Spinal DiseasesNCT03562455
Virtual Reality for Power Wheelchair Training
A study testing VRSim 3.0 and In-Person Wheelchair Training in people with Spinal Diseases, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Spinal Diseases
- What is being tested?
- VRSim 3.0 and In-Person Wheelchair Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2018to 2 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Human Engineering Research Laboratories
Pittsburgh, Pennsylvania, 15206
About this study
Official title: 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.
Read the 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.
- Conditions
- Spinal Diseases
- Being tested
- VRSim 3.0, In-Person Wheelchair Training
- Keywords
- Virtual Reality, Wheelchairs
- Medical subject headings
- Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRSim 3.0Other
VRSim 3.0 is a virtual reality training module.
In-Person Wheelchair TrainingBehavioural
A therapist will be used to train power wheelchair users.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Training | Experimental | Participants will receive virtual reality power wheelchair training using VRSim 3.0 in this group. Receives: Other: VRSim 3.0 |
| In-person Therapist Training | Active comparator | Participants will receive in-person wheelchair training by a therapist in this group. Receives: Behavioral: In-Person Wheelchair Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: This outcome measure will be measured at the beginning and end of the study, which may take up to one year to complete.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start19 Jun 2018
- Primary completion2 Aug 2019
- Study completion2 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal DiseasesStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brad Dicianno, University of Pittsburgh
- Investigators
- Brad E Dicianno, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03562455
- Sponsor's protocol ID
- PRO18010297
- Status last verified
- Aug 2022
- First submitted
- 22 May 2018
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effectiveness of Virtual Reality for Power Wheelchair Driving Training
- ClinicalTrials.gov ID
- NCT03562455
- Acronym / sponsor ID
- PRO18010297
- Conditions
- Spinal Diseases
- Keywords
- Virtual Reality, Wheelchairs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 19 Jun 2018 (actual)
- Primary completion
- 2 Aug 2019 (actual)
- Study completion
- 2 Aug 2019 (actual)
- First posted
- 19 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Training | Experimental | Other: VRSim 3.0Participants will receive virtual reality power wheelchair training using VRSim 3.0 in this group. |
| In-person Therapist Training | Active comparator | Behavioral: In-Person Wheelchair TrainingParticipants will receive in-person wheelchair training by a therapist in this group. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VRSim 3.0VRSim 3.0 is a virtual reality training module. | Other | Virtual Reality Training |
| In-Person Wheelchair TrainingA therapist will be used to train power wheelchair users. | Behavioural | In-person Therapist Training |
Primary outcome
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.
4 secondary outcomes
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brad E Dicianno, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VRSim 3.0 and In-Person Wheelchair Training in people with Spinal Diseases, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2022; AzTrials last refreshed its copy on 29 Oct 2026.