An interventional study of Virtaul walking and Passive observing video in Severe Mobility Impairment, Spinal Cord Injuries (SCI) and Poliomyelitis, sponsored by The Hong Kong Polytechnic University. Active, not recruiting at 1 site in Hong Kong. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Treatment
This randomized controlled trial aims to: (1) examine the effects of virtual walking intervention on chronic pain (primary outcome), and on depression, stress, anxiety, and quality of life (secondary outcomes) compared with the passive observing video control group in individuals with SMI (primarily spinal cord injury and post-polio); (2) explore the neurological mechanism of virtual walking intervention using the resting-state and task-based electroencephalography (EEG); (3) understand their perceived effects, strengths, and limitations for the virtual walking intervention using semi-structured focus group interviews.
Background: Severe mobility impairment (SMI) negatively impacts lifespan and quality of life, especially through chronic pain and emotional issues such as depressive symptoms. Researchers have developed treatments including pharmacological interventions, physical activities, complementary and alternative medicine, and psychological treatment to treat chronic pain and emotional issues. However, these approaches have limitations. Virtual walking interventions utilize arm-swing locomotion to create the illusion of walking, allowing individuals to experience walking in virtual natural scenes. These interventions have shown feasibility and preliminary effects on mood and pain reduction in people with spinal cord injury. However, prior work varies in locomotion design (e.g., passive observing, trigger-based, or arm-swing), dosage (session length and total dose), and a few studies incorporate objective biomarkers like EEG to test neurological mechanisms.
Thus, this study aims to examine the effects of virtual walking on chronic pain and psychological distress and to explore the neurological mechanisms of virtual walking using the resting-state and task-based EEG.
Design:
This study will be a single-blind, two-arm, parallel-group pilot randomized controlled trial (RCT).
Participants and Subgroup Stratification:
Forty-eight participants experiencing chronic pain will be recruited from the Hong Kong Polytechnic University. At baseline, all recruited participants will be screened for neuropathic pain using the Douleur Neuropathique 4 Questions (DN4) questionnaire. Participants who score ≥4 will be classified into a neuropathic pain subgroup. To facilitate mechanism-based subgroup analysis in the EEG data processing, only participants in this specific subgroup will undergo an additional Quantitative Sensory Testing (QST, Medoc) at baseline. Besides, another healthy control group will be added to provide a normative reference for exploratory mechanistic analyses.
Interventions:
Participants will be randomly assigned to one of two arms:
Instruments: Validated questionnaires, 64-channel EEG, and HRV monitoring.
Qualitative Evaluation:
Following the completion of the intervention, qualitative semi-structured interviews will be conducted with participants to explore their perceived effects, strengths, and limitations of the intervention.
2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.
This study's planned enrollment of 48 is above the median of 24 across 1,633 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →The Hong Kong Polytechnic University is the lead sponsor of 679 studies on the registry; 257 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in the virtual walking group will experience virtual walking in 10 virtual natural scenarios by using arm swing locomotion.
Behavioral: Virtaul walking
Participants in the passive observing group will look at 10 matched walking videos.
Behavioral: Passive observing video
Participants in the intervention group will wear a head-mounted display and hold a controller to swing their arm and control the virtual avatar walking in the virtual natural scenarios. The intervention will include 10 scenarios of virtual walking intervention (1 scenario daily, each lasting for 13 minutes).
Participants in the control group will watch 10 different walking videos in total, one for each day, each approximately 13 minutes.
Chronic pain
Chronic pain will be assessed using the Brief Pain Inventory (BPI). Mean scores of items 3 - 6 (pain severity) and 9A-9G (pain interference) are calculated. Each item is rated on a 0-10 scale. Higher scores indicate greater pain severity and interference with daily life.
Time frame: Baseline (T0), and up to 48 hours post-intervention (T1).
Chronic pain
Chronic pain will be assessed using the Numeric Pain Rating Scale (NPRS). The NPRS is an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate higher pain intensity.
Time frame: Baseline (T0), and up to 48 hours post-intervention (T1).
Depression
Depression will be measured using the 9-item Patient Health Questionnaire (PHQ-9). Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms (0-4 minimal, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe).
Time frame: Baseline (T0), and up to 48 hours post-intervention (T1).
