Virtual Reality for Power Wheelchair Training
Primary Purpose
Spinal Diseases
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VRSim 3.0
In-Person Wheelchair Training
Sponsored by
About this trial
This is an interventional other trial for Spinal Diseases focused on measuring Virtual Reality, Wheelchairs
Eligibility Criteria
Inclusion Criteria:
- Volunteers must be 14 years or older.
- Volunteers must have a disability that prevents them from effectively and independently using a manual wheelchair, power assist wheelchair, or scooter.
- Volunteers must be able to communicate in English, follow simple commands, and give written informed consent.
Exclusion Criteria:
- Volunteers with active seizures.
- Volunteers who have active pelvic or thigh wounds.
- Volunteers who require a test wheelchair but who exceed the weight capacity of the test wheelchair (>300 lbs).
- Volunteers who require a test wheelchair but also require specialized seating that cannot be replicated for the training.
Sites / Locations
- Human Engineering Research Laboratories
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Virtual Reality Training
In-person Therapist Training
Arm Description
Participants will receive virtual reality power wheelchair training using VRSim 3.0 in this group.
Participants will receive in-person wheelchair training by a therapist in this group.
Outcomes
Primary Outcome Measures
Power Wheelchair Driving Skill
Power wheelchair driving skills will be evaluated using the Power Mobility Clinical Driving Assessment (PMCDA). The PMCDA contains 23 questions related to specific power wheelchair driving tasks. Each task will be given a score from 1 to 3; a score of 1 will be given if the driver requires physical assistance or cannot complete the task, a score of 2 will be given if the driver requires verbal or auditory hints or cues, but no physical assistance, and a score of 3 will be given if the driver completes the task without help. Scores will be added together for a possible total from 23 to 69.
Secondary Outcome Measures
Perception of Virtual Reality Training System
Qualitative feedback on the participants' experience with VRSim 3.0 will be obtained to inform future software development using a semi-structured interview as well as a Virtual Experience Test (VET) survey. The semi-structured interview will contain open-ended questions aimed at exploring usability factors that may be barriers or facilitators to the use of VR for PWC driving training. The VET is a validated survey instrument that will be used to measure the virtual environment experience. It will contain 17 questions based on based upon five dimensions of experiential design: sensory, cognitive, affective, active, and relational. The survey questions will be scored from 1 (strongly disagree) to 5 (strongly agree).
Simulator Sickness
Participants in the virtual reality group will be given a Simulator Sickness Questionnaire (SSQ) at the beginning and end of each training session to assess the degree of simulator sickness induced by the gaming platform. The SSQ contains 16 questions based on symptoms of simulator sickness, and participants will rate each symptom as either none, slight, moderate, or severe.
Perceived Workload of Training
Participants will be given a NASA-Task Load Index (NASA-TLX) survey to assess perceived workload at the end of each training session. The NASA-TLX contains 6 questions to assess workload on a scale from low to high.
Power Wheelchair Driving Capacity
Participants will be evaluated using the Power Mobility Screening Tool (PMST) to assess driving capacity. The PMST contains 5 questions based on motor, sensory, and cognitive skills. The questions will be scored from 1 to 3, and will be added together for a possible total from 5 to 15.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03562455
Brief Title
Virtual Reality for Power Wheelchair Training
Official Title
Assessing the Effectiveness of Virtual Reality for Power Wheelchair Driving Training
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
June 19, 2018 (Actual)
Primary Completion Date
August 2, 2019 (Actual)
Study Completion Date
August 2, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
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
The objective of this study is to evaluate the impact of VRSim 3.0 on power wheelchair (PWC) driving skills and to obtain qualitative feedback from users on the design of the virtual reality (VR) simulator to inform device development.
Detailed Description
A virtual reality platform may lead to better training of people with complex disabilities who desire to be power wheelchair users and thus allow them to benefit from living a more active life. A virtual reality training program could significantly impact the lives of people with disabilities by improving function, reducing abandonment of power wheelchairs, and reducing morbidity and mortality and associated costs occurring from power wheelchair accidents. This new virtual reality training program will reflect improvements in accessibility, customization, simulator sickness, ease of use, and will have report generating capabilities as compared to previous virtual reality training platforms. The investigators expect that virtual reality training will be a superior alternative to standard in-person wheelchair training.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Diseases
Keywords
Virtual Reality, Wheelchairs
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study will contain two arms. One group will receive virtual reality power wheelchair training, and the other will receive in-person wheelchair training by a therapist.
