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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05005026
Registration number
NCT05005026
Ethics application status
Date submitted
6/08/2021
Date registered
13/08/2021
Date last updated
22/08/2023
Titles & IDs
Public title
Virtual Walking Intervention for Neuropathic Pain in Spinal Cord Injury
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Scientific title
A Multisite Randomized Clinical Trial to Examine the Efficacy and Mechanisms of Immersive Virtual Walking Treatment for Neuropathic Pain in Spinal Cord Injury
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Secondary ID [1]
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W81XWH-20-1-0775
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Secondary ID [2]
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HM20020719
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Universal Trial Number (UTN)
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Trial acronym
VRWalk
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Injuries
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Neuropathic Pain
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Condition category
Condition code
Injuries and Accidents
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Fractures
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Injuries and Accidents
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Other injuries and accidents
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Neurological
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Other neurological disorders
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Skin
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - VR Game 1
Other interventions - VR Game 2
Active Comparator: Virtual reality (VR) game 1 - Participants will be asked to play a virtual reality game twice a day for 10 days.
Active Comparator: Virtual reality (VR) game 2 - Participants will be asked to play a virtual reality game twice a day for 10 days.
Other interventions: VR Game 1
Individuals playing VR game 1 will wear a head-mounted display to allow them to visualize virtual legs in the virtual environment. When wearing the display, individuals will see the legs and arms of their virtual avatar from a first-person perspective.
Individuals will engage in virtual reality sessions in their home twice daily over the course of 10 days in a two-week period. Each daily session will take approximately 30 minutes, with 5-10 minutes dedicated to the virtual walking experience. Additionally, each daily session will be scheduled a minimum of 4 hours apart.
Other interventions: VR Game 2
Individuals playing VR game 2 will wear a head-mounted display to allow them to visualize virtual legs in the virtual environment. When wearing the display, individuals will see the legs and arms of their virtual avatar from a first-person perspective.
Individuals will engage in virtual reality sessions in their home twice daily over the course of 10 days in a two-week period. Each daily session will take approximately 30 minutes, with 5-10 minutes dedicated to the virtual walking experience. Additionally, each daily session will be scheduled a minimum of 4 hours apart.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in Pain Intensity
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Assessment method [1]
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The Numeric Rating Scale (NRS) measures pain intensity via 0-10 numeric rating scale 0-10 where 0 is no pain and 10 is the worst pain imaginable.
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Timepoint [1]
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Baseline - final follow up (up to 18 months)
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Secondary outcome [1]
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Change in Pain Quality
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Assessment method [1]
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The Neuropathic Pain Scale (NPS) assesses the distinct pain qualities including sharpness, heat/cold, dullness, intensity, overall unpleasantness, and surface vs. deep pain. The NPS consists of 10 items. All the items are rated 0-10 scale, with higher score indicative of more neuropathic pain for each type of respective pain.
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Timepoint [1]
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Baseline - final follow up (up to 18 months)
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Secondary outcome [2]
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Change in Pain Interference
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Assessment method [2]
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The International Spinal Cord Injury Pain Basic Data Set version 2.0 interference assesses the degree to which pain interferes with day-to-day activities, mood, and sleep. Items are scored on a 0-10 numeric rating scale and scores are summed to yield an interference score ranging from 0 to 30. Higher scores indicate greater interference from pain.
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Timepoint [2]
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Baseline - final follow up (up to 18 months)
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Secondary outcome [3]
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Post treatment change
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Assessment method [3]
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The Patient Global Impression of Change is a one item 7 point Likert item assessing improvement of the participants overall status. Higher scores indicate less perceived improvement.
Range of scores: 1-7
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Timepoint [3]
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at follow up (up to 18 months)
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Secondary outcome [4]
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Change in mood
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Assessment method [4]
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Mood will be assessed using the Patient Health Questionnaire-9. Participants will be asked to rate have how often they have been bothered by specific problems on a 4-point Likert scale. The items are summed to yield a score ranging from 0-27. Higher scores indicate worse mood.
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Timepoint [4]
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Baseline - final follow up (up to 18 months)
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Secondary outcome [5]
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Change in quality of life
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Assessment method [5]
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Quality of life is assessed by the Satisfaction with Life Scale. This is a 5 item survey. Response options are a 7-point Likert scale. Items may be assessed individually or by summing items.
Range of scores: 5-35. Higher scores indicate more satisfaction in life
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Timepoint [5]
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Baseline - final follow up (up to 18 months)
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Secondary outcome [6]
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Neurological changes
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Assessment method [6]
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Functional Magnetic Resonance Imaging (fMRI) will be used to observe neurological changes. Pre and post study images will be compared by experienced researchers.
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Timepoint [6]
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Baseline - 6 months
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Eligibility
Key inclusion criteria
- The study will recruit individuals with complete and incomplete injury (American
Spinal Injury Association [ASIA] classification A, B, C, D) with lumbar, paraplegic,
or low tetraplegic (C5-C7) injury. Additional criterial will include:
1. persistent NP symptoms that are of daily severity of at least 4/10 for 3 or more
months
2. endorsement of more than 2 items on a 7-item Spinal Cord Injury Pain Instrument,
SCIPI
3. age of 18 or older
4. more than one-year post-injury
5. neuropathic pain during the last 7 days
6. ability to move elbows against gravity
7. must have mobile connectivity with usable service)
8. SCIPI and DN4 scores for neuropathic pain must be 2 or more
9. must be stable on pain medication for 1 or more months
10. must be cleared on the VRWalk physical activity clearance scale
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Not meeting injury type criteria
2. Not meeting NP criteria
3. Age 17 or less
4. Less than a year following injury
5. Inability to comprehend spoken English
6. Prisoners
7. must not have motion sickness that interferes with daily life
8. blind
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
23/11/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/09/2026
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Actual
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Sample size
Target
250
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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University of New South Wales - Sydney
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Recruitment postcode(s) [1]
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- Sydney
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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Country [2]
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United States of America
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State/province [2]
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Virginia
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Funding & Sponsors
Primary sponsor type
Other
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Name
Virginia Commonwealth University
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Address
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Country
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Other collaborator category [1]
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Government body
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Name [1]
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United States Department of Defense
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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McGuire Veterans Hospital
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Immersive Experience Labs
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Address [3]
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Country [3]
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to determine if playing a virtual reality walking game can help
improve neuropathic pain in adults with chronic spinal cord injury.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05005026
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Zina Trost, PhD
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Address
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Virginia Commonwealth University
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Hannah Palanchi
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Address
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Country
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Phone
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804-569-5965
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05005026
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