Recruiting

Observational Study

Sponsor:

University of Southern California

Code:

NCT05781438

Conditions

Cerebral Palsy

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Not accepted

Interventions

In-home standing and walking intervention

Study Details

Brief summary:

The purpose of this study is to evaluate the feasibility and begin to evaluate the effect of an intensive in-home standing and walking intervention for infants with or at high risk of cerebral palsy.

Conditions

Cerebral Palsy

Study ID

NCT05781438

Start date

Mar 26, 2023

Status verified date

Jun, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

8 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: In-home standing and walking intervention

Infants will participate in the in-home standing and walking intervention for 16 weeks. In addition, infants will continue with any intervention in the community recommended by their health care team.

Interventions

In-home standing and walking intervention

Parents/legal guardians will be educated on and provided an activity booklet on intensive standing and walking play activities for their infant in a 9 by 9 foot body-weight support system (BWS). Activities include: squatting play at a couch or table, cruising along and between furniture, walking with a push toy or with one or two hands held, walking without support, and kicking and throwing a soft ball.

For 16 weeks, parents/legal guardians will be encouraged to implement the parent-led, intensive standing and walking intervention using BWS for at least 5 days/week for 30-60 min/day, with weekly telehealth calls and monthly home visits to coach parents in identifying key activities and progressing the program.

Primary outcome measure

  • Feasibility of the in-home standing and walking intervention [ Time Frame: 4 months ]

Central Contacts and Locations

Central contacts

Barbara Sargent, PhD, PT

323-442-4823bsargent@pt.usc.edu

Stacey C Dusing, PhD, PT

323-442-1022stacey.dusing@pt.usc.edu

Locations

University of Southern California

Recruiting

Los Angeles, California, United States, 90089

Contacts

Barbara Sargent, PT, PhD

323-442-4823bsargent@pt.usc.edu

Stacey Dusing, PT, PhD

323-442-1022Stacey.dusing@pt.usc.edu

More Information

Sponsor

University of Southern California

Last update posted

Jun 26, 2025

Last verified

Jun, 2025

Keywords

  • Infant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Southern California on 2025-06-26.