Masking
Outcomes Assessor
Masking Description
The individual assessing performance outcomes will not be aware of which intervention the participants received.
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Virtual Reality Training
Arm Type
Experimental
Arm Description
Participants will receive virtual reality power wheelchair training using VRSim 3.0 in this group.
Arm Title
In-person Therapist Training
Arm Type
Active Comparator
Arm Description
Participants will receive in-person wheelchair training by a therapist in this group.
Intervention Type
Other
Intervention Name(s)
VRSim 3.0
Intervention Description
VRSim 3.0 is a virtual reality training module.
Intervention Type
Behavioral
Intervention Name(s)
In-Person Wheelchair Training
Intervention Description
A therapist will be used to train power wheelchair users.
Primary Outcome Measure Information:
Title
Power Wheelchair Driving Skill
Description
Power wheelchair driving skills will be evaluated using the Power Mobility Clinical Driving Assessment (PMCDA). The PMCDA contains 23 questions related to specific power wheelchair driving tasks. Each task will be given a score from 1 to 3; a score of 1 will be given if the driver requires physical assistance or cannot complete the task, a score of 2 will be given if the driver requires verbal or auditory hints or cues, but no physical assistance, and a score of 3 will be given if the driver completes the task without help. Scores will be added together for a possible total from 23 to 69.
Time Frame
This outcome measure will be assessed at each of 4 training sessions, which may take up to one year to complete.
Secondary Outcome Measure Information:
Title
Perception of Virtual Reality Training System
Description
Qualitative feedback on the participants' experience with VRSim 3.0 will be obtained to inform future software development using a semi-structured interview as well as a Virtual Experience Test (VET) survey. The semi-structured interview will contain open-ended questions aimed at exploring usability factors that may be barriers or facilitators to the use of VR for PWC driving training. The VET is a validated survey instrument that will be used to measure the virtual environment experience. It will contain 17 questions based on based upon five dimensions of experiential design: sensory, cognitive, affective, active, and relational. The survey questions will be scored from 1 (strongly disagree) to 5 (strongly agree).
Time Frame
This outcome measure will be assessed at the completion of the study, which may take up to one year to complete.
Title
Simulator Sickness
Description
Participants in the virtual reality group will be given a Simulator Sickness Questionnaire (SSQ) at the beginning and end of each training session to assess the degree of simulator sickness induced by the gaming platform. The SSQ contains 16 questions based on symptoms of simulator sickness, and participants will rate each symptom as either none, slight, moderate, or severe.
Time Frame
This outcome measure will be assessed at the beginning and end of 4 training sessions, which may take up to one year to complete.
Title
Perceived Workload of Training
Description
Participants will be given a NASA-Task Load Index (NASA-TLX) survey to assess perceived workload at the end of each training session. The NASA-TLX contains 6 questions to assess workload on a scale from low to high.
Time Frame
This outcome measure will be assessed at each of 4 training sessions, which may take up to one year to complete.
Title
Power Wheelchair Driving Capacity
Description
Participants will be evaluated using the Power Mobility Screening Tool (PMST) to assess driving capacity. The PMST contains 5 questions based on motor, sensory, and cognitive skills. The questions will be scored from 1 to 3, and will be added together for a possible total from 5 to 15.
Time Frame
This outcome measure will be measured at the beginning and end of the study, which may take up to one year to complete.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Volunteers must be 14 years or older.
Volunteers must have a disability that prevents them from effectively and independently using a manual wheelchair, power assist wheelchair, or scooter.
Volunteers must be able to communicate in English, follow simple commands, and give written informed consent.
Exclusion Criteria:
Volunteers with active seizures.
Volunteers who have active pelvic or thigh wounds.
Volunteers who require a test wheelchair but who exceed the weight capacity of the test wheelchair (>300 lbs).
Volunteers who require a test wheelchair but also require specialized seating that cannot be replicated for the training.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brad E Dicianno, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Human Engineering Research Laboratories
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Virtual Reality for Power Wheelchair Training
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