Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

2 novembre 2026 aggiornato da: University of Primorska

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.

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Lituania
      • Vilnius, Lituania
        • Completato
        • Vilnius Gediminas Technical University
  • Slovenia
      • Izola, Slovenia, 6310
        • Reclutamento
        • University of Primorska, Faculty of Health Sciences
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

50 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

Knee Osteoarthritis (KOA) Group:

Inclusion criteria:

  • 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.

Exclusion criteria:

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;
  • 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:

Inclusion criteria:

  • Age 50 years or older.
  • No significant gait disturbances.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: VR and Non-VR Walking Conditions

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.
Comportamentale: Immersive Virtual Reality Walking Conditions

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.

Comportamentale: Non-VR 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Gait Speed
Lasso di tempo: Day 1 (during the single experimental session, assessed during each of the five walking conditions).

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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Cadence
Lasso di tempo: Day 1 (during the single experimental session, assessed during each of the five walking conditions).

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.
Day 1 (during the single experimental session, assessed during each of the five walking conditions).
Stride Length
Lasso di tempo: Day 1 (during the single experimental session, assessed during each of the five walking conditions).

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.
Day 1 (during the single experimental session, assessed during each of the five walking conditions).
Stride Time
Lasso di tempo: Day 1 (during the single experimental session, assessed during each of the five walking conditions).

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.
Day 1 (during the single experimental session, assessed during each of the five walking conditions).
Step Width
Lasso di tempo: Day 1 (during the single experimental session, assessed during each of the five walking conditions).

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.
Day 1 (during the single experimental session, assessed during each of the five walking conditions).
Stance Phase Duration
Lasso di tempo: Day 1 (during the single experimental session, assessed during each of the five walking conditions).

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.
Day 1 (during the single experimental session, assessed during each of the five walking conditions).
Swing Phase Duration
Lasso di tempo: Day 1 (during the single experimental session, assessed during each of the five walking conditions).

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.
Day 1 (during the single experimental session, assessed during each of the five walking conditions).
Double Support Duration
Lasso di tempo: Day 1 (during the single experimental session, assessed during each of the five walking conditions).

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.
Day 1 (during the single experimental session, assessed during each of the five walking conditions).
First Vertical Ground Reaction Force Peak
Lasso di tempo: Day 1 (during the single experimental session, assessed during each of the five walking conditions).

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.
Day 1 (during the single experimental session, assessed during each of the five walking conditions).
Second Vertical Ground Reaction Force Peak
Lasso di tempo: Day 1 (during the single experimental session, assessed during each of the five walking conditions).

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.
Day 1 (during the single experimental session, assessed during each of the five walking conditions).
Mid-Stance Minimum Vertical Ground Reaction Force
Lasso di tempo: Day 1 (during the single experimental session, assessed during each of the five walking conditions).

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.
Day 1 (during the single experimental session, assessed during each of the five walking conditions).
Hip Sagittal Range of Motion
Lasso di tempo: Day 1 (during the single experimental session, assessed during each of the five walking conditions).

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.
Day 1 (during the single experimental session, assessed during each of the five walking conditions).
Knee Sagittal Range of Motion
Lasso di tempo: Day 1 (during the single experimental session, assessed during each of the five walking conditions).

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.
Day 1 (during the single experimental session, assessed during each of the five walking conditions).
Ankle Sagittal Range of Motion
Lasso di tempo: Day 1 (during the single experimental session, assessed during each of the five walking conditions).

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.
Day 1 (during the single experimental session, assessed during each of the five walking conditions).
Step Time Variability
Lasso di tempo: Day 1 (during the single experimental session, assessed during each of the five walking conditions).

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.
Day 1 (during the single experimental session, assessed during each of the five walking conditions).
Stance Time Variability
Lasso di tempo: Day 1 (during the single experimental session, assessed during each of the five walking conditions).

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.
Day 1 (during the single experimental session, assessed during each of the five walking conditions).
Step Width Variability
Lasso di tempo: Day 1 (during the single experimental session, assessed during each of the five walking conditions).

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.
Day 1 (during the single experimental session, assessed during each of the five walking conditions).
Gait Symmetry Index
Lasso di tempo: Day 1 (during the single experimental session, assessed during each of the five walking conditions).

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.
Day 1 (during the single experimental session, assessed during each of the five walking conditions).
Pain Intensity
Lasso di tempo: Day 1 (immediately after each of the five walking conditions during the single experimental session).

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.
Day 1 (immediately after each of the five walking conditions during the single experimental session).
Perceived Fear and Safety During Walking
Lasso di tempo: Day 1 (immediately after each of the five walking conditions during the single experimental session).

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.
Day 1 (immediately after each of the five walking conditions during the single experimental session).
Kinesiophobia
Lasso di tempo: Day 1 (at baseline, before the walking experiments).

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).
Day 1 (at baseline, before the walking experiments).
Health-Related Quality of Life (SF-36)
Lasso di tempo: Day 1 (at baseline, before the walking experiments).

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.
Day 1 (at baseline, before the walking experiments).
Sense of Presence in Virtual Reality
Lasso di tempo: Day 1 (immediately after each of the four VR walking conditions during the single experimental session).

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.
Day 1 (immediately after each of the four VR walking conditions during the single experimental session).
Perceived Immersion in Virtual Reality
Lasso di tempo: Day 1 (immediately after each of the four VR walking conditions during the single experimental session).

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.
Day 1 (immediately after each of the four VR walking conditions during the single experimental session).
Virtual Reality Sickness Symptoms
Lasso di tempo: Day 1 (before the VR walking conditions and immediately after completion of the final VR condition).

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Primorska

Collaboratori

Vilnius Gediminas Technical University (VILNIUS TECH)

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

26 agosto 2026

Completamento primario (Stimato)

30 novembre 2026

Completamento dello studio (Stimato)

30 novembre 2026

Date di iscrizione allo studio

Primo inviato

26 ottobre 2026

Primo inviato che soddisfa i criteri di controllo qualità

2 novembre 2026

Primo Inserito (Effettivo)

5 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • BIL-VILT-2026-01
  • 0120-160/2026-2711-3 (Altro numero di sovvenzione/finanziamento: Republic of Slovenia National Medical Ethics Committee)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Periodo di condivisione IPD

Data will be available upon reasonable request following publication of the main study results.

Criteri di accesso alla condivisione IPD

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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • ICF

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Sottoscrivi