Virtual Reality for Power Wheelchair Training
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|ClinicalTrials.gov Identifier: NCT03562455|
Recruitment Status : Recruiting
First Posted : June 19, 2018
Last Update Posted : June 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Spinal Diseases||Other: VRSim 3.0 Behavioral: In-Person Wheelchair Training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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:||Single (Outcomes Assessor)|
|Masking Description:||The individual assessing performance outcomes will not be aware of which intervention the participants received.|
|Official Title:||Assessing the Effectiveness of Virtual Reality for Power Wheelchair Driving Training|
|Actual Study Start Date :||June 19, 2018|
|Estimated Primary Completion Date :||September 19, 2019|
|Estimated Study Completion Date :||September 19, 2019|
Experimental: Virtual Reality Training
Participants will receive virtual reality power wheelchair training using VRSim 3.0 in this group.
Other: VRSim 3.0
VRSim 3.0 is a virtual reality training module.
Active Comparator: In-person Therapist Training
Participants will receive in-person wheelchair training by a therapist in this group.
Behavioral: In-Person Wheelchair Training
A therapist will be used to train power wheelchair users.
- Power Wheelchair Driving Skill [ 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 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.
- Perception of Virtual Reality Training System [ Time Frame: This outcome measure will be assessed at the completion of the study, which may take up to one year to complete. ]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 [ 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. ]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 [ Time Frame: This outcome measure will be assessed at each of 4 training sessions, which may take up to one year to complete. ]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 [ 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. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03562455
|Contact: Brad E Dicianno, MDfirstname.lastname@example.org|
|Contact: Stacy Eckstein, BSemail@example.com|
|United States, Pennsylvania|
|Human Engineering Research Laboratories||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15206|
|Contact: Brad E Dicianno, MD|
|Contact: Stacy Eckstein, BS 412-822-3700 firstname.lastname@example.org|
|Principal Investigator:||Brad E Dicianno, MD||University of Pittsburgh|