An interventional study of Immersive Virtual Reality Walking Conditions and Non-VR Walking in Knee Osteoarthritis, sponsored by University of Primorska. Recruiting at 2 sites in 2 countries. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by University of Primorska · Not applicable, Interventional, and Basic science
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.
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.
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.
This study's planned enrollment of 60 is below the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →University of Primorska is the lead sponsor of 56 studies on the registry; 7 are open to participants now.
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Knee Osteoarthritis (KOA) Group:
Inclusion criteria:
Exclusion criteria:
Participants will be excluded from the studies if they:
Healthy Control Group:
Inclusion 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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All 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.
Behavioral: Immersive Virtual Reality Walking Conditions · Behavioral: Non-VR Walking
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.
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.
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).
Time frame: Day 1 (during the single experimental session, assessed during each of the five walking conditions).
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.
Time frame: Day 1 (during the single experimental session, assessed during each of the five walking conditions).
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.
Time frame: Day 1 (during the single experimental session, assessed during each of the five walking conditions).
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.
Time frame: Day 1 (during the single experimental session, assessed during each of the five walking conditions).
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.
Time frame: Day 1 (during the single experimental session, assessed during each of the five walking conditions).
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.
Time frame: Day 1 (during the single experimental session, assessed during each of the five walking conditions).
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.
Time frame: Day 1 (during the single experimental session, assessed during each of the five walking conditions).
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.
Time frame: Day 1 (during the single experimental session, assessed during each of the five walking conditions).
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.
Time frame: Day 1 (during the single experimental session, assessed during each of the five walking conditions).
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.
Time frame: Day 1 (during the single experimental session, assessed during each of the five walking conditions).
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.
Time frame: Day 1 (during the single experimental session, assessed during each of the five walking conditions).
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.
Time frame: Day 1 (during the single experimental session, assessed during each of the five walking conditions).
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.
Time frame: Day 1 (during the single experimental session, assessed during each of the five walking conditions).
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.
Time frame: Day 1 (during the single experimental session, assessed during each of the five walking conditions).
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.
Time frame: Day 1 (during the single experimental session, assessed during each of the five walking conditions).
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.
Time frame: Day 1 (during the single experimental session, assessed during each of the five walking conditions).
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.
Time frame: Day 1 (during the single experimental session, assessed during each of the five walking conditions).
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.
Time frame: Day 1 (during the single experimental session, assessed during each of the five walking conditions).
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.
Time frame: Day 1 (immediately after each of the five walking conditions during the single experimental session).
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.
Time frame: Day 1 (immediately after each of the five walking conditions during the single experimental session).
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).
Time frame: Day 1 (at baseline, before the walking experiments).
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.
Time frame: Day 1 (at baseline, before the walking experiments).
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.
Time frame: Day 1 (immediately after each of the four VR walking conditions during the single experimental session).
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.
Time frame: Day 1 (immediately after each of the four VR walking conditions during the single experimental session).
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).
Time frame: Day 1 (before the VR walking conditions and immediately after completion of the final VR condition).
Not enrolling at this site.
Plan to share: 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.
Supporting information: Study protocol, Informed consent form
Time frame: Data will be available upon reasonable request following publication of the main study results.
Access criteria: Researchers should submit a scientifically justified request to the principal investigator, specifying the research question, requested data, and planned analyses. Requests will be reviewed by the study research team. Access will be subject to participant consent, applicable institutional and data protection requirements, and a data use agreement.
No publications or documents are linked to this record.
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