Virtual Reality for Power Wheelchair Training

Assessing the Effectiveness of Virtual Reality for Power Wheelchair Driving Training

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.

Study Overview

• Status: Completed
• Conditions: Spinal Diseases
• Intervention / Treatment: Other: VRSim 3.0; Behavioral: In-Person Wheelchair Training

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15206
      • Human Engineering Research Laboratories

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	This outcome measure will be assessed at each of 4 training sessions, which may take up to one year to complete.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	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.	This outcome measure will be measured at the beginning and end of the study, which may take up to one year to complete.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2018
• Primary Completion (Actual): August 2, 2019
• Study Completion (Actual): August 2, 2019

Study Registration Dates

• First Submitted: May 22, 2018
• First Submitted That Met QC Criteria: June 7, 2018
• First Posted (Actual): June 19, 2018

Study Record Updates

• Last Update Posted (Actual): August 9, 2022
• Last Update Submitted That Met QC Criteria: August 8, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Virtual Reality; Wheelchairs
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Spinal Diseases
• Other Study ID Numbers: PRO18010297

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No