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

NCT ID: NCT04684576

Last Updated: 2023-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-15
• Study Completion Date: 2022-05-20

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.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Permobil Explorer Mini

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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.

Group Type: ACTIVE_COMPARATOR

Permobil Explorer Mini

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

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;

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).

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 36 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oregon State University

OTHER

Sponsor Role: collaborator

Grand Valley State University

OTHER

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Heather Feldner

Assistant Professor, School of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heather A Feldner, PT, PhD, PCS

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Grand Valley State University

Grand Rapids, Michigan, United States

Oregon State University

Corvallis, Oregon, United States

University of Washington

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

P2CHD101912

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00011386

Identifier Type: -

Identifier Source: org_study_id