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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 : July 9, 2018
Sponsor:
Information provided by (Responsible Party):
Brad Dicianno, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Spinal Diseases Other: VRSim 3.0 Behavioral: In-Person Wheelchair Training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
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.
Primary Purpose: Other
Official Title: Assessing the Effectiveness of Virtual Reality for Power Wheelchair Driving Training
Actual Study Start Date : June 19, 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Brad E Dicianno, MD 412-822-3700 dicianno@pitt.edu
Contact: Stacy Eckstein, BS 412-822-3700 ste11@pitt.edu

Locations
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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    ste11@pitt.edu   
Sponsors and Collaborators
University of Pittsburgh
Investigators
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Principal Investigator: Brad E Dicianno, MD University of Pittsburgh

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Responsible Party: Brad Dicianno, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03562455     History of Changes
Other Study ID Numbers: PRO18010297
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: July 9, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Brad Dicianno, University of Pittsburgh:
Virtual Reality
Wheelchairs

Additional relevant MeSH terms:
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Spinal Diseases
Bone Diseases
Musculoskeletal Diseases