NCT07820618

Brief 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 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Apr 2026Apr 2027

Study Start

First participant enrolled

April 2, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2026

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 15, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

September 15, 2026

Status Verified

April 1, 2026

Enrollment Period

11 months

First QC Date

May 27, 2026

Last Update Submit

September 14, 2026

Conditions

PoliomyelitisSevere Mobility ImpairmentSpinal Cord Injuries (SCI)

Keywords

Virtual realityChronic painPsychological distressQuality of life

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

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

Secondary Outcomes (5)

  • Depression

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

  • Anxiety

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

  • Stress

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

  • Quality of life (WHOQOL-100)

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

  • Brain electrocortical activity

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

Other Outcomes (4)

  • Neuropathic pain symptoms

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

  • Heart rate variability (HRV)

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

  • VR experience

    48-hour post-intervention (T1)

  • +1 more other outcomes

Study Arms (2)

Virtual walking group

EXPERIMENTAL

Participants in the virtual walking group will experience virtual walking in 10 virtual natural scenarios by using arm swing locomotion.

Behavioral: Virtaul walking

Passive observing video group

ACTIVE COMPARATOR

Participants in the passive observing group will look at 10 matched walking videos.

Behavioral: Passive observing video

Interventions

Virtaul walkingBEHAVIORAL

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).

Virtual walking group
Passive observing videoBEHAVIORAL

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

Passive observing video group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hung Hom, Hong Kong

Location

Related Publications (10)

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

    BACKGROUND

  • 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.

    PMID: 24866862BACKGROUND

  • 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.

    PMID: 33751992BACKGROUND

  • 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.

    PMID: 29524751BACKGROUND

  • 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.

    PMID: 37742029BACKGROUND

  • 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.

    PMID: 22952508BACKGROUND

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

    BACKGROUND

  • 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.

    BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 36081005BACKGROUND

MeSH Terms

Conditions

Spinal Cord InjuriesPoliomyelitisChronic Pain

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesMyelitisCentral Nervous System InfectionsInfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesNeuroinflammatory DiseasesNeuromuscular DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2026

First Posted

September 15, 2026

Study Start

April 2, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

September 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)