In-home intervention for infants at risk of cerebral palsy
Feasibility of an In-home Standing and Walking Intervention for Infants With and at High Risk of Cerebral Palsy
NA · University of Southern California · NCT05781438
This study is testing whether a special in-home program that helps infants at risk of cerebral palsy practice standing and walking can improve their motor skills.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 8 (estimated) |
| Ages | 5 Months to 2 Years |
| Sex | All |
| Sponsor | University of Southern California (other) |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT05781438 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility and initial effects of an intensive in-home standing and walking intervention for infants diagnosed with or at high risk of cerebral palsy (CP). Eight infants aged 5 to 12 months will participate in a structured program that includes an 8-week baseline period without intervention, followed by 16 weeks of intervention, and concluding with an 8-week follow-up period. The intervention involves parents implementing standing and walking practices with body-weight support to promote motor development during a critical growth phase. The goal is to optimize future walking outcomes for these infants.
Who should consider this trial
Good fit: Ideal candidates are infants aged 5 to 12 months who have been diagnosed with cerebral palsy or are at high risk based on specific clinical criteria.
Not a fit: Patients with prenatal substance abuse, congenital malformations, or significant sensory impairments may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could significantly improve walking outcomes for infants at risk of cerebral palsy.
How similar studies have performed: While this approach is innovative, similar interventions targeting early motor development in infants with CP have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Los Angeles, California
- University of Southern California — Los Angeles, California, United States (RECRUITING)
Study contacts
- Principal investigator: Barbara Sargent, PhD, PT — University of Southern California, Division of Biokinesiology and Physical Therapy
- Study coordinator: Barbara Sargent, PhD, PT
- Email: bsargent@pt.usc.edu
- Phone: 323-442-4823
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cerebral Palsy, Infant