Clinical trial NCT05781438: Feasibility of an In-home Standing and Walking Intervention for Infants With and at High Risk of Cerebral Palsy
Official title: Feasibility of an In-home Standing and Walking Intervention for Infants With and at High Risk of Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Keywords: Infant
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: California Physical Therapy Association
name: Cerebral Palsy Foundation
First posted: 2023-03-23
Enrollment: 8
Sex: ALL
Minimum age (years): 5
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-subject research design
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Feasibility of the in-home standing and walking intervention
timeFrame: 4 months
Secondary outcomes:
measure: Bayley Scales of Infant and Toddler Development, 4th edition (Bayley-4)
timeFrame: 2 years
measure: Gross Motor Function Measure (GMFM-88)
timeFrame: 2 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California, Division of Biokinesiology and Physical Therapy
name: Barbara Sargent, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References: