Back to search results

Physical Therapy for Motor Delay in NICU Infants

This study is testing a special physical therapy program for infants who were in the Neonatal Intensive Care Unit (NICU) and are at risk for motor delays. The program, called "Physical Therapy intervention," focuses on active learning, involving parents, enriching the environment, building on strengths, and providing enough therapy. It starts in the NICU and continues until your baby is 12 months old (corrected age). Researchers want to see if this intervention can improve motor skills and reduce the severity of motor delays. You might be able to join if your baby was in the NICU, was born prematurely (under 1500 grams), or had certain brain injuries like intraventricular hemorrhage (bleeding in the brain) or hypoxic-ischemic encephalopathy (HIE, brain injury from lack of oxygen). The study aims to enroll 222 infants.

Study design
This is a randomized controlled trial, meaning participants will be randomly assigned to either receive the special physical therapy or standard care. The study plans to enroll 222 infants.
What's involved
If your baby is in the intervention group, they will receive up to two therapist visits per week in addition to standard care. You will be asked to work with your baby on activities provided by the therapist.
Compensation
Not stated in the trial record.
Follow-up
Your baby's motor skills will be assessed at 12 months corrected age, which is the primary endpoint for the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05568264

Effects of a Physical Therapy Intervention on Motor Delay in Infants Admitted to a Neonatal Intensive Care Unit

Active, Not Recruiting
NAAges 33–48InterventionalTreatment
Shirley Ryan AbilityLab
~222 participants
Updated 2026-07-31 on ClinicalTrials.gov
What's tested:Physical Therapy intervention

At a glance

Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Bayley-4 motor score at 12-months corrected age
Measured over Bayley-4 motor score assessed at 12-months CA will be the primary outcome

Conditions

Motor Delay
Premature Birth
Intraventricular Hemorrhage
Hypoxic-Ischemic Encephalopathy
Bronchopulmonary Dysplasia

Explore related trials

Bronchopulmonary DysplasiaClumsiness - motor delayHypoxic Ischemic EncephalopathyIntraventricular Brain HemorrhagePreterm Birth

Where it's being run

3 sites across 1 states
Illinois3

Study leadership

  • Arun Jayaraman, PT, PhD · PRINCIPAL_INVESTIGATOR · Shirley Ryan AbilityLab

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

BW \<1500 grams
Disorders of the central nervous system
Brain injury (including but not limited to extra axial hemorrhage, any grade intraventricular or intraparenchymal hemorrhage, stroke, hypoxic ischemic encephalopathy (HIE), meningitis)
HIE includes mild, moderate, severe exam on modified Sarnat exam, both cooled and non-cooled
includes "at risk for HIE" with 10-minute Apgar \<7 plus pH\<7.15 or base deficit \>/=12.
Brain developmental abnormalities (hydrocephalus, microcephaly, cortical dysgenesis)
Cramped synchronous movements at term PMA
Bronchopulmonary dysplasia (BPD) defined as need for respiratory support at 36 weeks postmenstrual age in an infant born at \<32 weeks of gestation.
Medically stable AND able to start intervention between 34-48 weeks PMA.

Exclusion

open wounds, skin condition precluding sensor placement
immune deficiencies requiring protective isolation
limb reduction defects
followed primarily in another clinic (including but not limited to meningomyelocele and related conditions/trisomy 21)
bleeding disorders or ongoing need for anticoagulation
palliative or hospice care (for life limiting conditions including, but not limited to trisomy 18, 13)
known visual impairment at the time of enrollment
DCFS custody
no English-speaking caregivers
any other condition that would preclude participation in the study, as determined by the PI
previously enrolled in competing randomized trial with developmental outcome variables

What this trial measures

  • Bayley-4 motor score at 12-months corrected ageBayley-4 motor score assessed at 12-months CA will be the primary outcome

    The Bayley-4 is an individually administered instrument that assesses the developmental functioning of infants and young children, aged between 16 days and 42 months, by observing the child's interaction with stimuli designed to engage them. It assesses five domains: Motor, Cognitive, Language, Social-emotional, and Adaptive behavior. The primary outcome will be the Bayley-4 motor score at 12-months corrected age. The standard scores range from 45-155 for the motor domain. Higher scores indicate better outcomes.