Early Powered Mobility for Toddlers With Cerebral Palsy Using the Permobil® Explorer Mini and a Modified Ride-On Car
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

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.
    

Intervention name(s): Permobil Explorer Mini; Modified Ride-On Car
Intervention type(s): Device; Device
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Crossover Assignment
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.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: At risk for cerebral palsy