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

NCT05473182 | Completed Results

• 1 other identifier: 20-278-H
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy; Conditions Similar to Cerebral Palsy

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  From immediately after the conclusion of the intervention period at Week 3 to the end of the follow-up period at Week 7

Secondary Outcomes (1)

• 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

Study Arms (1)

Single arm: All child participants receive the intervention

OTHER

All child participants receive power wheelchair skills training using the IndieTrainer system.

Other: IndieTrainer system

Interventions

IndieTrainer system OTHER

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.

Single arm: All child participants receive the intervention

Eligibility Criteria

• Age: 3 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Grand Valley State University: lead

Study Sites (1)

Grand Valley State University

Grand Rapids, Michigan, 49504, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Dr. Lisa K. Kenyon
• Organization: Grand Valley State Univeristy College of Health Professions

kenyonli@gvsu.edu

616-331-5653

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: One group pretest-posttest design with a single session retention trial 4 weeks after the end of the intervention period.

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: July 25, 2022
• Study Start: September 8, 2022
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: July 31, 2025
• Results First Posted: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• 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.

Locations

US (1)