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Knee OsteoarthritisNCT07920120

Effects of Virtual Reality Environments on Walking in Adults With and Without Knee Osteoarthritis

A study testing Immersive Virtual Reality Walking Conditions and Non-VR Walking in people with Knee Osteoarthritis, run by University of Primorska at 2 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Knee osteoarthritis (KOA) is a common musculoskeletal condition associated with pain, impaired physical function, and movement-related fear. Psychological factors, particularly fear of movement (kinesiophobia), may influence movement behavior and limit participation in physical activity and exercise therapy. Read more about this study

Who is it for?
Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for
Knee Osteoarthritis
What is being tested?
Immersive Virtual Reality Walking Conditions and Non-VR Walking
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesin 2 countries
Study dates
26 Aug 2026to 30 Nov 2026
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 50 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age 50 years or older.
  • Diagnosis of knee osteoarthritis in one or both knees, confirmed according to the clinical and radiographic criteria of the American College of Rheumatology.
  • Knee pain and radiographically confirmed osteophytes, together with at least one of the following: age over 50 years, morning stiffness lasting less than 30 minutes, or crepitus during active knee movement.
  • Age 50 years or older.
  • No significant gait disturbances.

Who cannot join

  • Participants will be excluded from the studies if they:
  • are younger than 50 years;
  • are on a waiting list for knee arthroplasty within the next year;
  • have sustained an acute knee injury within the previous 6 months;
  • have knee pain unrelated to KOA;
  • have a knee or hip arthroplasty;
Show all 18Show fewer
  • have undergone surgery of the back, hip, knee, ankle, or foot within the previous 12 months;
  • have health conditions or musculoskeletal limitations that affect strengthening exercise and limit physical function to a greater extent than knee pain (e.g., low back pain or hip pain);
  • have concomitant systemic inflammatory diseases such as rheumatoid arthritis or gout; neurological conditions (Alzheimer's disease, Parkinson's disease, or metabolic diseases affecting the nervous system); muscular or joint diseases/injuries affecting lower-limb function (e.g., osteoarthritis of the hip and/or ankle, sprains, fractures); or internal medical conditions (cardiovascular, pulmonary and/or oncological diseases, or diabetes with late complications such as diabetic foot or neuropathy) that affect physical capacity;
  • have a history of stroke or myocardial infarction resulting in motor and/or cognitive impairments (including inability to provide informed consent);
  • have balance disorders known to be caused by vestibular dysfunction;
  • have a body mass index (BMI) >32 kg/m²;
  • have received intra-articular corticosteroid and/or hyaluronic acid injections within the previous 6 months;
  • have diagnosed epilepsy or a history of epileptic seizures, particularly photosensitive epilepsy;
  • experience frequent or severe migraines triggered by visual stimuli;
  • have severe visual impairments that are not adequately corrected;
  • have previously experienced pronounced adverse effects when using virtual reality (e.g., severe nausea, vomiting, marked dizziness, or severe disorientation).
  • Healthy Control Group:

Trial locations and contacts

2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

2 sites in 2 countries

Lithuania1 site
  • Vilnius Gediminas Technical University

    Vilnius

    Completed

Other trials in Lithuania

Slovenia1 site, 1 recruiting
  • University of Primorska, Faculty of Health Sciences

    Izola, 6310

    Nejc Šarabon, +386 05/66-26-460, nejc.sarabon@fvz.upr.si

    Recruiting

Other trials in Slovenia

About this study

Official title: Validation of VR Strategies for Knee Osteoarthritis Rehabilitation

Knee osteoarthritis (KOA) is a common musculoskeletal condition associated with pain, impaired physical function, and movement-related fear. Psychological factors, particularly fear of movement (kinesiophobia), may influence movement behavior and limit participation in physical activity and exercise therapy. Immersive virtual reality (VR) provides an opportunity to modify the visual environment and potentially influence how individuals perceive safety and threat during movement. However, it remains unclear how VR-induced perceptions of safety and fear affect gait biomechanics, particularly in individuals with KOA.

The aim of this study is to investigate the effects of immersive VR environments designed to promote safety or induce fear on gait biomechanics and psychological responses in individuals with KOA and healthy adults aged 50 years and older.

