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Severe Mobility ImpairmentNCT07820618

Effects of Virtual Walking on Chronic Pain and Psychological Distress for Individuals With Severe Mobility Impairment

A study testing Virtaul walking and Passive observing video in people with Severe Mobility Impairment and Spinal Cord Injuries (SCI), run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
Virtaul walking and Passive observing video
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteHong Kong
Study dates
2 Apr 2026to 1 Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • People with SMI (the operational definition of SMI is inability to walk 4 meters in less than 10 seconds, or self-, proxy-, or medical record reported inability to walk across a small room, or dependence on a walking aid during walking for more than 6 months (Pahor et al., 2014));
  • At least 6 months post-injury and in stable status;
  • Persistent chronic pain (more than 3 months) with a reported Numerical Pain Rating Scale ≥ 4 (Villiger et al., 2017);
  • Had no changes in their pain medication regimen in the past month;
  • Able to communicate in Cantonese and to provide informed consent.

Who cannot join

  • Have severe cognitive impairment (a score < 6 on the Abbreviated Mental Test (Chu et al., 1995));
  • Had a history of moderate to severe brain injury;
  • Have neurological disorders which affect brain function (i.e., stroke, Alzheimer's, Parkinson's, epilepsy) that may confound EEG measures;
  • Have a severe psychiatric disorder (schizophrenia or major depression);
  • Have an upper limb condition influencing the use of VR (e.g., arthritis or upper limb amputation).

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • School of Nursing, The Hong Kong Polytechnic University, Hong Kong

    Hung Hom

Other trials in Hong Kong

About this study

Official title: Effects of Virtual Walking on Chronic Pain and Psychological Distress for Individuals With Severe Mobility Impairment: A Pilot Randomized Controlled Trial and Electroencephalogram Study

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.

Read the detailed description

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:

  • Virtual walking group: Participants will engage in an arm-swing virtual walking intervention. This consists of a 13-minute session daily for 10 days.
  • Control group: Participants will receive a time-matched passive video observing control, watching walking videos for 13 minutes daily for 10 days.

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.

Being tested
Virtaul walking, Passive observing video
Keywords
Virtual reality, Chronic pain, Psychological distress, Quality of life
Medical subject headings
Spinal Cord Injuries, Poliomyelitis, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtaul walkingBehavioural

    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).

  • Passive observing videoBehavioural

    Participants in the control group will watch 10 different walking videos in total, one for each day, each approximately 13 minutes.

Study groups in NCT07820618
Study groupRoleWhat they receive
Virtual walking groupExperimentalParticipants in the virtual walking group will experience virtual walking in 10 virtual natural scenarios by using arm swing locomotion.
Receives: Behavioral: Virtaul walking
Passive observing video groupActive comparatorParticipants in the passive observing group will look at 10 matched walking videos.
Receives: Behavioral: Passive observing video

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline (T0), and up to 48 hours post-intervention (T1).

  2. 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.

    Measured: Baseline (T0), and up to 48 hours post-intervention (T1).

Secondary outcomes (5)

  1. 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).

    Measured: Baseline (T0), and up to 48 hours post-intervention (T1).

  2. 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.

    Measured: Baseline (T0), and up to 48 hours post-intervention (T1).

  3. 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.

    Measured: Baseline (T0), and up to 48 hours post-intervention (T1).

  4. 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.

    Measured: Baseline (T0), and up to 48 hours post-intervention (T1).

  5. 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.

    Measured: Baseline (T0), and up to 48 hours post-intervention (T1).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2026
  2. Study start2 Apr 2026
  3. Primary completion1 Mar 2027 (estimated)
  4. Study completion1 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07820618
Sponsor's protocol ID
HSEARS20251111003
Status last verified
Apr 2026
First submitted
27 May 2026
Last updated
15 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chu, L., Pei, C., Ho, M., & Chan, P. (1995). Validation of the abbreviated mental test (Hong Kong version) in the elderly medical patient.

  • Pahor M, Guralnik JM, Ambrosius WT, Blair S, Bonds DE, Church TS, Espeland MA, Fielding RA, Gill TM, Groessl EJ, King AC, Kritchevsky SB, Manini TM, McDermott MM, Miller ME, Newman AB, Rejeski WJ, Sink KM, Williamson JD; LIFE study investigators. Effect of structured physical activity on prevention of major mobility disability in older adults: the LIFE study randomized clinical trial. JAMA. 2014 Jun 18;311(23):2387-96. doi: 10.1001/jama.2014.5616.

    PubMed 24866862

  • Zhao J, Chau JPC, Lo SHS, Choi KC, Liang S. The effects of sitting Tai Chi on physical and psychosocial health outcomes among individuals with impaired physical mobility: A systematic review and meta-analysis. Int J Nurs Stud. 2021 Jun;118:103911. doi: 10.1016/j.ijnurstu.2021.103911. Epub 2021 Mar 3.

    PubMed 33751992

  • Yu W, Singh SS, Calhoun S, Zhang H, Zhao X, Yang F. Generalized anxiety disorder in urban China: Prevalence, awareness, and disease burden. J Affect Disord. 2018 Jul;234:89-96. doi: 10.1016/j.jad.2018.02.012. Epub 2018 Feb 21.

    PubMed 29524751

  • Wang S, Yao S, Shang L, Xu C, Ma J. Validation of the Chinese version of the Brief Pain Inventory in patients with knee osteoarthritis. J Orthop Surg Res. 2023 Sep 23;18(1):720. doi: 10.1186/s13018-023-04218-1.

    PubMed 37742029

  • Vahedi S. World Health Organization Quality-of-Life Scale (WHOQOL-BREF): Analyses of Their Item Response Theory Properties Based on the Graded Responses Model. Iran J Psychiatry. 2010 Fall;5(4):140-53.

    PubMed 22952508

  • Stacy, A. B., Dakota, B. B., & Vaughan, W. I. (2013). Simulator Sickness Questionnaire: Twenty Years Later. Driving Assessment Conference Archive

  • Snyder, D. (1992). Pain: Clinical Manual for Nursing Practice. By Margo McCaffery and Alexandra Beebe. St. Louis: C.V. Mosby Company, 1989, 353 pp., 25.95 (softcover). Cancer Nursing, 15(3), 211.

  • Schubert, T., Friedmann, F., & Regenbrecht, H. (2001). The Experience of Presence: Factor Analytic Insights. Presence: Teleoperators and Virtual Environments, 10(3), 266-281. https://doi.org/10.1162/105474601300343603

  • Schaffarczyk M, Rogers B, Reer R, Gronwald T. Validity of the Polar H10 Sensor for Heart Rate Variability Analysis during Resting State and Incremental Exercise in Recreational Men and Women. Sensors (Basel). 2022 Aug 30;22(17):6536. doi: 10.3390/s22176536.

    PubMed 36081005

Questions about this trial

What is this clinical trial studying?

A study testing Virtaul walking and Passive observing video in people with Severe Mobility Impairment and Spinal Cord Injuries (SCI), run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Chronic pain (time frame: Baseline (T0), and up to 48 hours post-intervention (T1).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07820618, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.

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