Actively Recruiting
Led by Shirley Ryan AbilityLab · Updated on 2025-05-21
222
Participants Needed
3
Research Sites
30 weeks
Total Duration
S
Shirley Ryan AbilityLab
Lead Sponsor
A
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborating Sponsor
Researchers are conducting a randomized controlled trial to study motor delays in infants admitted to the Neonatal Intensive Care Unit (NICU). The study aims to evaluate an early physical therapy intervention intended to improve motor function and reduce motor delays by 12 months corrected age. It also seeks to assess early effects of the intervention before 12 months and examine whether caregiver-focused support improves caregiver well-being. Infants will be randomly assigned to either an intervention group receiving up to two therapist visits per week in addition to standard care or a standard care group. The intervention begins in the NICU and continues until 12 months corrected age. Caregivers receive resources and guidance to engage in activities with their infants throughout the day. All participants may also access other therapies or medical services as recommended. Participants will undergo assessments at scheduled intervals up to 12 months corrected age, with optional follow-ups at 18 and 24 months. These include motor function tests, movement quality monitoring using wearable sensors, and caregiver well-being surveys. Medical records will be reviewed to track standard care services. Caregivers may be invited to focus groups or interviews about the study experience. The main measurement is the Bayley-4 motor score at 12 months corrected age.
CONDITIONS
Effects of a Physical Therapy Intervention on Motor Delay in Infants Admitted to a Neonatal Intensive Care Unit
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From as early as possible in the NICU until 12 months corrected age
Participants in the intervention group receive up to two therapist visits per week in addition to standard of care physical therapy. Caregivers work with their infant on activities provided by the therapist throughout the day. Participants in the standard of care group continue with routine care. All participants complete assessments and surveys at defined time points to monitor development and caregiver engagement.
Up to 2 therapist visits per week plus scheduled assessments at enrollment, monthly up to 3 months corrected age, and at 3, 6, 9, and 12 months corrected age
Duration - Optional visits at 18 and 24 months corrected age
Optional assessments and surveys continue at 18 and 24 months corrected age to further evaluate motor and cognitive development and caregiver well-being.
Optional visits at 18 and 24 months corrected age
Total: 3 locations
1
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
2
Northwestern Medicine Prentice Children's Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
3
Children's Hospital at the University of Illinois
Chicago, Illinois, United States, 60612
Actively Recruiting
E
Elizabeth Hoffman, DPT
S
Sara Prokup, DPT
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Weiyang Deng, Sofia Anastasopoulos, Raye-Ann deRegnier...
https://pubmed.ncbi.nlm.nih.gov/37725613