Anxiety
Anxiety symptoms will be measured using the Generalized Anxiety Disorder 7-item (GAD-7). The GAD-7 consists of 7 items rated on a Likert scale from 0 to 3 (0 = not at all, 3 = nearly every day), with scores ranging from 0 to 21; higher scores indicate a higher level of anxiety severity.
Time frame: Baseline (T0), and up to 48 hours post-intervention (T1).
Stress
Stress will be measured using the Chinese version of the Perceived Stress Scale (PSS-10). The PSS-10 consists of 10 items rated on a 5-point Likert scale (0 = never to 4 = very often), with total scores ranging from 0 to 40; higher scores indicate higher levels of perceived stress.
Time frame: Baseline (T0), and up to 48 hours post-intervention (T1).
Quality of life (WHOQOL-100)
Quality of life will be measured using the Chinese version of the World Health Organization Quality of Life (WHOQOL-100). The WHOQOL consisted of 100 items from six domains: physical, psychological, level of independence, social relationships, environmental, and spiritual belief. The total score of each domain will be converted to 0 - 100, with higher scores indicating higher QOL.
Time frame: Baseline (T0), and up to 48 hours post-intervention (T1).
Brain electrocortical activity
Brain electrophysiological activity will be assessed using a 64-channel electroencephalography (EEG) system (Neuroscan) at rest and during task-based states. At rest, EEG outcomes will include absolute and relative spectral power in the delta (1-4 Hz), theta (4-8 Hz), alpha (8-13 Hz), beta (13-30 Hz), and gamma (30-45 Hz) frequency bands. Alpha peak frequency will also be included. During the task-based assessment, event-related spectral perturbation (ERSP) will be calculated to assess event-related changes in spectral power within the pre-specified alpha (8-13 Hz) and beta (13-30 Hz) frequency bands.
Time frame: Baseline (T0), and up to 48 hours post-intervention (T1).
Neuropathic pain symptoms
Neuropathic pain symptoms will be assessed using the Neuropathic Pain Scale (NPS) in a specific subgroup of participants previously screened with neuropathic pain features using the Douleur Neuropathique 4 Questions (DN4) questionnaire (DN4 score ≥ 4). The NPS assesses distinct neuropathic pain qualities. Each item is rated from 0 to 10, with higher scores indicating greater severity of the corresponding neuropathic pain symptom.
Time frame: Baseline (T0), and up to 48 hours post-intervention (T1).
Heart rate variability (HRV)
Heart rate variability (HRV) will be measured using a Polar H10 chest strap and analyzed using the Elite HRV application concurrently with EEG recording. The pre-specified HRV outcomes will be two time-domain indices: (1) the standard deviation of normal-to-normal intervals (SDNN), expressed in milliseconds; and (2) the root mean square of successive differences between normal-to-normal intervals (RMSSD), expressed in milliseconds. Higher SDNN and RMSSD values generally indicate greater heart rate variability under comparable recording conditions.
Time frame: Baseline (T0), and up to 48 hours post-intervention (T1).
VR experience
VR experience will be assessed post-intervention using the Igroup Presence Questionnaire (IPQ), a VR-specific process outcome measure. The IPQ includes three subscales-Spatial Presence, Involvement, and Experienced Realism-and one general presence item. Items are scored on a 7-point scale ranging from -3 to +3, with higher scores indicating a greater sense of presence in the virtual environment.
Time frame: 48-hour post-intervention (T1)
Simulator sickness symptoms
Simulator Sickness Questionnaire (SSQ) will be used to assess individuals' susceptibility to VR at a symptomatic level. SSQ will be assessed post-intervention in the VR arm as a VR-specific process outcome. The SSQ contains 16 items, each rated on a 4-point scale from 0 (none) to 3 (severe). Higher scores indicate more severe simulator sickness symptoms.
Time frame: 48-hour post-intervention (T1).
Plan to share: No
Started Apr 2026 (actual). Primary completion is estimated for Mar 2027, 10 months after the start.
Of 790 non-industry interventional studies with no phase under Spinal Cord Injuries, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 65. This study's planned 10 months is below that.
Counting every sponsor, half of 839 studies reached it within 36 months; a quarter within 17 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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