Read more

Participants will perform walking tasks under five experimental conditions: walking without VR, walking in a neutral VR environment, walking in a safety-promoting VR environment on low ground, walking in a fear-inducing VR environment, and walking in a safety-promoting VR environment on high ground.

During each condition, participants will walk along a straight 6-meter walkway at their preferred comfortable speed. Gait biomechanics will be assessed using an inertial motion capture system and force platforms. The primary outcome will be gait speed. Additional biomechanical parameters and subjective responses, including perceived fear, safety, and VR-related experiences, will also be assessed.

The study aims to determine whether VR environments that alter perceived safety and fear influence walking patterns and whether these responses differ between individuals with KOA and healthy adults. It is hypothesized that fear-inducing VR environments will alter gait biomechanics, particularly gait speed, compared with neutral and safety-promoting conditions.

Being tested
Immersive Virtual Reality Walking Conditions, Non-VR Walking
Keywords
virtual reality, knee osteoarthritis, Gait Biomechanics, Kinesiophobia, Fear of Falling, Gait Speed
Medical subject headings
Osteoarthritis, Knee, Kinesiophobia

What participants receive

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

  • Immersive Virtual Reality Walking ConditionsBehavioural

    Participants perform repeated walking trials in four immersive virtual reality (VR) environments presented through a head-mounted display (Vive Focus 3): (1) a neutral environment, (2) a safety-promoting environment on low ground, (3) a fear-inducing environment, and (4) a safety-promoting environment on high ground. Each condition involves walking along a straight 6-meter walkway at a self-selected comfortable speed. At least five valid trials are collected per condition whenever feasible, with a minimum of three valid trials accepted if limited by pain, fatigue, or VR discomfort. The environments are designed to manipulate perceived safety and fear during walking.

  • Non-VR WalkingBehavioural

    Participants perform overground walking without a virtual reality headset along a straight 6-meter walkway at a self-selected comfortable speed. At least five valid walking trials are collected whenever feasible, with a minimum of three valid trials accepted if limited by pain or fatigue. This condition serves as the control for comparison with the four immersive VR walking conditions.

Study groups in NCT07920120
Study groupRoleWhat they receive
VR and Non-VR Walking ConditionsExperimentalAll participants, including individuals with knee osteoarthritis and healthy controls, complete five walking conditions: (1) walking without virtual reality (VR), (2) walking in a neutral VR environment, (3) walking in a safety-promoting VR environment on low ground, (4) walking in a fear-inducing VR environment, and (5) walking in a safety-promoting VR environment on high ground. Participants walk along a straight 6-meter walkway at a self-selected comfortable speed, with at least five valid walking trials per condition whenever feasible. Gait biomechanics and subjective responses are assessed across all conditions.
Receives: Behavioral: Immersive Virtual Reality Walking Conditions; Behavioral: Non-VR Walking

What is being measured

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

  1. Gait Speed

    Mean gait speed (m/s) during overground walking, measured using the Xsens MVN Awinda inertial motion capture system. Gait speed will be calculated as the average across valid walking trials for each of the five experimental conditions (one non-VR and four VR conditions).

    Measured: Day 1 (during the single experimental session, assessed during each of the five walking conditions).

Secondary outcomes (24)
  1. Cadence

    Cadence (steps/min) measured using the Xsens MVN Awinda inertial motion capture system. Mean cadence will be calculated across valid walking trials for each of the five experimental conditions.

    Measured: Day 1 (during the single experimental session, assessed during each of the five walking conditions).

  2. Stride Length

    Mean stride length (m), defined as the distance covered during one complete stride, measured using the Xsens MVN Awinda inertial motion capture system and averaged across valid trials in each walking condition.

    Measured: Day 1 (during the single experimental session, assessed during each of the five walking conditions).

  3. Stride Time

    Mean stride time (s), defined as the duration of one complete gait cycle, measured using the Xsens MVN Awinda inertial motion capture system and averaged across valid trials in each walking condition.

    Measured: Day 1 (during the single experimental session, assessed during each of the five walking conditions).

  4. Step Width

    Mean step width (m), defined as the mediolateral distance between the feet during walking, measured using the Xsens MVN Awinda inertial motion capture system and averaged across valid trials in each walking condition.

