Cerebral PalsyDRIVENCT07876219
Dynamic, Real-world Learning, Innovative Mobility, and Versatile Exploration (DRIVE): Evaluating a Dose-matched Developmental Powered Mobility Intervention for Young Children With Cerebral Palsy
A study testing Permobil Explorer Mini and MORE-PT in people with Cerebral Palsy, run by University of Washington at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 to 33 months
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Permobil Explorer Mini and MORE-PT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2027to Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 33 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Grand Valley State University
Grand Rapids, Michigan, 49503
Lisa Kenyon, PT, DPT, PhD, PCS, kenyonli@gvsu.edu
Oregon State University
Portland, Oregon, 97201
Sam Logan, PhD, sam.logan@oregonstate.edu
Bethany Sloane, PT, DPT, PhD
About this study
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?
Read more
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.
- Conditions
- Cerebral Palsy
- Being tested
- Permobil Explorer Mini, MORE-PT
- Keywords
- At risk for cerebral palsy, Brain Damage, Chronic Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Cerebral Palsy
- Medical subject headings
- Cerebral Palsy, Brain Injuries, Central Nervous System Diseases, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Permobil Explorer MiniDevice
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-PTOther
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 group | Role | What they receive |
|---|---|---|
| Developmental Powered Mobility | Experimental | 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. Receives: Device: Permobil Explorer Mini |
| MORE-PT | Active comparator | 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. Receives: Other: MORE-PT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, post-intervention (12 weeks), and 6-month follow-up
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline, post-intervention (12 weeks), and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study startJan 2027 (estimated)
- Primary completionSep 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Heather Feldner, University of Washington
- Investigators
- Heather Feldner, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07876219
- Sponsor's protocol ID
- STUDY00025444
- Other IDs
- 1R01HD119180-01A1
- Acronym
- DRIVE
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic, Real-world Learning, Innovative Mobility, and Versatile Exploration (DRIVE): Evaluating a Dose-matched Developmental Powered Mobility Intervention for Young Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07876219
- Acronym / sponsor ID
- DRIVE / STUDY00025444
- Conditions
- Cerebral Palsy
- Keywords
- At risk for cerebral palsy, Brain Damage, Chronic Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jan 2027 (estimated)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 15 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Developmental Powered Mobility | Experimental | Device: Permobil Explorer MiniChildren 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. |
| MORE-PT | Active comparator | Other: MORE-PTChildren randomized to this group will engage in a home-based usual care physical therapy intervention, focusing on movement, orientation, repetition, and exercise-physical therapy. |
Who may qualify
- Ages
- 12 to 33 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
- be 18 years or older and be the legal caregiver for the child participant
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Permobil Explorer MiniThe 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. | Device | Developmental Powered Mobility |
| MORE-PTMORE-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. | Other | MORE-PT |
Primary outcome
Bayley Scales of Infant Development-4 (BSID-4)
Time frame: Baseline, post-intervention (12 weeks), and 6-month follow-up
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.
2 secondary outcomes
Gross Motor Function Measure-66 (GMFM-66)
Time frame: Baseline, post-intervention (12 weeks), and 6-month follow-up
Canadian Occupational Performance Measure (COPM)
Time frame: Baseline, post-intervention (12 weeks), and 6-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Heather Feldner, PhD principal investigator
University of Washington
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Permobil Explorer Mini and MORE-PT in people with Cerebral Palsy, run by University of Washington at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heather Feldner, PhD (206-543-3721, hfeldner@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bayley Scales of Infant Development-4 (BSID-4) (time frame: Baseline, post-intervention (12 weeks), and 6-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.