Cerebral PalsyNCT04684576
Early Powered Mobility for Toddlers With Cerebral Palsy Using the Permobil® Explorer Mini and a Modified Ride-On Car
A study testing Permobil Explorer Mini and Modified Ride-On Car in people with Cerebral Palsy, run by University of Washington at 3 sites in United States.
Trial summary
The use of powered mobility devices for young children with cerebral palsy (CP) has been gaining traction, with evidence that the use of powered mobility at young ages complements (rather than detracts from) other interventions focused on more traditional mobility skills such as crawling and walking. Read more about this study
- Who is it for?
- Ages 12 to 36 months
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Permobil Explorer Mini and Modified Ride-On Car
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Apr 2021to 20 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The child will:
- be between 12-36 months old;
- have a medical diagnosis of CP with any level (I-V) of associated motor ability according to the Gross Motor Function Classification System (GMFCS) or be at risk for CP according to birth history and current developmental status;
- be able to attain a seated position with or without support;
- be able to tolerate upright sitting with or without support while moving through space for 30 minutes;
- live in a household where English is spoken proficiently.
Show all 9Show fewer
- Adults will:
- be 18 years or older and be the legal caregiver for the child participant;
- demonstrate proficiency in English. Inclusion criteria will be secured via caregiver report using screening questions.
Who cannot join
- Child will be excluded if:
- they have not been given a medical diagnosis of CP or are not at risk for CP (per parent report of birth history and current developmental status);
- if they cannot attain a seated position with or without support;
- if they cannot tolerate upright sitting with or without support for 30 minutes;
- Adult caregivers will be excluded if:
- they are not proficient in English (determined per screening process).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Oregon State University
Corvallis, Oregon, 97330
Grand Valley State University
Grand Rapids, Michigan, 49503
University of Washington
Seattle, Washington, 98028
About this study
Official title: Early Powered Mobility for Toddlers With Cerebral Palsy: A Comparative Case Series of the Permobil® Explorer Mini and a Modified Ride-On Car
The use of powered mobility devices for young children with cerebral palsy (CP) has been gaining traction, with evidence that the use of powered mobility at young ages complements (rather than detracts from) other interventions focused on more traditional mobility skills such as crawling and walking. This study will collect preliminary data (both numeric and opinion/perception data) to investigate device use patterns, caregiver perceptions, and developmental outcomes of children with CP as families are introduced to two early powered mobility interventions: the Permobil® Explorer Mini, and a modified ride-on toy car.
Read the detailed description
Overview:
This study will examine how early powered mobility devices impact the lives of children with cerebral palsy (CP) and their families. Investigators will compare a modified ride-on car to one specifically designed for children 12-36 months with disabilities to understand how the early introduction of these devices affects the child's developmental outcomes, examine device use patterns (frequency, duration, and environment) and evaluate caregiver perceptions of a motorized mobility device. Research comparing these devices in natural environments will provide critical data regarding early powered mobility for children with CP.
Abstract:
Children diagnosed with CP, or children being monitored for signs and symptoms related to CP, make up the largest group of children affected by a disability. Across the lifespan, many people with CP use powered mobility devices such as scooters and wheelchairs to support their mobility and participation in home and community settings. However, the trend in early intervention has been to delay use of devices until efforts to promote independent walking are exhausted, despite strong evidence that supports early use of powered mobility to assist with participation in everyday activities. Additionally, research has indicated the use of powered mobility complements (rather than detracts from) other interventions focused on more traditional self-initiated mobility skills such as crawling and walking.
Study investigators have been involved in an international mobility and socialization program called Go Baby Go, which provides safety and accessibility modifications to commercially available toy ride-on cars. In compliment to this work, their colleagues at Permobil® have designed and recently received FDA clearance for the Explorer Mini, a powered mobility device specifically designed for children 12-36 months with disabilities such as CP to enhance their mobility and environmental exploration. Both these early powered mobility options offer functional, aesthetic, and affordable alternatives for children and families to fill a gap left by traditional powered wheelchairs.
