Let's Move, an early movement program for infants at risk of cerebral palsy
Tests a movement training program in babies at risk of cerebral palsy.
Key facts
- Who runs it
- Children's Hospital Medical Center, Cincinnati
- Where
- Cincinnati, United StatesSee the site
- Trial code
- Registry title
- Motor Training for Infants With Cerebral Palsy
- Status
- Recruiting
- People taking part
- 35 people, planned
- Started
- 7 Jan 2022
- Expected to end
- 1 Jan 2028
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Let's Move Motor Intervention
- Record updated
- 12 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for babies at high risk of cerebral palsy, shown by brain scans and movement tests. It tests a motor training program called Let's Move.
- Age
- 3 to 8 months corrected age (age counted from the due date)
- Sex
- All
- Disease stage
- High risk of cerebral palsy. Babies born early need severe white matter changes on an MRI at term. Other high-risk babies need moderate to severe brain injury on MRI or head ultrasound. Examples are preterm birth, lack of oxygen around birth, or a stroke around birth.
- Biomarker or test result
- Babies with brain injury on MRI or ultrasound also need one of these test results: 'absent' fidgety movements on the Prechtl General Movement Assessment (GMA) at 3-4 months corrected age, or a score of 56 or below on the Hammersmith Infant Neuromotor Examination (HINE) at 3-6 months corrected age. Caregivers must speak English fluently.
Main reasons for not taking part
- Medical conditions that limit active taking part, such as needing oxygen
- Serious sight problems: cannot follow an object moving side to side
- Living too far away to drive to the hospital every other week
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- 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)
Who cannot take part
- 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
Where in United States
- Cincinnati Children's Hospital Medical CenterCincinnati, United StatesContact: Karen L Harpster, PhD, OTR/LTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Control groupExisting treatment, for comparison
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: Let's Move Motor Intervention
- Intervention group: Let's MoveTreatment being tested
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: Let's Move Motor Intervention
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Motor Training Intervention for Infants at High-Risk for Cerebral Palsy: Feasibility and Acceptability
- Plain-language title
- Let's Move, an early movement program for infants at risk of cerebral palsyGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 12 November 2026