DRIVE
Sponsor study identifier
Secondary identifiers
interventional
48
1 country
2
Study Start
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
September 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 8, 2026
Actual (reported)October 15, 2026
Actual (reported)January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Bayley Scales of Infant Development-4 (BSID-4)
The Bayley Scales of Infant Development (BSID), 4th Edition is an internationally recognized, norm referenced set of tests designed to assess developmental domains from one month to 42 months of age. This BSID-IV assessment includes Cognitive, Receptive Communication, Expressive Communication, Gross Motor, and Fine Motor subscales. Each subscale has unique score value maximums, but on all subscales, higher scores mean a better outcome. Raw score scales are in increments of 1 and range from: Cognitive (0-81); Receptive Communication (0-42); Expressive Communication (0-37); Gross Motor (0-58); Fine Motor (0-46). Mean changes in Raw Scores are reported for each domain in this summary.
Baseline, post-intervention (12 weeks), and 6-month follow-up
Gross Motor Function Measure-66 (GMFM-66)
Baseline, post-intervention (12 weeks), and 6-month follow-up
Canadian Occupational Performance Measure (COPM)
Baseline, post-intervention (12 weeks), and 6-month follow-up
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.
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.
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.
Grand Valley State University
Grand Rapids, Michigan, 49503, United States
Oregon State University
Portland, Oregon, 97201, United States
Heather Feldner, PhD
University of Washington
First Submitted
October 8, 2026
First Posted
October 15, 2026
Study Start
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Sampling Therapeutic Effects and Progress in Cerebral Palsy (STEP-CP)
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.
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Primary Completion
September 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 15, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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