Investigators are using a mixed-methods study to investigate the device use patterns, caregiver perceptions, and developmental outcomes of children with CP and their families. This represents the first opportunity to compare the novel device (Explorer mini) with a modified ride-on car, which has also been customized to support early self-initiated mobility in a socially inviting way. Taken together, research comparing these devices in natural environments can add critical data to the evidence base supporting early powered mobility for children with CP as a part of using multiple devices for mobility to care for those with disabilities across the lifespan. This study will also create a pilot data set from which to secure future large-scale funding to assess a wider variety of mobility devices with multiple trial sites across the country. Establishing and improving this evidence base for children with CP and their families is essential to ensure equitable access to mobility and participation experiences across the lifespan using a range of technologies to support access and facilitate achievement of key developmental skills. The aims are to: 1) Evaluate a powered mobility intervention to promote developmental, activity and participation outcomes of young children with CP; and 2) Compare the use patterns (frequency, duration, environment) of two powered mobility options: The Explorer Mini and a modified ride-on car.
- Conditions
- Cerebral Palsy
- Being tested
- Permobil Explorer Mini, Modified Ride-On Car
- Keywords
- At risk for cerebral palsy
- Medical subject headings
- Cerebral Palsy
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 new pediatric powered wheelchair that has been cleared by the FDA. The Explorer Mini will be provided for 8-weeks, and families will be provided with suggested use frequencies and provided with support for implementing the device intervention with their child.
Modified Ride-On CarDevice
Access to commercial powered mobility devices is often limited by funding or size. Many families use toy ride-on cars for early mobility, which can be easily adapted for safety and accessibility. The modified ride-on car will be provided for 8-weeks, and families will be provided with suggested use frequencies and provided with support for implementing the device intervention with their child.
| Study group | Role | What they receive |
|---|---|---|
| Explorer Mini First (AB Arm) | Experimental | Children randomized into this arm will first trial a Permobil Explorer Mini powered mobility device over an 8-week intervention period, then trial a modified ride-on car over a second 8-week intervention period in their home and community environments. Receives: Device: Permobil Explorer Mini; Device: Modified Ride-On Car |
| Modified Ride On Car First (BA Arm) | Active comparator | Children randomized into this arm will first trial a modified ride-on car over an 8-week intervention period, then trial a Permobil Explorer Mini powered mobility device over a second 8-week intervention period in their home and community environments. Receives: Device: Permobil Explorer Mini; Device: Modified Ride-On Car |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Child Developmental Outcomes From Baseline to 8 Weeks
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: At baseline, after first 8-week device intervention period
Change in Child Developmental Outcomes From 8 Weeks to 16 Weeks
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: After second 8-week device intervention period.
Change in Child Developmental Outcomes From Baseline to 16 Weeks
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: At baseline, and after the second 8-week device period.
Change in Child Participation and Recreational Activities From Baseline to 8 Weeks
Child Engagement in Daily Life (CEDL). The CEDL is a caregiver survey tool that assesses participation in family and recreational activities and uses a 5-point Likert scale to assess frequency of participation and enjoyment of participation. The CEDL also assesses participation in self-care behaviors and uses a 5-point Likert scale to assess the degree to which the child participates in the daily self-care activities of feeding, dressing, bathing, and toileting. Scores are reported for the first section, Frequency of Participation, and the third section, Participation in Self-Care, using scaled scores validated with individuals with CP, which range between 0-100. For the remaining section (Enjoyment of Participation), only raw scores are reported, with ranges of 11-55, respectively. Higher or increased scores indicate better outcomes on all scales.
Measured: At baseline, after first 8-week device intervention period.
Change in Child Participation and Self-care Activities From 8 Weeks to 16 Weeks
Child Engagement in Daily Life (CEDL). The CEDL is a caregiver survey tool that assesses participation in family and recreational activities and uses a 5-point Likert scale to assess frequency of participation and enjoyment of participation. The CEDL also assesses participation in self-care behaviors and uses a 5-point Likert scale to assess the degree to which the child participates in the daily self-care activities of feeding, dressing, bathing, and toileting. Scores are reported for the first section, Frequency of Participation, and the third section, Participation in Self-Care, using scaled scores validated with individuals with CP, which range between 0-100. For the remaining section (Enjoyment of Participation), only raw scores are reported, with ranges of 11-55, respectively. Higher or increased scores indicate better outcomes on all scales.
Measured: After second 8-week device intervention period.
Change in Child Participation and Self Care Outcomes From Baseline to 16 Weeks
Child Engagement in Daily Life (CEDL). The CEDL is a caregiver survey tool that assesses participation in family and recreational activities and uses a 5-point Likert scale to assess frequency of participation and enjoyment of participation. The CEDL also assesses participation in self-care behaviors and uses a 5-point Likert scale to assess the degree to which the child participates in the daily self-care activities of feeding, dressing, bathing, and toileting. Scores are reported for the first section, Frequency of Participation, and the third section, Participation in Self-Care, using scaled scores validated with individuals with CP, which range between 0-100. For the remaining section (Enjoyment of Participation), only raw scores are reported, with ranges of 11-55, respectively. Higher or increased scores indicate better outcomes on all scales.
