An interventional study of Permobil Explorer Mini and MORE-PT in Cerebral Palsy, sponsored by University of Washington. Not yet recruiting at 2 sites in United States. Open to participants aged 12 Months to 33 Months. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by University of Washington · Not applicable, Interventional, and Treatment
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.
1,891 studies on the registry are indexed under Cerebral Palsy; 439 are open to participants now.
This study's planned enrollment of 48 is above the median of 34 across 1,396 interventional studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →University of Washington is the lead sponsor of 1,431 studies on the registry; 226 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 136 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The child will:
The adult will:
Exclusion Criteria:
The child will be excluded if:
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.
Device: Permobil Explorer Mini
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.
Other: MORE-PT
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 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.
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.
Time frame: Baseline, post-intervention (12 weeks), and 6-month follow-up
Gross Motor Function Measure-66 (GMFM-66)
The GMFM-66 is a criterion-referenced measure designed to assess change in gross motor function over time and response to intervention in children with CP from 5 months to 16 years across 5 subscales: Lying and Rolling; Sitting; Crawling and Kneeling; Standing; and Walking, Running, Jumping. Items within each subscale are scored individually using a 4-point ordinal scale (0 to 3), which is then converted into an interval-level total score using the Gross Motor Ability Estimator software.
Time frame: Baseline, post-intervention (12 weeks), and 6-month follow-up
Canadian Occupational Performance Measure (COPM)
The COPM is an individualized, family-centered assessment that used a semi-structured interview format to identify activities and issues that are important for a child and family. After identifying and prioritizing their top 5 activity limitations, caregivers rank their perceptions of their child's current level of performance and current level of satisfaction with this performance on a 1-10 scale. Averages are calculated for both performance and satisfaction with performance. A change of 2 or more points for either indicates a clinically significant improvement.
Time frame: Baseline, post-intervention (12 weeks), and 6-month follow-up
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Sep 2030, 44 months later.
Of 882 non-industry interventional studies with no phase under Cerebral Palsy, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's planned 44 months is above that.
Counting every sponsor, half of 900 studies reached it within 12 months; a quarter within 5 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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