IndieTrainer: Enabling Individuals With Cerebral Palsy to Receive Gamified Power Mobility Training in Their Own Manual Wheelchairs

Cerebral Palsy Clinical Trial

Official title:

IndieTrainer: Enabling Individuals With Cerebral Palsy to Receive Gamified Power Mobility Training in Their Own Manual Wheelchairs

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05473182
• Other study ID #: 20-278-H
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 15, 2022
• Est. completion date: September 1, 2024

Study information

• Verified date: February 2024
• Source: Grand Valley State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: September 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

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.

Locations

Country	Name	City	State
United States	Grand Valley State University	Grand Rapids	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Grand Valley State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in understanding how to use a power mobility device	This outcome will be assessed using each participant's score (from a low of Phase 1 to a high of Phase 8) on the Assessment of Learning Powered mobility use. The Assessment of Learning Powered mobility use (ALP) is a process-based measure detailing 8 phases of learning (Phase 1 - Novice to Phase 8 - Expert) within 3 stages: Stage 1 - the Introvert Stage where the child focuses on exploring cause and effect within the function of the power mobility device; Stage 2 - the Explore Sequencing Stage where the child focuses on how to sequence the operations to maneuver the power mobility device; and Stage 3 - the Extrovert Stage where the child is focused on using the power mobility device in daily life. Higher scores therefore indicate a better outcome.	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
Primary	Change in power mobility skill performance	This outcome will be assessed using the Wheelchair Skills Checklist, a task-based measure that evaluates a child's performance of 7 specific power mobility skills using a 3-point ordinal scale from 0-2 where a score of "0" indicates the participant Does Not Perform the skill, a score of "1" indicates that the skill is Emerging, and a score of "2" indicates the participant Performs the Skill. Higher scores therefore indicate a better outcome.	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
Primary	Change in power mobility skills performance	This outcome will be assessed using the Canadian Occupational Performance Measure to identify, prioritize, and rate parent/caregiver perceptions of children's performance of power mobility skills. A total of 4-5 occupational performance issues in the area of power mobility skills will be identified and scored on a 1-10 scale, where a "1" is the lowest score and a "10 is the highest score, for both the caregiver's perception of the child's performance and their satisfaction with the child's performance.	Baseline-pre-intervention and immediately after the conclusion of the intervention period,
Secondary	Changes in perceptions regarding the IndieTrainer system intervention	Parental/caregivers' perceptions of the IndieTrainer system intervention will be gathered via a recorded qualitative interview. An interview guide has been developed for this purpose.	Baseline -pre-intervention and immediately after the conclusion of the intervention
Secondary	Parent/caregiver satisfaction with the IndieTrainer system	This outcome will be assessed at post-intervention through use of the Client Satisfaction Questionnaire-8	Immediately after the conclusion of the intervention