Measured: At baseline, and after the second 8-week device period.
Secondary outcomes (2)
Acceptability, Intervention Appropriateness, and Feasibility of The Explorer Mini
Caregivers will complete a 3-measure perceptual implementation outcome survey. All measures are 4-item, 5-point likert-scale surveys. The minimum value is 1 and the maximum value is 5 per measure. The Acceptability of Intervention Measure (AIM) is designed to measure how receptive stakeholders are to adopting an intervention, the Intervention Appropriateness Measure (IAM) is designed to measure suitability of the intervention in a given environment or circumstance, and the Feasibility of Intervention Measure (FIM) is designed to measure how possible and likely stakeholders are to adopt an intervention. Higher ratings indicate better outcomes, in this case greater acceptability, intervention appropriateness, and feasibility of adoption. Mean rankings are reported out of a 5 point scale for each section.
Measured: After first 8-week device intervention period.
Acceptability, Intervention Appropriateness, and Feasibility of the Ride-On Car
Caregivers will complete a 3-measure perceptual implementation outcome survey. All measures are 4-item, 5-point likert-scale surveys. The minimum score is 1 and the maximum score is 5 per measure. The Acceptability of Intervention Measure (AIM) is designed to measure how receptive stakeholders are to adopting an intervention, the Intervention Appropriateness Measure (IAM) is designed to measure suitability of the intervention in a given environment or circumstance, and the Feasibility of Intervention Measure (FIM) is designed to measure how possible and likely stakeholders are to adopt an intervention. Higher ratings indicate better outcomes, in this case greater acceptability, intervention appropriateness, and feasibility of adoption. Mean rankings are reported out of a total maximum of 5 for each section.
Measured: After second 8-week device intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start15 Apr 2021
- Primary completion20 May 2022
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Crossover
- Model description
- A mixed-methods, randomized, counterbalanced 2x2 crossover intervention study. Condition A is 8-weeks of Permobil Explorer Mini Use, and Condition B is 8-weeks of modified ride-on car use.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon State University, Grand Valley State University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Heather Feldner, University of Washington
- Investigators
- Heather A Feldner, PT, PhD, PCS, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04684576
- Sponsor's protocol ID
- STUDY00011386
- Other IDs
- P2CHD101912
- Status last verified
- Aug 2023
- First submitted
- 4 Dec 2020
- Last updated
- 4 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified IPD, including score report data from participation and developmental measures and device use reports will be made available to other researchers upon request and reported in aggregate on clinicaltrials.gov per NIH funding requirements.
Publications
Sloane BM, Hoffman M, Logan SW, Kenyon LK, Steele KM, Feldner HA. Comparison of three tracking methods to assess usage of two pediatric powered mobility devices for young children with cerebral palsy. Assist Technol. 2026 Sep;38(5):465-474. doi: 10.1080/10400435.2025.2577390. Epub 2025 Nov 4.
PubMed 42659039
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Powered Mobility for Toddlers With Cerebral Palsy: A Comparative Case Series of the Permobil® Explorer Mini and a Modified Ride-On Car
- ClinicalTrials.gov ID
- NCT04684576
- Acronym / sponsor ID
- STUDY00011386
- Conditions
- Cerebral Palsy
- Keywords
- At risk for cerebral palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Oregon State University, Grand Valley State University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 24 Dec 2020 (actual)
- Results
- Posted 4 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The use of powered mobility devices for young children with cerebral palsy (CP) has been gaining traction, with evidence that the use of powered mobility at young ages complements (rather than detracts from) other interventions focused on more traditional mobility skills such as crawling and walking. This study will collect preliminary data (both numeric and opinion/perception data) to investigate device use patterns, caregiver perceptions, and developmental outcomes of children with CP as families are introduced to two early powered mobility interventions: the Permobil® Explorer Mini, and a modified ride-on toy car.
Detailed description
Overview:
This study will examine how early powered mobility devices impact the lives of children with cerebral palsy (CP) and their families. Investigators will compare a modified ride-on car to one specifically designed for children 12-36 months with disabilities to understand how the early introduction of these devices affects the child's developmental outcomes, examine device use patterns (frequency, duration, and environment) and evaluate caregiver perceptions of a motorized mobility device. Research comparing these devices in natural environments will provide critical data regarding early powered mobility for children with CP.
