Actively Recruiting

Phase Not Applicable
Age: 33Weeks - 48Weeks
All Genders
NCT05568264

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

Age: 33Weeks - 48Weeks
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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