Effects of a Physical Therapy Intervention on Motor Delay in Infants Admitted to a Neonatal Intensive Care Unit
Early Detection and Therapeutic Improvement of Motor Delay in High Risk Infants: A Randomized, Controlled Trial
1 other identifier
interventional
222
1 country
3
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2022
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2022
CompletedStudy Start
First participant enrolled
October 1, 2022
CompletedFirst Posted
Study publicly available on registry
October 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
May 21, 2025
May 1, 2025
3.7 years
September 27, 2022
May 19, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Bayley-4 motor score at 12-months corrected age
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.
Bayley-4 motor score assessed at 12-months CA will be the primary outcome
Secondary Outcomes (3)
Movement quality assessed by wearable sensors
At each assessment timepoint, including study enrollment, monthly up to 3 months corrected age (CA), 3-month CA, 6-months CA, 9-months CA, 12-months CA, 18-months CA (optional), and 24-months CA (optional).
Pediatric Quality of Life Inventory (PedsQL)
PedsQL will be completed once during NICU stay (up to 45 days post enrolment), at one-and two-month intervals after enrollment; at 3-month corrected age (CA), 6-months CA, 9-months CA, 12-months CA, 18-months CA (optional), and 24-months CA (optional).
Bayley-4 Cognitive score Bayley-4 Cognitive score Bayley-4 Cognitive score
The Bayley-4 cognitive score will be assessed at 6-months corrected age (CA), 12-months CA, 18-months CA (optional), and 24-months CA (optional).
Other Outcomes (8)
Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT) Mobility Domain
The PEDI-CAT will be administered at 12-months corrected age (CA), at 18-months CA (optional), and at 24-months CA (optional).
Warner Initial Developmental Evaluation of Adaptive and Functional Skills (WIDEA-FS)
The WIDEA-FS will be administered at 12-months corrected age (CA), and at 18-months CA (optional) and 24-months CA (optional).
Hammersmith Infant Neurological Exam (HINE)
The HINE will be performed at 3-months corrected age (CA), 6-months CA, 9-months CA, and 12-months CA.
- +5 more other outcomes
Study Arms (2)
Physical Therapy Intervention
EXPERIMENTALInfants enrolled in this arm will receive the intervention in addition to standard of care
Standard of Care
NO INTERVENTIONInfants enrolled in this arm will receive standard of care
Interventions
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
You may qualify if:
- NICU admission and qualifies for Early Childhood Clinic (NICU high-risk follow up clinic) or Early Intervention due to:
- 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.
- AND
- Medically stable AND able to start intervention between 34-48 weeks PMA.
You may not qualify if:
- (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 the study team to confirm eligibility.
Sponsors & Collaborators
- Shirley Ryan AbilityLablead
- Ann & Robert H Lurie Children's Hospital of Chicagocollaborator
- Northwestern Universitycollaborator
- Northwestern Medicinecollaborator
- University of Illinois at Chicagocollaborator
Study Sites (3)
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Northwestern Medicine Prentice Children's Hospital
Chicago, Illinois, 60611, United States
Children's Hospital at the University of Illinois
Chicago, Illinois, 60612, United States
Related Publications (1)
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.
PMID: 37725613DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arun Jayaraman, PT, PhD
Shirley Ryan AbilityLab
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Clinicians involved in clinical assessments are blinded to study group
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Investigator
Study Record Dates
First Submitted
September 27, 2022
First Posted
October 5, 2022
Study Start
October 1, 2022
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
May 21, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share