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In-home Standing and Walking Intervention for Infants at Risk of Cerebral Palsy

This study is looking at how practical and effective an in-home standing and walking intervention is for infants who have, or are at high risk of developing, cerebral palsy (CP). The intervention involves parents learning and doing intensive standing and walking play activities with their infant using a special body-weight support system. We want to see if this approach is feasible and if it helps infants develop walking skills earlier. You might be able to join if your infant is between 5 months and 2 years old and has been diagnosed with CP or has specific brain imaging findings that put them at high risk for CP. The main goal is to see if this intervention can be successfully used at home over 4 months. The study is currently unclear on its recruitment status.

Study design
This is an interventional study with 8 participants. All infants will go through a period without intervention, then 16 weeks of the intervention, followed by another period without intervention.
What's involved
Your infant will participate in 8 weeks of no intervention, 16 weeks of the in-home standing and walking intervention, and then 8 weeks of no intervention follow-up.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 8 weeks after the intervention period.

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NCT05781438

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

Recruiting
NAAges 5–2Interventional
University of Southern California
~8 participants
Updated 2025-06-26 on ClinicalTrials.gov
What's tested:In-home standing and walking intervention

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of the in-home standing and walking intervention
Measured over 4 months

Conditions

Cerebral Palsy

Explore related trials

Cerebral Palsy

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Barbara Sargent, PhD, PT · PRINCIPAL_INVESTIGATOR · University of Southern California, Division of Biokinesiology and Physical Therapy

Who to contact

Barbara Sargent, PhD, PT
[email protected]
323-442-4823
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Feasibility of the in-home standing and walking intervention4 months

    Feasibility will be quantified by: parent survey of the: (a) infants' level of enjoyment during the intervention, (b) ease of use of the body-weight support system, (c) time participating in intervention, (d) time to put child in and take child out of the body-weight support, (e) perception of the effect of the intervention on the infant's motor skills, (f) perception of the effects of the intervention on the infant's non-motor skills (cognition, social, language), (g) overall perception of intervention as beneficial. The parent survey is on a likert scale from 1 to 5; a higher score denotes a better outcome.