IndieTrainer: Enabling Individuals With Cerebral Palsy to Receive Power Mobility Training

Not Applicable

Completed

Conditions: Cerebral Palsy
Conditions Similar to Cerebral Palsy

Registration Number: NCT05473182

Lead Sponsor: Grand Valley State University

Brief Summary: Power wheelchairs 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 power wheelchairs skills needed to "qualify" for their own power wheelchairs. 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 television 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 3-21 years.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 25

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Child Participants' Understanding How to Use a Power Mobility Device Between Baseline and Immediately After the Conclusion of the Intervention Period at Week 3	From baseline to immediately after the conclusion of the intervention period at Week 3	This outcome will be assessed using each child participant's score (from a minimum of 1 to a maximal of 8) on the Assessment of Learning Powered mobility use. The Assessment of Learning Powered mobility use measures a child's understanding of how to use a power mobility device. Higher scores indicate a better outcome.
Change in Child Participants' Power Mobility Skill Performance Between Baseline and Immediately After the Conclusion of the Intervention Period at Week 3	From baseline to immediately after the conclusion of the intervention period at Week 3	This outcome will be assessed using the Wheelchair Skills Checklist that evaluates a child's performance of 7 items, each reflecting a specific power mobility skill. Each item is scored from a minimum of 0 to a maximum of 2 with a higher score indicating a better outcome. Total scores for all 7 items range from a minimum of 0 to a maximum of 14 with higher scores therefore indicate a better outcome.
Change in Parental/Caregiver Perceptions of Their Child's Power Mobility Skills Performance Between Baseline and Immediately Following the End of the Intervention Period at Week 3.	From baseline to immediately after the conclusion of the intervention period at Week 3	This outcome will be assessed using the Canadian Occupational Performance Measure to rate parent/caregiver perceptions of their child's performance of 5 power mobility skills. Each skill is rated from a minimum of 1 to a maximum of 10. A higher score indicates a better outcome. The total score on all 5 items ranges from a minimum of 5 to a maximum of 50. A higher score indicates a better outcome.
Change in Child Participants' Understanding How to Use a Power Mobility Device From Immediately After the Conclusion of the Intervention Period at Week 3 to the End of the Follow-up Period at Week 7	From immediately after the conclusion of the intervention period at Week 3 to the end of the follow-up period at Week 7	This outcome will be assessed using each child participant's score (from a minimum of 1 to a maximal of 8) on the Assessment of Learning Powered mobility use. The Assessment of Learning Powered mobility use measures a child's understanding of how to use a power mobility device. Higher scores indicate a better outcome.
Change in Child Participants' Power Mobility Skill Performance Between the Conclusion of the Intervention Period at Week 3 and the End of the Follow up Period at Week 7.	From immediately after the conclusion of the intervention period at Week 3 to the end of the follow-up period at Week 7	This outcome will be assessed using the Wheelchair Skills Checklist that evaluates a child's performance of 7 items, each reflecting a specific power mobility skill. Each item is scored from a minimum of 0 to a maximum of 2 with a higher score indicating a better outcome. Total scores for all 7 items range from a minimum of 0 to a maximum of 14 with higher scores therefore indicate a better outcome.

Secondary Outcome Measures

Name	Time	Method
Parent/Caregiver Satisfaction With the IndieTrainer System Intervention Immediately After the Conclusion of the Intervention at Week 3	Immediately after the conclusion of the intervention at Week 3	This outcome will be assessed through use of the Client Satisfaction Questionnaire-8 an 8-item questionnaire exploring stakeholder satisfaction with an intervention. Response choices for each item range from minimum of 1 to a maximum of 4. Higher scores indicate higher satisfaction. Total scores on the Client Satisfaction Questionnaire-8 range from a minimum of 8 to a maximum of 32. Higher total scores indicate higher satisfaction with the intervention.

Trial Locations

Locations (1): Grand Valley State University
🇺🇸
Grand Rapids, Michigan, United States
Grand Valley State University
🇺🇸Grand Rapids, Michigan, United States