RecruitingNot ApplicableNCT05781438

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

Sponsor

University of Southern California

Enrollment

8 participants

Start Date

Mar 26, 2023

Study Type

INTERVENTIONAL

Conditions

Cerebral Palsy

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.

Eligibility

Min Age: 5 MonthsMax Age: 2 Years

Inclusion Criteria5

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 Criteria7

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.

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Interventions

BEHAVIORALIn-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.