Effects of a Physical Therapy Intervention on Motor Delay in Infants Admitted to a Neonatal Intensive Care Unit
NCT ID: NCT05568264
Last Updated: 2025-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
222 participants
INTERVENTIONAL
2022-10-01
2026-12-31
Brief Summary
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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).
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Detailed Description
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The intervention will start as early as possible (in the NICU) and continue until 12-months corrected age. Infants in the intervention group will receive up to two therapist visits per week in addition to standard of care physical therapy. Caregivers will be asked to work with their infant on activities provided by the therapist. The therapist will provide resources to support the caregiver in working on these activities with their child, and caregivers will be asked to complete the activities for as much time as possible, throughout the day. Therapists will work with caregivers to identify ways to incorporate activities into their day.
All infants in the study will be eligible to receive any services recommended or prescribed by their medical team and all families will be able to seek out and receive therapy or medical services outside of the study, without limitation.
All enrolled participants, regardless of group allocation, will complete sets of assessments at defined time points up to 12-months corrected age, with optional assessments at 18 and 24-months corrected age. The investigators will also ask all caregivers to complete surveys at defined time-points throughout the study to collect participant updates, information on infant development, and to monitor services received, caregiver engagement, and caregiver well-being. Caregivers may be invited to participate in a focus group and/or semi-structured interviews to evaluate study perceptions. Medical record review will be completed to evaluate standard-of-care services and medical history (as available).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Physical Therapy Intervention
Infants enrolled in this arm will receive the intervention in addition to standard of care
Physical Therapy intervention
The intervention is based on five principles: active learning, caregiver engagement, environmental enrichment, strengths-based approach, and dose. The intervention will start in the NICU and continue until 12-months corrected age. Infants in the intervention group will receive up to two therapist visits per week in addition to standard of care physical therapy. Caregivers will be asked to work with their infant on activities provided by the therapist. The therapist will provide resources to support the caregiver in working on these activities with their child, and caregivers will be asked to complete the activities for as much time as possible, throughout the day. Therapists will work with caregivers to identify ways to incorporate activities into their day. Caregiver engagement and caregiver ability to complete sessions and activity recommendations will be monitored.
Standard of Care
Infants enrolled in this arm will receive standard of care
No interventions assigned to this group
Interventions
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Physical Therapy intervention
The intervention is based on five principles: active learning, caregiver engagement, environmental enrichment, strengths-based approach, and dose. The intervention will start in the NICU and continue until 12-months corrected age. Infants in the intervention group will receive up to two therapist visits per week in addition to standard of care physical therapy. Caregivers will be asked to work with their infant on activities provided by the therapist. The therapist will provide resources to support the caregiver in working on these activities with their child, and caregivers will be asked to complete the activities for as much time as possible, throughout the day. Therapists will work with caregivers to identify ways to incorporate activities into their day. Caregiver engagement and caregiver ability to complete sessions and activity recommendations will be monitored.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
33 Weeks
48 Weeks
ALL
No
Sponsors
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Ann & Robert H Lurie Children's Hospital of Chicago
OTHER
Northwestern University
OTHER
Northwestern Medicine
OTHER
University of Illinois at Chicago
OTHER
Shirley Ryan AbilityLab
OTHER
Responsible Party
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Arun Jayaraman, PT, PhD
Investigator
Principal Investigators
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Arun Jayaraman, PT, PhD
Role: PRINCIPAL_INVESTIGATOR
Shirley Ryan AbilityLab
Locations
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Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Northwestern Medicine Prentice Children's Hospital
Chicago, Illinois, United States
Children's Hospital at the University of Illinois
Chicago, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Deng W, Anastasopoulos S, deRegnier RA, Pouppirt N, Barlow AK, Patrick C, O'Brien MK, Babula S, Sukal-Moulton T, Peyton C, Morgan C, Rogers JA, Lieber RL, Jayaraman A. Protocol for a randomized controlled trial to evaluate a year-long (NICU-to-home) evidence-based, high dose physical therapy intervention in infants at risk of neuromotor delay. PLoS One. 2023 Sep 19;18(9):e0291408. doi: 10.1371/journal.pone.0291408. eCollection 2023.
Other Identifiers
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IRB 2022 5243
Identifier Type: -
Identifier Source: org_study_id
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