    Measured: Day 1 (during the single experimental session, assessed during each of the five walking conditions).

  5. Stance Phase Duration

    Mean stance phase duration, expressed as a percentage of the gait cycle (%), measured using the Xsens MVN Awinda inertial motion capture system and averaged across valid trials in each walking condition.

    Measured: Day 1 (during the single experimental session, assessed during each of the five walking conditions).

  6. Swing Phase Duration

    Mean swing phase duration, expressed as a percentage of the gait cycle (%), measured using the Xsens MVN Awinda inertial motion capture system and averaged across valid trials in each walking condition.

    Measured: Day 1 (during the single experimental session, assessed during each of the five walking conditions).

  7. Double Support Duration

    Mean double support duration, expressed as a percentage of the gait cycle (%), measured using the Xsens MVN Awinda inertial motion capture system and averaged across valid trials in each walking condition.

    Measured: Day 1 (during the single experimental session, assessed during each of the five walking conditions).

  8. First Vertical Ground Reaction Force Peak

    First vertical ground reaction force peak during weight acceptance, measured using force platforms, normalized to body weight, and averaged across valid trials in each walking condition.

    Measured: Day 1 (during the single experimental session, assessed during each of the five walking conditions).

  9. Second Vertical Ground Reaction Force Peak

    Second vertical ground reaction force peak during push-off, measured using force platforms, normalized to body weight, and averaged across valid trials in each walking condition.

    Measured: Day 1 (during the single experimental session, assessed during each of the five walking conditions).

  10. Mid-Stance Minimum Vertical Ground Reaction Force

    Minimum vertical ground reaction force during mid-stance, measured using force platforms, normalized to body weight, and averaged across valid trials in each walking condition.

    Measured: Day 1 (during the single experimental session, assessed during each of the five walking conditions).

  11. Hip Sagittal Range of Motion

    Hip flexion-extension range of motion during walking, expressed in degrees, measured using the Xsens MVN Awinda inertial motion capture system and averaged across valid trials in each walking condition.

    Measured: Day 1 (during the single experimental session, assessed during each of the five walking conditions).

  12. Knee Sagittal Range of Motion

    Knee flexion-extension range of motion during walking, expressed in degrees, measured using the Xsens MVN Awinda inertial motion capture system and averaged across valid trials in each walking condition.

    Measured: Day 1 (during the single experimental session, assessed during each of the five walking conditions).

  13. Ankle Sagittal Range of Motion

    Ankle dorsiflexion-plantarflexion range of motion during walking, expressed in degrees, measured using the Xsens MVN Awinda inertial motion capture system and averaged across valid trials in each walking condition.

    Measured: Day 1 (during the single experimental session, assessed during each of the five walking conditions).

  14. Step Time Variability

    Variability in step time during walking, assessed using the Xsens MVN Awinda inertial motion capture system and expressed as the coefficient of variation (%). Variability is calculated across consecutive steps within each experimental condition.

    Measured: Day 1 (during the single experimental session, assessed during each of the five walking conditions).

  15. Stance Time Variability

    Variability in stance phase duration during walking, assessed using the Xsens MVN Awinda inertial motion capture system. Variability is calculated across consecutive gait cycles within each experimental condition.

    Measured: Day 1 (during the single experimental session, assessed during each of the five walking conditions).

  16. Step Width Variability

    Variability in the mediolateral distance between the feet during walking, assessed using the Xsens MVN Awinda inertial motion capture system across consecutive steps within each experimental condition.

    Measured: Day 1 (during the single experimental session, assessed during each of the five walking conditions).

  17. Gait Symmetry Index

    Left-right symmetry of gait, assessed using inertial motion capture and/or ground reaction force data. The index represents differences between the lower limbs in loading or stance time across experimental conditions.

    Measured: Day 1 (during the single experimental session, assessed during each of the five walking conditions).

  18. Pain Intensity

    Pain intensity is assessed in participants with knee osteoarthritis using an 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Participants rate their pain after each of the five walking conditions.

    Measured: Day 1 (immediately after each of the five walking conditions during the single experimental session).

