- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05473182
IndieTrainer: Enabling Individuals With Cerebral Palsy to Receive Power Mobility Training
July 30, 2025 updated by: Lisa Kenyon, Grand Valley State University
IndieTrainer: Enabling Individuals With Cerebral Palsy to Receive Gamified Power Mobility Training in Their Own Manual Wheelchairs
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Grand Rapids, Michigan, United States, 49504
- Grand Valley State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 21 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Single arm: All child participants receive the intervention
All child participants receive power wheelchair skills training using the IndieTrainer system.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
Time Frame: 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.
|
From baseline to immediately after the conclusion of the intervention period at Week 3
|
|
Change in Child Participants' Power Mobility Skill Performance Between Baseline and Immediately After the Conclusion of the Intervention Period at Week 3
Time Frame: 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.
|
From baseline to immediately after the conclusion of the intervention period at Week 3
|
|
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.
Time Frame: 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.
|
From baseline to immediately after the conclusion of the intervention period at Week 3
|
|
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
Time Frame: 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.
|
From immediately after the conclusion of the intervention period at Week 3 to the end of the follow-up period at Week 7
|
|
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.
Time Frame: 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.
|
From immediately after the conclusion of the intervention period at Week 3 to the end of the follow-up period at Week 7
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parent/Caregiver Satisfaction With the IndieTrainer System Intervention Immediately After the Conclusion of the Intervention at Week 3
Time Frame: 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.
|
Immediately after the conclusion of the intervention at Week 3
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 8, 2022
Primary Completion (Actual)
October 31, 2023
Study Completion (Actual)
October 31, 2023
Study Registration Dates
First Submitted
July 21, 2022
First Submitted That Met QC Criteria
July 21, 2022
First Posted (Actual)
July 25, 2022
Study Record Updates
Last Update Posted (Actual)
July 31, 2025
Last Update Submitted That Met QC Criteria
July 30, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-278-H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Consist with NIH requirements, at the conclusion of the study, deidentified data collected in this study will be placed in a repository where it can be accessed by other researchers for future studies.
IPD Sharing Time Frame
IPD will be made available 6 months following publication of study results
IPD Sharing Access Criteria
Study results and summaries will be publicly available at clinicaltrials.gov.
For specific IPD, the study PI and co-investigators will review all requests for data sharing.
Data will be shared for purposes of secondary analysis, contribution to a population-related database, or similar reasons that are intended to advance the evidence-based provision of family-centered care for children with disabilities.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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