Motor Training for Infants With Cerebral Palsy

Cincinnati Children's Hospital Medical Center

Status: Enrolling

Conditions: Cerebral Palsy

Treatments: Other: Let's Move Motor Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04886895

2021-0305

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 estimated patients

Sex: All

Ages: 3 to 8 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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35 participants in 2 patient groups

Control group

Active Comparator group

Description:

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.

Treatment:

Other: Let's Move Motor Intervention

Intervention group: Let's Move

Experimental group

Description:

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.

Treatment:

Other: Let's Move Motor Intervention