  19. Perceived Fear and Safety During Walking

    Perceived fear and safety during walking are assessed using a custom questionnaire after each of the five walking conditions in participants with knee osteoarthritis and healthy controls. Perceived fear is rated on a 7-point scale ranging from 1 (no fear at all) to 7 (extreme fear), with higher scores indicating greater fear (a worse outcome). Perceived safety is rated on a separate 7-point scale ranging from 1 (not at all safe) to 7 (completely safe), with higher scores indicating greater perceived safety (a better outcome). The two ratings are reported separately and are not combined into a total score.

    Measured: Day 1 (immediately after each of the five walking conditions during the single experimental session).

  20. Kinesiophobia

    Movement-related fear is assessed in participants with knee osteoarthritis using the 17-item Tampa Scale for Kinesiophobia (TSK-17). The questionnaire evaluates fear of movement and reinjury associated with physical activity. Total scores range from 17 to 68, with higher scores indicating greater kinesiophobia (a worse outcome).

    Measured: Day 1 (at baseline, before the walking experiments).

  21. Health-Related Quality of Life (SF-36)

    Health-related quality of life is assessed in participants with knee osteoarthritis using the 36-Item Short Form Health Survey (SF-36). The questionnaire evaluates eight domains of physical and mental health. Each domain is scored from 0 to 100, with higher scores indicating better health-related quality of life.

    Measured: Day 1 (at baseline, before the walking experiments).

  22. Sense of Presence in Virtual Reality

    The subjective sense of presence within the virtual environment is assessed using the 14-item Igroup Presence Questionnaire (IPQ) after each of the four immersive VR walking conditions. The questionnaire assesses spatial presence, involvement, and experienced realism, with an additional item assessing general presence. Items are rated on a 7-point scale from -3 to +3. After appropriate reverse coding, mean subscale scores and the general presence item score range from -3 to +3, with higher scores indicating a stronger sense of presence in the virtual environment.

    Measured: Day 1 (immediately after each of the four VR walking conditions during the single experimental session).

  23. Perceived Immersion in Virtual Reality

    The subjective level of immersion in the virtual environment is assessed using a 3-point immersion rating scale adapted from Cole et al. after each of the four immersive VR walking conditions. Scores range from 1 to 3: 1 indicates awareness of the technology, 2 indicates partial awareness of the technology and a feeling of being inside the virtual environment, and 3 indicates complete virtual immersion. Higher scores indicate greater subjective immersion.

    Measured: Day 1 (immediately after each of the four VR walking conditions during the single experimental session).

  24. Virtual Reality Sickness Symptoms

    Symptoms associated with virtual reality exposure are assessed using the 9-item Virtual Reality Sickness Questionnaire (VRSQ) before the VR walking conditions and immediately after completion of the final VR condition. Each symptom is rated from 0 (none) to 3 (severe). The total score is calculated as the average of the oculomotor and disorientation subscale scores, each standardized to a range of 0-100. Total scores range from 0 to 100, with higher scores indicating more severe virtual reality sickness symptoms (a worse outcome).

    Measured: Day 1 (before the VR walking conditions and immediately after completion of the final VR condition).

Timeline

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

  1. First posted5 Nov 2026
  2. Study start26 Aug 2026
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion30 Nov 2026 (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
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07920120
Sponsor's protocol ID
BIL-VILT-2026-01
Other IDs
0120-160/2026-2711-3
Status last verified
Nov 2026
First submitted
26 Oct 2026
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data underlying the published findings will be available upon reasonable request. These may include participant characteristics, derived gait parameters, and questionnaire scores collected during the non-VR and VR walking conditions in participants with knee osteoarthritis and healthy controls.

Questions about this trial

What is this clinical trial studying?

A study testing Immersive Virtual Reality Walking Conditions and Non-VR Walking in people with Knee Osteoarthritis, run by University of Primorska at 2 sites in 2 countries.

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 18 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: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Lithuania, Slovenia. 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?

Contact Nejc Šarabon (+386 05/66-26-460, nejc.sarabon@fvz.upr.si), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gait Speed (time frame: Day 1 (during the single experimental session, assessed during each of the five walking conditions).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 5 Nov 2026.

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