Trial Outcomes & Findings for Early Powered Mobility for Toddlers With Cerebral Palsy Using the Permobil® Explorer Mini and a Modified Ride-On Car (NCT NCT04684576)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

At baseline, after first 8-week device intervention period

Results posted on

2023-08-04

Participant Flow

Participants were recruited across all three study sites between January and August 2021 via flyers posted to clinical contacts, on study recruitment websites, and on social media.

No enrolled participants were excluded from the study. Enrollment was balanced, 8 participants enrolled at each site. Randomization into groups (AB or BA) to determine order of device use was conducted independently at each site after enrollment.

Participant milestones

Participant milestones
Measure	Explorer Mini First (AB Arm) 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. Permobil Explorer Mini: 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 Car: 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.	Modified Ride On Car First (BA Arm) 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. Permobil Explorer Mini: 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 Car: 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.
Overall Study STARTED	12	12
Overall Study COMPLETED	12	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Early Powered Mobility for Toddlers With Cerebral Palsy Using the Permobil® Explorer Mini and a Modified Ride-On Car

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Explorer Mini First (AB Arm) n=12 Participants 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. Permobil Explorer Mini: 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 Car: 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.	Modified Ride On Car First (BA Arm) n=12 Participants 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. Permobil Explorer Mini: 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 Car: 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.	Total n=24 Participants Total of all reporting groups
Age, Categorical <=18 years	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	22.3 months STANDARD_DEVIATION 7.2 • n=5 Participants	20.9 months STANDARD_DEVIATION 5.8 • n=7 Participants	21.6 months STANDARD_DEVIATION 6.4 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Explorer Mini First (AB Arm) n=12 Participants 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. Permobil Explorer Mini: 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 Car: 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.	Modified Ride On Car First (BA Arm) n=12 Participants 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. Permobil Explorer Mini: 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 Car: 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.
Change in Child Developmental Outcomes From Baseline to 8 Weeks Cognitive	5.8 score on a scale Standard Deviation 9.6	0.25 score on a scale Standard Deviation 11.8
Change in Child Developmental Outcomes From Baseline to 8 Weeks Expressive Communication	3.9 score on a scale Standard Deviation 2.9	2.8 score on a scale Standard Deviation 6.5
Change in Child Developmental Outcomes From Baseline to 8 Weeks Receptive Communication	3.9 score on a scale Standard Deviation 4.1	2 score on a scale Standard Deviation 4.5
Change in Child Developmental Outcomes From Baseline to 8 Weeks Gross Motor	6.3 score on a scale Standard Deviation 8.6	1.6 score on a scale Standard Deviation 3.1
Change in Child Developmental Outcomes From Baseline to 8 Weeks Fine Motor	4.2 score on a scale Standard Deviation 6.4	2.2 score on a scale Standard Deviation 5.8

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Explorer Mini First (AB Arm) n=12 Participants 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. Permobil Explorer Mini: 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 Car: 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.	Modified Ride On Car First (BA Arm) n=12 Participants 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. Permobil Explorer Mini: 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 Car: 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.
Change in Child Developmental Outcomes From 8 Weeks to 16 Weeks Cognitive	1.1 score on a scale Standard Deviation 8.3	7.4 score on a scale Standard Deviation 11.8
Change in Child Developmental Outcomes From 8 Weeks to 16 Weeks Expressive Communication	-0.1 score on a scale Standard Deviation 2.9	-0.5 score on a scale Standard Deviation 4.0
Change in Child Developmental Outcomes From 8 Weeks to 16 Weeks Receptive Communication	0.4 score on a scale Standard Deviation 3.6	0.9 score on a scale Standard Deviation 4.4
Change in Child Developmental Outcomes From 8 Weeks to 16 Weeks Gross Motor	1.1 score on a scale Standard Deviation 3.2	0.2 score on a scale Standard Deviation 6.9
Change in Child Developmental Outcomes From 8 Weeks to 16 Weeks Fine Motor	1.8 score on a scale Standard Deviation 5.5	0.4 score on a scale Standard Deviation 5.7

