Recruiting

Virtual Walking Intervention

Sponsor:

Texas A&M University

Code:

NCT05005026

Conditions

Spinal Cord Injuries

Neuropathic Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

VR Game 1

VR Game 2

Study Details

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.

Conditions

Spinal Cord Injuries

Neuropathic Pain

Study ID

NCT05005026

Start date

Nov 23, 2021

Status verified date

Sep, 2025

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

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

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

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.

Primary outcome measure

  • Change in Pain Intensity [ Time Frame: Baseline - final follow up (up to 18 months) ]

Central Contacts and Locations

Central contacts

Amanda Sainz-Higgins, M.E.d

804-569-5965sci@vrwalk.org

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Rachel Cowan, PhD

recowan@uabmc.edu

Principal Investigator:

Rachel Cowan, PhD

Texas A&M University

Recruiting

College Station, Texas, United States, 77843

Contacts

sci@vrwalk.org

Principal Investigator:

Zina Trost, PhD

More Information

Sponsor

Texas A&M University

Last update posted

Dec 17, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Texas A&M University on 2025-12-17.