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NCT07876219
Dynamic, Real-world Learning, Innovative Mobility, and Versatile Exploration (DRIVE): Evaluating a Dose-matched Developmental Powered Mobility Intervention for Young Children With Cerebral Palsy
Conditions: Cerebral Palsy
Sex: All
Ages: 12 Months – 33 Months
Healthy volunteers: No
Phase: NA
Enrollment: 48
Sponsor: University of Washington
Location: Grand Valley State University Grand Rapids Michigan
Summary
The goal of this clinical trial is to understand the effects of developmental powered mobility intervention on global development, gross motor function, and activity performance outcomes in 48 young children (ages 1-2 years) with cerebral palsy (CP). The main question it aims to answer is:
Does the developmental powered mobility intervention produce greater improvements in global development and activity performance outcomes in young children with CP?
How will the developmental powered mobility intervention effect gross motor function?
Researchers will compare the developmental powered mobility (DPM) intervention to usual care physical therapy focused on movement, orientation, repetition, and exercise (MORE-PT) to see if DPM produces greater improvements in outcomes without impeding gross motor function.
Child Participants will:
Receive either DPM or MORE-PT twice weekly for 12 weeks in the home setting.
Complete assessments with the interventionist before and after the 12-week intervention and at a 6-month follow-up visit.
Caregiver participants will: Track outside therapies and any outside assistive device use completed during the intervention, in a weekly log.
Eligibility Criteria
Inclusion Criteria:
The child will:
* be 12-33 months old at study enrollment
* have a medical diagnosis of cerebral palsy or have high likelihood of a future cerebral palsy diagnosis based on birth history or current developmental status, with motor abilities consistent with the Gross Motor Function Classification System (GMFCS) Levels II-IV
* be able to maintain a sitting position with or without support while moving through space for 30 minutes
* live in a household where English or Spanish are spoken proficiently
The adult will:
* be 18 years or older and be the legal caregiver for the child participant
* demonstrate proficiency in English or Spanish. Inclusion criteria will be secured via caregiver report using screening questions.
Exclusion Criteria:
The child will be excluded if:
* they are greater than 33 months of age at enrollment (to ensure they complete the 12-week intervention prior to reaching the upper age recommendation for the Explorer Mini (36 months)
* they already consistently use a power mobility device in the home
* they do not have motor presentations consistent with GMFCS II-IV
Source: ClinicalTrials.gov (NCT07876219). StuddyBuddy aggregates publicly available trial information.