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Explorer Mini First (AB Arm) n=12 Participants 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. Permobil Explorer Mini: 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 Car: 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.	Modified Ride On Car First (BA Arm) n=12 Participants 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. Permobil Explorer Mini: 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 Car: 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.
Change in Child Developmental Outcomes From Baseline to 16 Weeks Cognitive Subscale	6.8 score on a scale Standard Deviation 7.4	7.7 score on a scale Standard Deviation 13.3
Change in Child Developmental Outcomes From Baseline to 16 Weeks Expressive Communication Subscale	3.8 score on a scale Standard Deviation 3.6	2.3 score on a scale Standard Deviation 6.2
Change in Child Developmental Outcomes From Baseline to 16 Weeks Receptive Communication Subscale	4.3 score on a scale Standard Deviation 5.3	2.9 score on a scale Standard Deviation 6.1
Change in Child Developmental Outcomes From Baseline to 16 Weeks Gross Motor Subscale	7.3 score on a scale Standard Deviation 7.9	1.8 score on a scale Standard Deviation 6.9
Change in Child Developmental Outcomes From Baseline to 16 Weeks Fine Motor Subscale	5.9 score on a scale Standard Deviation 6.2	2.6 score on a scale Standard Deviation 5.2

PRIMARY outcome

Timeframe: At baseline, after first 8-week device intervention period.

Population: In this parent reported measure, all 12 participants in each arm fully completed all items in section 1 (Frequency of Participation) and section 3 (Participation in Self Care). However, 3 participants in the AB Arm and 4 participants in the BA arm chose to leave portions of section 2 (Enjoyment of Participation) blank. Therefore, there were many items in this section that had no comparator values. Thus, we included all participants who had fully completed all items for analysis from section 2.

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.

Outcome measures

Outcome measures
Measure	Explorer Mini First (AB Arm) n=12 Participants 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. Permobil Explorer Mini: 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 Car: 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.	Modified Ride On Car First (BA Arm) n=12 Participants 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. Permobil Explorer Mini: 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 Car: 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.
Change in Child Participation and Recreational Activities From Baseline to 8 Weeks Frequency of Participation	3.8 score on a scale Standard Deviation 12.1	-0.9 score on a scale Standard Deviation 9.2
Change in Child Participation and Recreational Activities From Baseline to 8 Weeks Enjoyment of Participation	-0.1 score on a scale Standard Deviation 5.3	2 score on a scale Standard Deviation 6.4
Change in Child Participation and Recreational Activities From Baseline to 8 Weeks Participation in Self Care	7.3 score on a scale Standard Deviation 10.2	0.3 score on a scale Standard Deviation 5.7

PRIMARY outcome

Timeframe: After second 8-week device intervention period.

Population: In this parent reported measure, all 12 participants in each arm fully completed all items in section 1 (Frequency of Participation) and section 3 (Participation in Self Care). However, 3 participants in the AB Arm and 4 participants in the BA arm chose to leave portions of section 2 (Enjoyment of Participation) blank. Therefore, there were many items in this section that had no comparator values. Thus, we included all participants who had fully completed all items for analysis from section 2.

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.

Outcome measures

Outcome measures
Measure	Explorer Mini First (AB Arm) n=12 Participants 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. Permobil Explorer Mini: 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 Car: 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.	Modified Ride On Car First (BA Arm) n=12 Participants 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. Permobil Explorer Mini: 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 Car: 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.
Change in Child Participation and Self-care Activities From 8 Weeks to 16 Weeks Frequency of Participation	0.2 score on a scale Standard Deviation 11.0	2.9 score on a scale Standard Deviation 8.1
Change in Child Participation and Self-care Activities From 8 Weeks to 16 Weeks Enjoyment of Participation	0.4 score on a scale Standard Deviation 5.3	-1.1 score on a scale Standard Deviation 5.2
Change in Child Participation and Self-care Activities From 8 Weeks to 16 Weeks Participation in Self Care Activities	2.8 score on a scale Standard Deviation 8.2	0.3 score on a scale Standard Deviation 6.7

PRIMARY outcome

Timeframe: At baseline, and after the second 8-week device period.

