Actively Recruiting
Effects of a Physical Therapy Intervention on Motor Delay in Infants Admitted to a Neonatal Intensive Care Unit
Led by Shirley Ryan AbilityLab · Updated on 2025-05-21
222
Participants Needed
3
Research Sites
221 weeks
Total Duration
On this page
Sponsors
S
Shirley Ryan AbilityLab
Lead Sponsor
A
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborating Sponsor
AI-Summary
What this Trial Is About
Study Aims Pilot study: Due to the large recruitment goal and length of the project, the study team/PIs will evaluate the first cohort of 6-10 participants to refine study procedures and study-related materials. If no major modifications are made to the protocol as a result of this evaluation, data from these participants will be included for analysis. Aim 1: Evaluate the efficacy of an early, evidence-based, clinical experience-based therapeutic intervention (from the NICU to 12-months corrected age) on improving motor function and reducing severity of motor delays in infants at 12-months corrected age. The investigators hypothesize that the intervention group will demonstrate an average 8-point difference (0.5 standard deviation) compared to the standard of care group. \[an 8-point difference is considered a clinically meaningful difference\] Aim 2: Evaluate the early effects (i.e., before 12 months) of a therapeutic intervention, provided from NICU to 12-months corrected age, on motor function and severity of motor delay. The Investigators hypothesize that a statistically significant higher percentage of infants in the intervention group will demonstrate improved motor function and reduced severity of motor delays, compared to the standard of care group-assessed using sensors, the NSMDA and TIMP-as early as 3-months corrected age. Aim 3: Evaluate whether an early intervention that focuses on caregiver engagement improves caregiver well-being. The invetigators hypothesize that an intervention that focuses on supporting and addressing the individual needs of the caregiver will improve caregiver well-being. The investigators will evaluate these effects using the PedsQL (Family Impact Module).
CONDITIONS
Official Title
Effects of a Physical Therapy Intervention on Motor Delay in Infants Admitted to a Neonatal Intensive Care Unit
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infant admitted to the NICU and qualifies for early childhood clinic or early intervention due to:
- Birth weight less than 1500 grams
- Central nervous system disorders such as brain injury (including hemorrhage, stroke, hypoxic-ischemic encephalopathy, meningitis)
- Brain developmental abnormalities (hydrocephalus, microcephaly, cortical dysgenesis)
- Cramped synchronous movements at term postmenstrual age
- Bronchopulmonary dysplasia needing respiratory support at 36 weeks postmenstrual age in infants born before 32 weeks gestation
- Medically stable and able to start intervention between 34 and 48 weeks postmenstrual age
You will not qualify if you...
- Open wounds or skin conditions preventing sensor placement
- Immune deficiencies requiring protective isolation
- Limb reduction defects
- Primarily followed in another clinic (including meningomyelocele or trisomy 21)
- Bleeding disorders or ongoing need for blood thinning treatment
- Receiving palliative or hospice care for life-limiting conditions (such as trisomy 13 or 18)
- Known visual impairment at enrollment
- In custody of child protective services (DCFS)
- No English-speaking caregivers
- Any condition preventing participation as determined by the principal investigator
- Previously enrolled in a competing randomized trial with developmental outcomes
- Enrollment approved by the child's neonatologist
AI-Screening
AI-Powered Screening
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Trial Site Locations
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
Research Team
E
Elizabeth Hoffman, DPT
CONTACT
S
Sara Prokup, DPT
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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