IndieTrainer: Enabling Individuals With Cerebral Palsy to Receive Gamified Power Mobility Training in Their Own Manual Wheelchairs
Primary Purpose
Cerebral Palsy, Conditions Similar to Cerebral Palsy
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IndieTrainer system
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy
Eligibility Criteria
Inclusion Criteria:
- Has a diagnosis of cerebral palsy with functional abilities at Gross Motor Classification System Classification System Levels 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.
Sites / Locations
- Grand Valley State UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single arm: All participants receive the intervention
Arm Description
All participants receive power wheelchair skills training using the IndieTrainer system.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
Parent/caregiver satisfaction with the IndieTrainer system
This outcome will be assessed at post-intervention through use of the Client Satisfaction Questionnaire-8
Full Information
NCT ID
NCT05473182
First Posted
July 21, 2022
Last Updated
February 18, 2023
Sponsor
Grand Valley State University
1. Study Identification
Unique Protocol Identification Number
NCT05473182
Brief Title
IndieTrainer: Enabling Individuals With Cerebral Palsy to Receive Gamified Power Mobility Training in Their Own Manual Wheelchairs
Official Title
IndieTrainer: Enabling Individuals With Cerebral Palsy to Receive Gamified Power Mobility Training in Their Own Manual Wheelchairs
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2022 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Grand Valley State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Conditions Similar to Cerebral Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
One group pretest-posttest design with a single session retention trial 4 weeks after the end of the intervention period.
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single arm: All participants receive the intervention
Arm Type
Other
Arm Description
All participants receive power wheelchair skills training using the IndieTrainer system.
Intervention Type
Other
Intervention Name(s)
IndieTrainer system
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in understanding how to use a power mobility device
Description
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.
Time Frame
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
Title
Change in power mobility skill performance
Description
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.
Time Frame
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
Title
Change in power mobility skills performance
Description
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.
Time Frame
Baseline-pre-intervention and immediately after the conclusion of the intervention period,
Secondary Outcome Measure Information:
Title
Changes in perceptions regarding the IndieTrainer system intervention
Description
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.
Time Frame
Baseline -pre-intervention and immediately after the conclusion of the intervention
Title
Parent/caregiver satisfaction with the IndieTrainer system
Description
This outcome will be assessed at post-intervention through use of the Client Satisfaction Questionnaire-8
Time Frame
Immediately after the conclusion of the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa K. Kenyon, PT, PhD, PCS
Phone
616-331-5653
Email
kenyonli@gvsu.edu
Facility Information:
Facility Name
Grand Valley State University
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49504
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa K. Kenyon, PT, DPT, PhD, PCS
Phone
616-331-5653
Email
kenyonli@gvsu.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
IndieTrainer: Enabling Individuals With Cerebral Palsy to Receive Gamified Power Mobility Training in Their Own Manual Wheelchairs
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