Abstract:
Children diagnosed with CP, or children being monitored for signs and symptoms related to CP, make up the largest group of children affected by a disability. Across the lifespan, many people with CP use powered mobility devices such as scooters and wheelchairs to support their mobility and participation in home and community settings. However, the trend in early intervention has been to delay use of devices until efforts to promote independent walking are exhausted, despite strong evidence that supports early use of powered mobility to assist with participation in everyday activities. Additionally, research has indicated the use of powered mobility complements (rather than detracts from) other interventions focused on more traditional self-initiated mobility skills such as crawling and walking.
Study investigators have been involved in an international mobility and socialization program called Go Baby Go, which provides safety and accessibility modifications to commercially available toy ride-on cars. In compliment to this work, their colleagues at Permobil® have designed and recently received FDA clearance for the Explorer Mini, a powered mobility device specifically designed for children 12-36 months with disabilities such as CP to enhance their mobility and environmental exploration. Both these early powered mobility options offer functional, aesthetic, and affordable alternatives for children and families to fill a gap left by traditional powered wheelchairs.
Investigators are using a mixed-methods study to investigate the device use patterns, caregiver perceptions, and developmental outcomes of children with CP and their families. This represents the first opportunity to compare the novel device (Explorer mini) with a modified ride-on car, which has also been customized to support early self-initiated mobility in a socially inviting way. Taken together, research comparing these devices in natural environments can add critical data to the evidence base supporting early powered mobility for children with CP as a part of using multiple devices for mobility to care for those with disabilities across the lifespan. This study will also create a pilot data set from which to secure future large-scale funding to assess a wider variety of mobility devices with multiple trial sites across the country. Establishing and improving this evidence base for children with CP and their families is essential to ensure equitable access to mobility and participation experiences across the lifespan using a range of technologies to support access and facilitate achievement of key developmental skills. The aims are to: 1) Evaluate a powered mobility intervention to promote developmental, activity and participation outcomes of young children with CP; and 2) Compare the use patterns (frequency, duration, environment) of two powered mobility options: The Explorer Mini and a modified ride-on car.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A mixed-methods, randomized, counterbalanced 2x2 crossover intervention study. Condition A is 8-weeks of Permobil Explorer Mini Use, and Condition B is 8-weeks of modified ride-on car use.
| Arm | Type | Receives |
|---|---|---|
| Explorer Mini First (AB Arm) | Experimental | Device: Permobil Explorer Mini, Device: Modified Ride-On CarChildren randomized into this arm will first trial a Permobil Explorer Mini powered mobility device over an 8-week intervention period, then trial a modified ride-on car over a second 8-week intervention period in their home and community environments. |
| Modified Ride On Car First (BA Arm) | Active comparator | Device: Permobil Explorer Mini, Device: Modified Ride-On CarChildren randomized into this arm will first trial a modified ride-on car over an 8-week intervention period, then trial a Permobil Explorer Mini powered mobility device over a second 8-week intervention period in their home and community environments. |
Who may qualify
- Ages
- 12 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- be between 12-36 months old;
- have a medical diagnosis of CP with any level (I-V) of associated motor ability according to the Gross Motor Function Classification System (GMFCS) or be at risk for CP according to birth history and current developmental status;
- be able to attain a seated position with or without support;
- be able to tolerate upright sitting with or without support while moving through space for 30 minutes;
- live in a household where English is spoken proficiently.
Key exclusion criteria (6 listed)
- they have not been given a medical diagnosis of CP or are not at risk for CP (per parent report of birth history and current developmental status);
- if they cannot attain a seated position with or without support;
- if they cannot tolerate upright sitting with or without support for 30 minutes;
- they are not proficient in English (determined per screening process).
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 new pediatric powered wheelchair that has been cleared by the FDA. The Explorer Mini will be provided for 8-weeks, and families will be provided with suggested use frequencies and provided with support for implementing the device intervention with their child. | Device | Explorer Mini First (AB Arm), Modified Ride On Car First (BA Arm) |
| Modified Ride-On CarAccess to commercial powered mobility devices is often limited by funding or size. Many families use toy ride-on cars for early mobility, which can be easily adapted for safety and accessibility. The modified ride-on car will be provided for 8-weeks, and families will be provided with suggested use frequencies and provided with support for implementing the device intervention with their child. | Device | Explorer Mini First (AB Arm), Modified Ride On Car First (BA Arm) |
Primary outcome
Change in Child Developmental Outcomes From Baseline to 8 Weeks
Time frame: At baseline, after first 8-week device intervention period
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.
