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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age33-48
SponsorShirley Ryan AbilityLab

About this trial

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

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Physical Therapy intervention

Treatment groups

222 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Shirley Ryan AbilityLab

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Collaborator

Northwestern University

Collaborator

Northwestern Medicine

Collaborator

University of Illinois at Chicago

Collaborator