An interventional study of IndieTrainer system in Cerebral Palsy and Conditions Similar to Cerebral Palsy, sponsored by Grand Valley State University. Completed at 1 site in United States. Open to participants aged 3 Years to 21 Years. Per ClinicalTrials.gov, last updated 2025-07-31.
Sponsored by Grand Valley State University · Not applicable, Interventional, and Treatment
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.
1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.
This study's enrollment of 25 is below the median of 34 across 1,431 interventional studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →Grand Valley State University is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
The child and his/her manual wheelchair or adaptive stroller combined must weigh \<300 pounds to safely use the IndieTrainer.
All child participants receive power wheelchair skills training using the IndieTrainer system.
Other: 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.
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
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.
Time frame: 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
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.
Time frame: 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.
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.
Time frame: 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
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.
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
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.
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.
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
Parent/Caregiver Satisfaction With the IndieTrainer System Intervention 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.
Time frame: Immediately after the conclusion of the intervention at Week 3
Although child-parent/caregiver dyads were enrolled in this study, only child participants received the intervention.
| Milestone | Single Arm: All Child Participants Receive the Intervention |
|---|---|
| Started | 25 |
| Completed | 25 |
| Not completed | 0 |
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.
| score on a scale | Single Arm: All Child Participants Receive the Intervention |
|---|---|
| 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 | 2.68 ± 0.8524 |
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.
| score on a scale | Single Arm: All Child Participants Receive the Intervention |
|---|---|
| Change in Child Participants' Power Mobility Skill Performance Between Baseline and Immediately After the Conclusion of the Intervention Period at Week 3 | 1.1486 ± 0.3535 |
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.
| score on a scale | Single Arm: All Child Participants Receive the Intervention |
|---|---|
| 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. | 6.864 ± 1.4739 |
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.
| score on a scale | Single Arm: All Child Participants Receive the Intervention |
|---|---|
| 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 | 0.16 ± 0.3742 |
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.
| score on a scale | Single Arm: All Child Participants Receive the Intervention |
|---|---|
| Parent/Caregiver Satisfaction With the IndieTrainer System Intervention Immediately After the Conclusion of the Intervention at Week 3 | 31.52 ± .77 |
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.
| score on a scale | Single Arm: All Child Participants Receive the Intervention |
|---|---|
| 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. | 0.0514 ± 0.0911 |
Collected over 7 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single Arm: All Participants Receive the Intervention | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
Baseline data were not collected for parents/caregivers.
| Age, Continuous(Months) | Single Arm: All Child Participants Receive the Intervention |
|---|---|
| Mean | 109 ± 47 |
| Sex: Female, Male(Participants) | Single Arm: All Child Participants Receive the Intervention |
|---|---|
| Female | 15 |
| Male | 10 |
| Ethnicity (NIH/OMB)(Participants) | Single Arm: All Child Participants Receive the Intervention |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 23 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Single Arm: All Child Participants Receive the Intervention |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 4 |
| White | 20 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Single Arm: All Child Participants Receive the Intervention |
|---|---|
| United States | 25 |
| Assessment of Learning Powered Mobility Use(units on a scale) | Single Arm: All Child Participants Receive the Intervention |
|---|---|
| Mean | 2.24 ± .78 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — 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.
Supporting information: Study protocol, Informed consent form, Clinical study report
Time frame: IPD will be made available 6 months following publication of study results
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.
Ran from Sep 2022 to primary completion in Oct 2023, 13 months.
Results were first posted in Jul 2025, 1 year 9 months after primary completion.
Of 902 non-industry interventional studies with no phase under Cerebral Palsy, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's 13 months is close to that.
Counting every sponsor, half of 921 studies reached it within 12 months; a quarter within 5 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Grand Valley State University