Clinical trial NCT05473182: IndieTrainer: Enabling Individuals With Cerebral Palsy to Receive Gamified Power Mobility Training in Their Own Manual Wheelchairs
Official title: IndieTrainer: Enabling Individuals With Cerebral Palsy to Receive Gamified Power Mobility Training in Their Own Manual Wheelchairs
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Conditions Similar to Cerebral Palsy
Lead sponsor: Grand Valley State University
Sponsor class: OTHER
First posted: 2022-07-25
Enrollment: 25
Sex: ALL
Minimum age (years): 3
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One group pretest-posttest design with a single session retention trial 4 weeks after the end of the intervention period.
Primary purpose: TREATMENT

Brief summary: Power wheelchairs (PWCs) offer children who are unable to independently opportunities for participation in social, educational, and leisure activities. Unfortunately, children who have severe cognitive, motor, or sensory impairments may need extended training to be able to master the PWC skills needed to "qualify" for their own PWC. The IndieTrainer system was developed to address this need. The IndieTrainer system is comprised of the IndieGo device and video-game modules. The IndieGo device temporarily converts a manual wheelchair into a powered wheelchair, thereby allowing children to remain in their own manual wheelchair and use their own custom seating system during power wheelchair skills training activities. The video-game modules are integrated into the IndieGo device such that the video games can be played on a TV screen using the specific access method used to control the IndieGo (i.e., switch or joystick). The IndieTrainer system is designed to allow a child to practice power wheelchair skills as part of the video-game modules or as part of more traditional power wheelchair skills training activities wherein children are able to actively explore the environment and practice executing actual wheelchair skills. This study will evaluate the use of the IndieTrainer system in children with cerebral palsy, ages 5-21 years.


Eligibility criteria: Inclusion Criteria:

* Has a diagnosis of cerebral palsy or similar conditions with functional abilities consistent with a Gross Motor Classification System Classification System Level IV or Level V
* Inability to functionally self-propel a manual wheelchair
* Does not have an individually prescribed powered wheelchair
* Currently using a manual wheelchair or adaptive stroller that can be safely used with the IndieTrainer system (i.e., functioning wheel brakes to remain locked onto platform, etc.) as assessed by the PI
* Has at least one parent/caregiver who is able to converse in English (as assessed by the PI during interactions over the phone and in person) due to safety concerns

Exclusion Criteria:

* Any condition or issue that would prevent a child from safely using the IndieTrainer system as determined by the PI, a licensed physical therapist.
* The child and his/her manual wheelchair or adaptive stroller combined must weigh \<300 pounds to safely use the IndieTrainer.

  * A diagnosis of a progressive condition with the potential for functional decline across the study period, such as spinal muscular atrophy, Duchenne muscular dystrophy, etc.

Primary outcomes:
measure: Change in understanding how to use a power mobility device
timeFrame: Baseline- pre-intervention, immediately after the conclusion of the intervention period, and at the single session retention trial 4 weeks after the end of the intervention period
measure: Change in power mobility skill performance
timeFrame: Baseline-pre-intervention, immediately after the conclusion of the intervention period, and at the single session retention trial 4 weeks after the end of the intervention period
measure: Change in power mobility skills performance
timeFrame: Baseline-pre-intervention and immediately after the conclusion of the intervention period,
Secondary outcomes:
measure: Changes in perceptions regarding the IndieTrainer system intervention
timeFrame: Baseline -pre-intervention and immediately after the conclusion of the intervention
measure: Parent/caregiver satisfaction with the IndieTrainer system
timeFrame: Immediately after the conclusion of the intervention
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Grand Valley State University
state: Michigan
Study officials:
References: