NCT03562455

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 19, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

June 19, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2019

Completed
Last Updated

August 9, 2022

Status Verified

August 1, 2022

Enrollment Period

1.1 years

First QC Date

May 22, 2018

Last Update Submit

August 8, 2022

Conditions

Keywords

Virtual RealityWheelchairs

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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.

  • 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.

  • 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.

  • 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.

Study Arms (2)

Virtual Reality Training

EXPERIMENTAL

Participants will receive virtual reality power wheelchair training using VRSim 3.0 in this group.

Other: VRSim 3.0

In-person Therapist Training

ACTIVE COMPARATOR

Participants will receive in-person wheelchair training by a therapist in this group.

Behavioral: In-Person Wheelchair Training

Interventions

VRSim 3.0 is a virtual reality training module.

Virtual Reality Training

A therapist will be used to train power wheelchair users.

In-person Therapist Training

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Engineering Research Laboratories

Pittsburgh, Pennsylvania, 15206, United States

Location

MeSH Terms

Conditions

Spinal Diseases

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Study Officials

  • Brad E Dicianno, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The individual assessing performance outcomes will not be aware of which intervention the participants received.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 22, 2018

First Posted

June 19, 2018

Study Start

June 19, 2018

Primary Completion

August 2, 2019

Study Completion

August 2, 2019

Last Updated

August 9, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations