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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3 months
Maximum Age: 8 months
Healthy Volunteers: f
View:

• 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)

Locations
United States
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Contact Information
Primary
Karen Harpster, PhD, OTR/L
karen.harpster@cchmc.org
513-803-3604
Backup
Nehal A Parikh, DO, MS
nehal.parikh@cchmc.org
513-517-1044
Time Frame
Start Date: 2022-01-07
Estimated Completion Date: 2028-01-01
Participants
Target number of participants: 35
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Children's Hospital Medical Center, Cincinnati

This content was sourced from clinicaltrials.gov