NCT05568264 Effects of a Physical Therapy Intervention on Motor Delay in Infants Admitted to a Neonatal Intensive Care Unit
| NCT ID | NCT05568264 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shirley Ryan AbilityLab |
| Condition | Motor Delay |
| Study Type | INTERVENTIONAL |
| Enrollment | 222 participants |
| Start Date | 2022-10-01 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 222 participants in total. It began in 2022-10-01 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
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) * 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 Each child's enrollment in the study will be approved by the child's neonatologist.
Contact & Investigator
Arun Jayaraman, PT, PhD
PRINCIPAL INVESTIGATOR
Shirley Ryan AbilityLab
Frequently Asked Questions
Who can join the NCT05568264 clinical trial?
This trial is open to participants of all sexes, aged 33 Weeks or older, up to 48 Weeks, studying Motor Delay. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05568264 currently recruiting?
Yes, NCT05568264 is actively recruiting participants. Contact the research team at ehoffman@sralab.org for enrollment information.
Where is the NCT05568264 trial being conducted?
This trial is being conducted at Chicago, United States, Chicago, United States, Chicago, United States.
Who is sponsoring the NCT05568264 clinical trial?
NCT05568264 is sponsored by Shirley Ryan AbilityLab. The principal investigator is Arun Jayaraman, PT, PhD at Shirley Ryan AbilityLab. The trial plans to enroll 222 participants.