RecruitingNot Applicable

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

United States222 participantsStarted 2022-10-01

Plain-language summary

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).

Who can participate

Age range

33 Weeks – 48 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: NICU admission and qualifies for Early Childhood Clinic (NICU high-risk follow up clinic) or Early Intervention due to: * BW \<1500 grams OR * 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 OR * Bronchopulmonary dysplasia (BPD) defined as need for respiratory support at 36 weeks postmenstrual age in an infant born at \<32 weeks of gestation. AND * Medically stable AND able to start intervention between 34-48 weeks PMA. Exclusion Criteria: (related to inability to complete intervention, sensor placement, or clinic assessments) * 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) * kn…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Bayley-4 motor score at 12-months corrected age

Timeframe: Bayley-4 motor score assessed at 12-months CA will be the primary outcome

Trial details

NCT IDNCT05568264

SponsorShirley Ryan AbilityLab

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-31

Contact for this trial

Elizabeth Hoffman, DPT

312-238-7711 ehoffman@sralab.org

View on ClinicalTrials.gov More Motor Delay trials