What is this study testing for infants with motor delay?

This study is testing an early physical therapy intervention to improve motor function and reduce motor delays in infants admitted to the NICU. The trial also looks at how supporting caregivers might improve their well-being. The research is sponsored by Shirley Ryan AbilityLab and aims to help infants at high risk for motor delays.

Who may be eligible for this motor delay clinical trial?

Infants between 33 and 48 weeks postmenstrual age who were admitted to the NICU and qualify for high-risk early intervention due to low birth weight or brain and lung conditions may be eligible. Caregivers must speak English, and the infant must be medically stable. Please review eligibility criteria for more details.

Is there any cost to participate in this motor delay clinical trial?

Study-related care, including the therapy and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel costs.

Actively Recruiting

Phase Not Applicable

Age: 33Weeks - 48Weeks

All Genders

ID05568264

Early Detection and Therapeutic Improvement of Motor Delay in High Risk Infants A Randomized, Controlled Trial

Led by Shirley Ryan AbilityLab · Updated on 2025-05-21

222

Participants Needed

Research Sites

30 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are conducting a randomized controlled trial to study motor delays in infants admitted to the Neonatal Intensive Care Unit NICU. The study aims to evaluate an early physical therapy intervention intended to improve motor function and reduce motor delays by 12 months corrected age. It also seeks to assess early effects of the intervention before 12 months and examine whether caregiver-focused support improves caregiver well-being. Infants will be randomly assigned to either an intervention group receiving up to two therapist visits per week in addition to standard care or a standard care group. The intervention begins in the NICU and continues until 12 months corrected age. Caregivers receive resources and guidance to engage in activities with their infants throughout the day. All participants may also access other therapies or medical services as recommended. Participants will undergo assessments at scheduled intervals up to 12 months corrected age, with optional follow-ups at 18 and 24 months. These include motor function tests, movement quality monitoring using wearable sensors, and caregiver well-being surveys. Medical records will be reviewed to track standard care services. Caregivers may be invited to focus groups or interviews about the study experience. The main measurement is the Bayley-4 motor score at 12 months corrected age.

CONDITIONS

Brief 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

You may qualify if you...

Infant admitted to NICU and qualifies for high-risk early intervention due to birth weight less than 1500 grams or central nervous system disorders including brain injury or developmental abnormalities
Infant with bronchopulmonary dysplasia requiring respiratory support at 36 weeks postmenstrual age if born before 32 weeks gestation
Medically stable infant able to start intervention between 34 and 48 weeks postmenstrual age
Caregivers able to speak English

You will not qualify if you...

Open wounds or skin conditions preventing sensor placement
Immune deficiencies needing protective isolation
Limb reduction defects
Primarily followed in another clinic for certain conditions (e.g., meningomyelocele, trisomy 21)
Bleeding disorders or ongoing anticoagulation
Receiving palliative or hospice care for life-limiting conditions
Known visual impairment at enrollment
Child under Department of Children and Family Services custody
Non-English speaking caregivers
Any other condition preventing study participation as determined by the principal investigator
Previously enrolled in competing randomized trials with developmental outcome variables

Research Team

Elizabeth Hoffman, DPT

Sara Prokup, DPT

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