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

Cerebral Palsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04684576
• Other study ID #: STUDY00011386
• Secondary ID: P2CHD101912
• Status: Completed
• Phase: N/A
• Start date: April 15, 2021
• Est. completion date: May 20, 2022

Study information

• Verified date: August 2023
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 20, 2022
• Est. primary completion date: May 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 36 Months

Eligibility

Inclusion Criteria:

The child will:

1. be between 12-36 months old;

2. 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;

3. be able to attain a seated position with or without support;

4. be able to tolerate upright sitting with or without support while moving through space for 30 minutes;

5. live in a household where English is spoken proficiently.

Adults will:

1. be 18 years or older and be the legal caregiver for the child participant;

2. demonstrate proficiency in English. Inclusion criteria will be secured via caregiver report using screening questions.

Exclusion Criteria:

Child will be excluded if:

1. 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);

2. if they cannot attain a seated position with or without support;

3. if they cannot tolerate upright sitting with or without support for 30 minutes;

Adult caregivers will be excluded if:

4. they are not proficient in English (determined per screening process).

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Oregon State University	Corvallis	Oregon
United States	Grand Valley State University	Grand Rapids	Michigan
United States	University of Washington	Seattle	Washington

Sponsors (4)

Lead Sponsor	Collaborator
University of Washington	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Grand Valley State University, Oregon State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in Caregiver Perceptions of Powered Mobility Devices, Facilitators and Barriers to Use, and Perceptions of Their Child's Developmental Progress Between 8 Weeks and 16 Weeks.	Semi-structured interviews with caregivers using an interview guide will be conducted to understand their experiences using the respective powered mobility devices, barriers encountered and solutions discovered, and perceptions of self-efficacy and behavioral capacity.	After second 8-week device intervention period.
Other	Changes in Caregiver Perceptions of Powered Mobility Devices, Facilitators and Barriers to Use, and Perceptions of Their Child's Developmental Progress Between Baseline and 8 Weeks.	Semi-structured interviews with caregivers using an interview guide will be conducted to understand their experiences using the respective powered mobility devices, barriers encountered and solutions discovered, and perceptions of self-efficacy and behavioral capacity.	At baseline, after first 8-week device intervention period.
Other	Change in Child Participation and Environmental Supportiveness From 8 Weeks to 16 Weeks.	Young Children's Participation & Environment Measure (YC-PEM).The YC-PEM is a caregiver survey tool that has 3 sections: home, daycare/preschool, and community, with each section assessing participation and the environment. For participation items, parents are asked how often their child has participated in different types of activities, how involved their child is when participating in activities of this type, and if parents would like their child's participation to change. For environment items, parents are asked if specific aspects of the environment facilitate or hinder their child's participation and if specific supports are available and/or adequate to support their child's participation.	After second 8-week device intervention period.
Other	Device Use Frequency and Patterns	Caregivers will complete a driving log that indicates the date, time, and environment of Explorer Mini (A) or modified ride-on car use (B). Caregivers will also make notes about the child's enjoyment level and general activities while using each device. To supplement caregiver reported data, automated device use data such as frequency and duration of activation, average speed, and distance traveled, will be collected either via a custom data logger (mounted on the modified ride-on car) or through integrated device systems (built-in to the Explorer Mini).	Through study completion at 16 weeks.
Other	Change in Child Participation and Environmental Supportiveness From Baseline to 8 Weeks.	Young Children's Participation & Environment Measure (YC-PEM).The YC-PEM is a caregiver survey tool that has 3 sections: home, daycare/preschool, and community, with each section assessing participation and the environment. For participation items, parents are asked how often their child has participated in different types of activities, how involved their child is when participating in activities of this type, and if parents would like their child's participation to change. For environment items, parents are asked if specific aspects of the environment facilitate or hinder their child's participation and if specific supports are available and/or adequate to support their child's participation.	At baseline, after first 8-week device intervention period.
Primary	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
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.