Virtual Walking Therapy for Neuropathic Pain Following Incomplete Spinal Cord Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTexas A&M University
About this trial
The purpose of this study is to determine if playing a virtual reality walking game can help improve neuropathic pain in adults with incomplete spinal cord injury.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Must have persistent NP symptoms that are of daily severity of at least 4/10 for 3 or more months
Must endorse more than 2 items on a 7-item Spinal Cord Injury Pain Instrument, SCIPI
Must be 18 years of age or older
Must be more than one and a half years post-injury to begin study (can be screened at an earlier time for eligibility)
Disqualifiers
Individuals with Injury levels between C1 and C4
Individuals under the age of 18
Individuals who were injured within the past year
Individuals who cannot comprehend spoken English
Trial design
Design model
Parallel
Treatments tested in this trial
VR Game 1
Other interventionIndividuals 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
Other interventionIndividuals 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.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: Virtual reality (VR) game 1Active comparator 1 intervention
Group B: Virtual reality (VR) game 2Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Pain Intensity
The Numeric Rating Scale (NRS) measures pain intensity via a 0-10 numeric rating scale 0-10 where 0 is no pain, and 10 is the worst pain imaginable.
Time frame
Baseline - final follow up (up to 18 months)Secondary outcomes
1
Change in Pain Quality
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. 0 equals 'No sensation' and 10 equals 'Worst sensation imaginable.' All the items are rated 0-10 scale, with a higher score indicative of more neuropathic pain for each type of respective pain.
Time frame
Baseline - final follow up (up to 18 months)2
Change in Pain Interference
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.
Time frame
Baseline - final follow up (up to 18 months)3
Post treatment change
The Patient Global Impression of Change is a one item 7 point Likert item assessing improvement of the participants' overall status. A score of 1 is 'Very Much Improved', and a score of 7 is 'Very Much Worse.' Higher scores indicate less perceived improvement. Range of scores: 1-7
Time frame
at follow up (up to 18 months)4
Change in mood
Mood will be assessed using the Patient Health Questionnaire-9. Participants will be asked to rate how often they have been bothered by specific problems on a 4-point Likert scale, where 0 is 'Not at all,' and 3 is 'Nearly every day.' The items are summed to yield a score ranging from 0-27. Higher scores indicate worse mood.
Time frame
Baseline - final follow up (up to 18 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Texas A&M University
Lead sponsor
United States Department of Defense
Collaborator
Immersive Experience Labs
Collaborator
Source ClinicalTrials.gov