An interventional study of VRSim 3.0 and In-Person Wheelchair Training in Spinal Diseases, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2022-08-09.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Other
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.
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.
267 studies on the registry are indexed under Spinal Diseases; 54 are open to participants now.
This study's enrollment of 12 is below the median of 52 across 166 interventional studies indexed under Spinal Diseases.
Browse Spinal Diseases studies →University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive virtual reality power wheelchair training using VRSim 3.0 in this group.
Other: VRSim 3.0
Participants will receive in-person wheelchair training by a therapist in this group.
Behavioral: In-Person Wheelchair Training
VRSim 3.0 is a virtual reality training module.
A therapist will be used to train power wheelchair users.
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.
Time frame: This outcome measure will be assessed at each of 4 training sessions, which may take up to one year to complete.
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).
Time frame: This outcome measure will be assessed at the completion of the study, which may take up to one year to complete.
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.
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.
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.
Time frame: This outcome measure will be assessed at each of 4 training sessions, which may take up to one year to complete.
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.
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.
Plan to share: No
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This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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