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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05005026




Registration number
NCT05005026
Ethics application status
Date submitted
6/08/2021
Date registered
13/08/2021
Date last updated
19/08/2024

Titles & IDs
Public title
Virtual Walking Intervention for Neuropathic Pain in Spinal Cord Injury
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
Secondary ID [1] 0 0
W81XWH-20-1-0775
Secondary ID [2] 0 0
HM20020719
Universal Trial Number (UTN)
Trial acronym
VRWalk
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Injuries 0 0
Neuropathic Pain 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Fractures
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Neurological 0 0 0 0
Other neurological disorders
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Pain Intensity
Timepoint [1] 0 0
Baseline - final follow up (up to 18 months)
Secondary outcome [1] 0 0
Change in Pain Quality
Timepoint [1] 0 0
Baseline - final follow up (up to 18 months)
Secondary outcome [2] 0 0
Change in Pain Interference
Timepoint [2] 0 0
Baseline - final follow up (up to 18 months)
Secondary outcome [3] 0 0
Post treatment change
Timepoint [3] 0 0
at follow up (up to 18 months)
Secondary outcome [4] 0 0
Change in mood
Timepoint [4] 0 0
Baseline - final follow up (up to 18 months)
Secondary outcome [5] 0 0
Change in quality of life
Timepoint [5] 0 0
Baseline - final follow up (up to 18 months)
Secondary outcome [6] 0 0
Neurological changes
Timepoint [6] 0 0
Baseline - 6 months

Eligibility
Key inclusion criteria
The study will recruit individuals with complete injury (American Spinal Injury Association [ASIA] classification A) with lumbar, paraplegic, or low tetraplegic (C5-C7) injury. Additional criteria will include:

1. Must have persistent NP symptoms that are of daily severity of at least 4/10 for 3 or more months
2. Must endorse more than 2 items on a 7-item Spinal Cord Injury Pain Instrument, SCIPI
3. Must be 18 years of age or older
4. Must be more than one year post-injury to begin study (can be screened at an earlier time for eligibility)
5. Must have mobile connectivity with usable service
6. Must be stable on pain medication for 1 or more months
7. Must be cleared on the VRWalk physical activity clearance scale
8. Must not have motion sickness that interferes with daily life
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Individuals with Injury levels between C1 and C4
2. Individuals under the age of 18
3. Individuals who were injured within the past year
4. Individuals who cannot comprehend spoken English
5. Individuals who are in prison
6. Individuals who are blind
7. Individuals who experience severe motion sickness

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2026
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
University of New South Wales - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Other
Name
Texas A&M University
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
United States Department of Defense
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Richmond VA Medical Center
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Immersive Experience Labs
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT05005026
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Zina Trost, PhD
Address 0 0
Texas A&M University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amanda Sainz-Higgins, M.E.d
Address 0 0
Country 0 0
Phone 0 0
804-569-5965
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05005026