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

NCT05781438 | Recruiting

• 1 other identifier: UP-22-00866
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Keywords

Infant

Outcome Measures

Primary Outcomes (1)

• Feasibility of the in-home standing and walking intervention

  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.

  4 months

Secondary Outcomes (2)

• Bayley Scales of Infant and Toddler Development, 4th edition (Bayley-4)

  2 years

• Gross Motor Function Measure (GMFM-88)

  2 years

Study Arms (1)

In-home standing and walking intervention

EXPERIMENTAL

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.

Behavioral: In-home standing and walking intervention

Interventions

In-home standing and walking intervention BEHAVIORAL

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.

In-home standing and walking intervention

Eligibility Criteria

• Age: 5 Months - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern California: lead
• California Physical Therapy Association: collaborator
• Cerebral Palsy Foundation: collaborator

Study Sites (1)

University of Southern California

Los Angeles, California, 90089, United States

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Barbara Sargent, PhD, PT

  University of Southern California, Division of Biokinesiology and Physical Therapy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara Sargent, PhD, PT

CONTACT

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

Stacey C Dusing, PhD, PT

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Physical Therapy

Model Details: Single-subject research design

Study Record Dates

• First Submitted: December 31, 2022
• First Posted: March 23, 2023
• Study Start: March 26, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)