehal A Parikh, DO, MS; Phone Number: 513-517-1044; Email: nehal.parikh@cchmc.org

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Recruiting
      • Cincinnati Children's Hospital Medical Center
      • Contact: Nehal A Parikh, DO, MS; Phone Number: 513 517-1044; Email: nehal.parikh@cchmc.org
      • Contact: Karen L Harpster, PhD, OTR/L; Phone Number: 513-803-3604; Email: karen.harpster@cchmc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 8 months (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; Infants randomized to the usual care arm will receive usual care for 4 months. Therapy services provided to infants at this age vary in terms of frequency, location, and provider. Usual care is prescribed by the child's primary care provider (PCP), and in this population, usual care typically consists of one or both of the following: Early intervention therapy services provided by the state or Therapy in an outpatient clinic. Control group participants will be offered the Let's Move interventions after 16 weeks of control group.	Other: Let's Move Motor Intervention; Let's Move intervention will be administered and videotaped with 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, we will attempt to schedule two clinic-based sessions followed by 2 telehealth-based sessions
Experimental: Intervention group: Let's Move; Infants randomized to the Let's Move intervention group will be scheduled for therapy one time per week for 16 sessions (approximately 30-60 minutes per session). The intervention setting will involve both in-person (CCHMC clinic or in-home) and telehealth (in-home, video-based) sessions. The therapist will provide the caregivers with home programs to complete between therapy sessions (5 days per week). The home program will be based on the infant's goals set collaboratively between the caregiver and the evaluating therapist at the baseline assessment using the Canadian Occupational Performance Measure (COPM). At least half of the intervention sessions will be video recorded to assess feasibility and monitor intervention fidelity.	Other: Let's Move Motor Intervention; Let's Move intervention will be administered and videotaped with 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, we will attempt to schedule two clinic-based sessions followed by 2 telehealth-based sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change on Peabody Developmental Scales - Second Edition before and after intervention and follow-up	Motor test	Baseline,16 weeks, 28 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Change on Hammersmith Infant Neurological Exam before and after intervention and follow-up	Neurological exam	Baseline,16 weeks, 28 weeks
Preverbal visual assessment (PreViAs	Screening tool for the development of visual maturation	Enrollment, 4 months later, 8 months later

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Investigators: Principal Investigator: Karen Harpster, PhD, OTR/L, Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: April 29, 2021
• First Submitted That Met QC Criteria: May 13, 2021
• First Posted (Actual): May 14, 2021

Study Record Updates

• Last Update Posted (Estimated): September 25, 2025
• Last Update Submitted That Met QC Criteria: September 22, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: physical therapy; occupational therapy; motor skills
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: 2021-0305

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No