Population: In this parent reported measure, all 12 participants in each arm fully completed all items in section 1 (Frequency of Participation) and section 3 (Participation in Self Care). However, 3 participants in the AB Arm and 4 participants in the BA arm chose to leave portions of section 2 (Enjoyment of Participation) blank. Therefore, there were many items in this section that had no comparator values. Thus, we included all participants who had fully completed all items for analysis from section 2.

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.

Outcome measures

Outcome measures
Measure	Explorer Mini First (AB Arm) n=12 Participants 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. Permobil Explorer Mini: 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 Car: 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.	Modified Ride On Car First (BA Arm) n=12 Participants 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. Permobil Explorer Mini: 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 Car: 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.
Change in Child Participation and Self Care Outcomes From Baseline to 16 Weeks Enjoyment of Participation	0.3 score on a scale Standard Deviation 3.6	0.9 score on a scale Standard Deviation 3.4
Change in Child Participation and Self Care Outcomes From Baseline to 16 Weeks Participation in Self Care	10.1 score on a scale Standard Deviation 12.6	0.6 score on a scale Standard Deviation 5.6
Change in Child Participation and Self Care Outcomes From Baseline to 16 Weeks Frequency of Participation	4 score on a scale Standard Deviation 4.3	2 score on a scale Standard Deviation 4.2

SECONDARY outcome

Timeframe: After first 8-week device intervention period.

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.

Outcome measures

Outcome measures
Measure	Explorer Mini First (AB Arm) n=12 Participants 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. Permobil Explorer Mini: 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 Car: 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.	Modified Ride On Car First (BA Arm) n=12 Participants 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. Permobil Explorer Mini: 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 Car: 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.
Acceptability, Intervention Appropriateness, and Feasibility of The Explorer Mini Acceptability of the Explorer Mini	4.5 score on a scale Standard Deviation 0.7	4.3 score on a scale Standard Deviation 1.0
Acceptability, Intervention Appropriateness, and Feasibility of The Explorer Mini Intervention Appropriateness of the Explorer Mini	3.8 score on a scale Standard Deviation 1.2	4 score on a scale Standard Deviation 1.3
Acceptability, Intervention Appropriateness, and Feasibility of The Explorer Mini Feasibility of Adoption of the Explorer Mini	4.1 score on a scale Standard Deviation 0.9	4.1 score on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: After second 8-week device intervention period.

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.

Outcome measures

Outcome measures
Measure	Explorer Mini First (AB Arm) n=12 Participants 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. Permobil Explorer Mini: 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 Car: 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.	Modified Ride On Car First (BA Arm) n=12 Participants 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. Permobil Explorer Mini: 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 Car: 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.
Acceptability, Intervention Appropriateness, and Feasibility of the Ride-On Car Acceptability of the Ride On Car	3.4 score on a scale Standard Deviation 1.4	4.5 score on a scale Standard Deviation 0.9
Acceptability, Intervention Appropriateness, and Feasibility of the Ride-On Car Intervention Appropriateness of the Ride on Car	3.0 score on a scale Standard Deviation 1.4	4.6 score on a scale Standard Deviation 0.7
Acceptability, Intervention Appropriateness, and Feasibility of the Ride-On Car Feasibility of Adoption of the Ride on Car	3.5 score on a scale Standard Deviation 1.2	4.1 score on a scale Standard Deviation 1.1

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Heather Feldner, Study PI

University of Washington Department of Rehabilitation Medicine

Phone: 2065433721

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place