Virtual Reality for Power Wheelchair Training

Sponsor
University of Pittsburgh (Other)
Overall Status
Completed
CT.gov ID
NCT03562455
Collaborator
(none)
12
1
2
13.4
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: VRSim 3.0
  • Behavioral: In-Person Wheelchair Training
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
12 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.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 :
Jun 19, 2018
Actual Primary Completion Date :
Aug 2, 2019
Actual Study Completion Date :
Aug 2, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Power Wheelchair Driving Skill [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Human Engineering Research Laboratories Pittsburgh Pennsylvania United States 15206

Sponsors and Collaborators

  • University of Pittsburgh

Investigators

  • Principal Investigator: Brad E Dicianno, MD, University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Brad Dicianno, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT03562455
Other Study ID Numbers:
  • PRO18010297
First Posted:
Jun 19, 2018
Last Update Posted:
Aug 9, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Brad Dicianno, Associate Professor, University of Pittsburgh
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 9, 2022