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

Eligibility Criteria

Sex

ALL

Age

12 Months - 33 Months

Healthy Volunteers

Not accepted

Interventions

• Permobil Explorer Mini — DEVICE
  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.
• MORE-PT — OTHER
  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.

Study Details

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.

Key Dates

First listed

Oct 15, 2026

Start date

Jan 31, 2027

Status verified

Oct 2026

Primary completion

Sep 30, 2030

Completion

Sep 30, 2030

Study Design

Enrollment

48 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Developmental Powered Mobility
  Children randomized to this group will engage in home-based DPM activities using the Explorer Mini device, focusing on three main areas: tool use, exploratory perceptual motor experiences, and goal directed mobility.
• Active Comparator: MORE-PT
  Children randomized to this group will engage in a home-based usual care physical therapy intervention, focusing on movement, orientation, repetition, and exercise-physical therapy.

Primary Outcome Measure

Bayley Scales of Infant Development-4 (BSID-4) [ Time Frame: Baseline, post-intervention (12 weeks), and 6-month follow-up ]

Central Contacts

• Heather Feldner, PhD
  206-543-3721
  [email protected]

Locations (2)

Find similar trials in Grand Rapids, MI

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