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

NCT ID: NCT05781438

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-26
• Study Completion Date: 2026-12-31

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.

Detailed Description

Seventy percent of children with cerebral palsy (CP) will walk, yet walking occurs much later than typically-developing children and may require use of a walker or crutches. The walking impairment is caused by an early lesion to the motor areas of the brain which disrupts the formation of appropriate neural connections, specifically projections of the corticospinal tract from the motor cortex to spinal cord motor circuits. The critical period of lower extremity neuromotor development, when intervention is expected to be most effective, begins before 12 months of age with the establishment of appropriate spinal connections and extends to 2 years of age with the presence of mature myelin in the corticospinal tract at the lumbar level. Based on this research, we propose that to optimize future walking outcomes of individuals with CP, it is critical to promote standing and walking practice during infancy before the age of 12 months.

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 CP. Eight infants with or at high risk of CP will enter the study at 5 to 12-months of age. All infants will participate in 3 conditions: 8-weeks no intervention baseline, 16-weeks intervention, and 8-weeks no intervention follow-up. During the intervention weeks, parents will implement the in-home intensive standing and walking intervention with body-weight support 5 days/week for 30-60 min/day, with weekly telehealth calls and monthly home visits to progress the program. The body-weight support system allows infants to independently explore a 9 by 9-foot space in standing without physical assist from their parents or other adults.

Outcomes will be measured at baseline, monthly throughout the 8 month study, and at 2 years of age. Feasibility of implementing the interventions will be assessed. Secondary outcomes will include standardized assessments of motor, cognitive, and language development of the infants.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

In-home standing and walking intervention

Intervention Type: 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.

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 5 Months
• Maximum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

California Physical Therapy Association

UNKNOWN

Sponsor Role: collaborator

Cerebral Palsy Foundation

UNKNOWN

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Barbara Sargent

Associate Professor of Clinical Physical Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Barbara Sargent, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

University of Southern California, Division of Biokinesiology and Physical Therapy

Locations

University of Southern California

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Barbara Sargent, PhD, PT

Role: CONTACT

bsargent@pt.usc.edu

323-442-4823

Stacey C Dusing, PhD, PT

Role: CONTACT

stacey.dusing@pt.usc.edu

323-442-1022

Facility Contacts

Barbara Sargent, PT, PhD

Role: primary

bsargent@pt.usc.edu

323-442-4823

Stacey Dusing, PT, PhD

Role: backup

Stacey.dusing@pt.usc.edu

323-442-1022

Other Identifiers

UP-22-00866

Identifier Type: -

Identifier Source: org_study_id