Motor Training for Infants With Cerebral Palsy

NCT ID: NCT04886895

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-07
• Study Completion Date: 2028-01-01

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.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Let's Move Motor Intervention

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Let's Move Motor Intervention

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 8 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Karen Harpster

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karen Harpster, PhD, OTR/L

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Karen Harpster, PhD, OTR/L

Role: CONTACT

karen.harpster@cchmc.org

513-803-3604

Nehal A Parikh, DO, MS

Role: CONTACT

nehal.parikh@cchmc.org

513-517-1044

Facility Contacts

Karen L Harpster, PhD, OTR/L

Role: primary

karen.harpster@cchmc.org

513-803-3604

Nehal A Parikh, DO, MS

Role: backup

nehal.parikh@cchmc.org

513 517-1044

Other Identifiers

2021-0305

Identifier Type: -

Identifier Source: org_study_id