Clinical trial NCT04684576: Early Powered Mobility for Toddlers With Cerebral Palsy Using the Permobil® Explorer Mini and a Modified Ride-On Car
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: At risk for cerebral palsy
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Oregon State University
name: Grand Valley State University
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2020-12-24
Enrollment: 24
Sex: ALL
Minimum age (years): 12
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in Child Developmental Outcomes From Baseline to 8 Weeks
timeFrame: At baseline, after first 8-week device intervention period
measure: Change in Child Developmental Outcomes From 8 Weeks to 16 Weeks
timeFrame: After second 8-week device intervention period.
measure: Change in Child Developmental Outcomes From Baseline to 16 Weeks
timeFrame: At baseline, and after the second 8-week device period.
measure: Change in Child Participation and Recreational Activities From Baseline to 8 Weeks
timeFrame: At baseline, after first 8-week device intervention period.
measure: Change in Child Participation and Self-care Activities From 8 Weeks to 16 Weeks
timeFrame: After second 8-week device intervention period.
measure: Change in Child Participation and Self Care Outcomes From Baseline to 16 Weeks
timeFrame: At baseline, and after the second 8-week device period.
Secondary outcomes:
measure: Acceptability, Intervention Appropriateness, and Feasibility of The Explorer Mini
timeFrame: After first 8-week device intervention period.
measure: Acceptability, Intervention Appropriateness, and Feasibility of the Ride-On Car
timeFrame: After second 8-week device intervention period.
Other outcomes:
measure: 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.
timeFrame: After second 8-week device intervention period.
measure: 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.
timeFrame: At baseline, after first 8-week device intervention period.
measure: Change in Child Participation and Environmental Supportiveness From 8 Weeks to 16 Weeks.
timeFrame: After second 8-week device intervention period.
measure: Device Use Frequency and Patterns
timeFrame: Through study completion at 16 weeks.
measure: Change in Child Participation and Environmental Supportiveness From Baseline to 8 Weeks.
timeFrame: At baseline, after first 8-week device intervention period.
Locations:
city: Grand Rapids
country: United States
facility: Grand Valley State University
state: Michigan
city: Corvallis
country: United States
facility: Oregon State University
state: Oregon
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Heather A Feldner, PT, PhD, PCS
role: PRINCIPAL_INVESTIGATOR
References: