Dynamic, Real-world Learning, Innovative Mobility, and Versatile Exploration (DRIVE): Evaluating a Dose-matched Developmental Powered Mobility Intervention for Young Children With Cerebral Palsy

University of Washington

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

Age range: 1–2 years
Sex: All
Healthy volunteers: No

Detailed 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…

Interventions

Device
Permobil Explorer Mini
The use of powered mobility devices for young children with cerebral palsy is increasingly recommended. The Permobil Explorer Mini is a pediatric powered wheelchair specifically designed for children 12-36 months of age that has been cleared by the FDA. The device can be driven in seated or supported standing and features a midline fixed joystick, can travel at 5 speeds, up to 1.5 mph maximum, and has a 360 degree turn radius. Specific training strategies for each child will be selected based on the learning phase of each child and associated facilitating strategies. Activities may include exploring the joystick and tray, exploring movement in different directions, or moving to and from specific people or places. Devices will not be kept at participant homes between visits to ensure dosing adherence.
Other
MORE-PT
MORE-PT is comprised of traditional early intervention activities focused on strengthening, musculoskeletal alignment, and repetition of movement, and represents actual practice in early intervention. It is the only usual care intervention that has been standardized and fidelity-tested with this population in previous research, facilitating a rigorous dose-matched design and effectiveness comparison with DPM. Activities may include stretching and strengthening exercises, handling and postural cueing, and functional activities such as rolling, sit to stand, and crawling or cruising as appropriate.

Locations (2)

Grand Valley State University
Grand Rapids, Michigan
kenyonli@gvsu.edu
Oregon State University
Portland, Oregon
sam.logan@oregonstate.edu

Summary

Eligibility

Age range

1–2 years

Sex

All

Healthy volunteers

Detailed criteria

Interventions

Device

Permobil Explorer Mini

The use of powered mobility devices for young children with cerebral palsy is increasingly recommended. The Permobil Explorer Mini is a pediatric powered wheelchair specifically designed for children 12-36 months of age that has been cleared by the FDA. The device can be driven in seated or supported standing and features a midline fixed joystick, can travel at 5 speeds, up to 1.5 mph maximum, and has a 360 degree turn radius. Specific training strategies for each child will be selected based on the learning phase of each child and associated facilitating strategies. Activities may include exploring the joystick and tray, exploring movement in different directions, or moving to and from specific people or places. Devices will not be kept at participant homes between visits to ensure dosing adherence.

Other

MORE-PT

MORE-PT is comprised of traditional early intervention activities focused on strengthening, musculoskeletal alignment, and repetition of movement, and represents actual practice in early intervention. It is the only usual care intervention that has been standardized and fidelity-tested with this population in previous research, facilitating a rigorous dose-matched design and effectiveness comparison with DPM. Activities may include stretching and strengthening exercises, handling and postural cueing, and functional activities such as rolling, sit to stand, and crawling or cruising as appropriate.