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Search / Trial NCT05781438

Feasibility of an In-home Standing and Walking Intervention for Infants With and at High Risk of Cerebral Palsy

Launched by UNIVERSITY OF SOUTHERN CALIFORNIA · Mar 11, 2023

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

Infant

ClinConnect Summary

This clinical trial is looking at a new program to help infants who have or are at high risk of developing cerebral palsy (CP) learn to stand and walk better. The researchers want to see if an intensive training program done at home can be helpful for these young children. They are currently recruiting infants between 5 months and 2 years old who either have been diagnosed with CP or show signs that they might develop it. To qualify, the child must have certain brain imaging results and specific scores on a neurological examination.

If a child joins this study, parents can expect to work with study personnel who will guide them through the standing and walking exercises at home. The goal is to see if this targeted support can improve the child's mobility. It’s important to note that some children may not be eligible to participate, such as those with certain medical conditions or those who weigh more than 50 pounds. This trial represents an exciting opportunity to explore new ways to support infants with CP and help them reach their mobility milestones.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • * Infants with or at high risk of cerebral palsy (CP) who either:
  • have been diagnosed with CP by a medical professional, or
  • * are at high risk of CP defined as having both:
  • clinical brain imaging indicating CP, such as (i) white matter injury (cystic periventricular leukomalacia or periventricular hemorrhagic infarctions), (ii) hypoxic-ischemic encephalopathy, or (iii) neonatal stroke, and
  • a score less than 63 or more than 5 asymmetries on the Hammersmith Infant Neurological Examination (HINE).
  • Exclusion Criteria:
  • prenatal substance abuse,
  • congenital malformations,
  • drug-resistant epilepsy,
  • visual impairment that hinders the infant from seeing toys,
  • hearing impairment that hinders the infant from responding to sound,
  • living in a location inaccessible by study personnel for in-home data collections,
  • participant over 50 lbs in weight.

About University Of Southern California

The University of Southern California (USC) is a prestigious research institution located in Los Angeles, California, known for its commitment to advancing knowledge and innovation in various fields, including medicine and health sciences. As a clinical trial sponsor, USC leverages its extensive resources, interdisciplinary expertise, and state-of-the-art facilities to conduct cutting-edge research aimed at improving patient outcomes and public health. The university fosters collaboration among its diverse faculty and students, ensuring a dynamic environment for the development and implementation of clinical studies that adhere to the highest ethical and scientific standards. Through its clinical trials, USC aims to contribute to the advancement of medical science and the translation of research findings into practical applications that benefit communities locally and globally.

Locations

Los Angeles, California, United States

Patients applied

0 patients applied

Trial Officials

Barbara Sargent, PhD, PT

Principal Investigator

University of Southern California, Division of Biokinesiology and Physical Therapy

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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