Condition: Motor Delay · Premature Birth · Intraventricular Hemorrhage · Sponsor: Shirley Ryan AbilityLab
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 hypoth…
This description comes directly from the study's public registry record.
Elizabeth Hoffman, DPT · 312-238-7711 · ehoffman@sralab.org
Sara Prokup, DPT · 312-238-1355 · sprokup@sralab.org
Always discuss trial participation with your own doctor first.
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago, Illinois, United States | Recruiting |
| Northwestern Medicine Prentice Children's Hospital | Chicago, Illinois, United States | Recruiting |
| Children's Hospital at the University of Illinois | Chicago, Illinois, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05568264