Motor Training for Infants With Cerebral Palsy

NCT04886895 | Recruiting

• 1 other identifier: 2021-0305
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

motor skills; occupational therapy; physical therapy

Outcome Measures

Primary Outcomes (1)

• Change on Peabody Developmental Scales - Second Edition before and after intervention and follow-up

  Motor test

  Baseline,16 weeks, 28 weeks

Secondary Outcomes (4)

• Change on Pediatric Evaluation of Disability Inventory-Computer Adaptive Test before and after intervention and follow-up

  Baseline,16 weeks, 28 weeks

• Change on Canadian Occupational Performance Measure before and after intervention and follow-up

  Baseline,16 weeks, 28 weeks

• Change on Hammersmith Infant Neurological Exam before and after intervention and follow-up

  Baseline,16 weeks, 28 weeks

• Preverbal visual assessment (PreViAs

  Enrollment, 4 months later, 8 months later

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

Intervention group: Let's Move

EXPERIMENTAL

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

Interventions

Let's Move Motor Intervention OTHER

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

Control group; Intervention group: Let's Move

Eligibility Criteria

• Age: 3 Months - 8 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Karen Harpster, PhD, OTR/L

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Single cohort

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 14, 2021
• Study Start: January 7, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: September 25, 2025

Record last verified: 2025-09

Locations

US (1)