Change in Child Developmental Outcomes From 8 Weeks to 16 Weeks
Time frame: After second 8-week device intervention period.
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.
Change in Child Developmental Outcomes From Baseline to 16 Weeks
Time frame: At baseline, and after the second 8-week device period.
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.
Change in Child Participation and Recreational Activities From Baseline to 8 Weeks
Time frame: At baseline, after first 8-week device intervention period.
Child Engagement in Daily Life (CEDL). The CEDL is a caregiver survey tool that assesses participation in family and recreational activities and uses a 5-point Likert scale to assess frequency of participation and enjoyment of participation. The CEDL also assesses participation in self-care behaviors and uses a 5-point Likert scale to assess the degree to which the child participates in the daily self-care activities of feeding, dressing, bathing, and toileting. Scores are reported for the first section, Frequency of Participation, and the third section, Participation in Self-Care, using scaled scores validated with individuals with CP, which range between 0-100. For the remaining section (Enjoyment of Participation), only raw scores are reported, with ranges of 11-55, respectively. Higher or increased scores indicate better outcomes on all scales.
Change in Child Participation and Self-care Activities From 8 Weeks to 16 Weeks
Time frame: After second 8-week device intervention period.
Child Engagement in Daily Life (CEDL). The CEDL is a caregiver survey tool that assesses participation in family and recreational activities and uses a 5-point Likert scale to assess frequency of participation and enjoyment of participation. The CEDL also assesses participation in self-care behaviors and uses a 5-point Likert scale to assess the degree to which the child participates in the daily self-care activities of feeding, dressing, bathing, and toileting. Scores are reported for the first section, Frequency of Participation, and the third section, Participation in Self-Care, using scaled scores validated with individuals with CP, which range between 0-100. For the remaining section (Enjoyment of Participation), only raw scores are reported, with ranges of 11-55, respectively. Higher or increased scores indicate better outcomes on all scales.
Change in Child Participation and Self Care Outcomes From Baseline to 16 Weeks
Time frame: At baseline, and after the second 8-week device period.
Child Engagement in Daily Life (CEDL). The CEDL is a caregiver survey tool that assesses participation in family and recreational activities and uses a 5-point Likert scale to assess frequency of participation and enjoyment of participation. The CEDL also assesses participation in self-care behaviors and uses a 5-point Likert scale to assess the degree to which the child participates in the daily self-care activities of feeding, dressing, bathing, and toileting. Scores are reported for the first section, Frequency of Participation, and the third section, Participation in Self-Care, using scaled scores validated with individuals with CP, which range between 0-100. For the remaining section (Enjoyment of Participation), only raw scores are reported, with ranges of 11-55, respectively. Higher or increased scores indicate better outcomes on all scales.
2 secondary outcomes
Acceptability, Intervention Appropriateness, and Feasibility of The Explorer Mini
Time frame: After first 8-week device intervention period.
Acceptability, Intervention Appropriateness, and Feasibility of the Ride-On Car
Time frame: After second 8-week device intervention period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42659039Sloane BM, Hoffman M, Logan SW, Kenyon LK, Steele KM, Feldner HA. Comparison of three tracking methods to assess usage of two pediatric powered mobility devices for young children with cerebral palsy. Assist Technol. 2026 Sep;38(5):465-474. doi: 10.1080/10400435.2025.2577390. Epub 2025 Nov 4.
- Individual participant dataSharing planned: Yes. De-identified IPD, including score report data from participation and developmental measures and device use reports will be made available to other researchers upon request and reported in aggregate on clinicaltrials.gov per NIH funding requirements.
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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. This study is not recruiting at the moment.
Heather A Feldner, PT, PhD, PCS principal investigator
University of Washington
3 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 Modified Ride-On Car in people with Cerebral Palsy, run by University of Washington at 3 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 9 inclusion and 6 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: finished, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Yes. Results are posted in the registry (first posted 4 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Child Developmental Outcomes From Baseline to 8 Weeks (time frame: At baseline, after first 8-week device intervention period). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04684576, which also lists 1 linked publication.
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 4 Aug 2023.