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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Early Powered Mobility for Toddlers With Cerebral Palsy: A Comparative Case Series of the Permobil® Explorer Mini and a Modified Ride-On Car

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Device: Permobil Explorer Mini
* Device: Modified Ride-On Car


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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. Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 36 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Explorer Mini First (AB Arm)<br>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. | Device: Permobil Explorer Mini<br>* 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.<br>Device: Modified Ride-On Car<br>* 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.<br>|
| Active Comparator: Modified Ride On Car First (BA Arm)<br>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. | Device: Permobil Explorer Mini<br>* 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.<br>Device: Modified Ride-On Car<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | At baseline, and after the second 8-week device period. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | After second 8-week device intervention period. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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At risk for cerebral palsy