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

2 listopada 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

60

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Litwa
      • Vilnius, Litwa
        • Zakończony
        • Vilnius Gediminas Technical University
  • Słowenia
      • Izola, Słowenia, 6310
        • Rekrutacyjny
        • University of Primorska, Faculty of Health Sciences
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

50 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Podstawowa nauka
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Behawioralne: 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.

Behawioralne: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Gait Speed
Ramy czasowe: 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).

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Cadence
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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).

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Primorska

Współpracownicy

Vilnius Gediminas Technical University (VILNIUS TECH)

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

26 sierpnia 2026

Zakończenie podstawowe (Szacowany)

30 listopada 2026

Ukończenie studiów (Szacowany)

30 listopada 2026

Daty rejestracji na studia

Pierwszy przesłany

26 października 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

2 listopada 2026

Pierwszy wysłany (Rzeczywisty)

5 listopada 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

5 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

2 listopada 2026

Ostatnia weryfikacja

1 listopada 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • BIL-VILT-2026-01
  • 0120-160/2026-2711-3 (Inny numer grantu/finansowania: Republic of Slovenia National Medical Ethics Committee)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu 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.

Ramy czasowe udostępniania IPD

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

Kryteria dostępu do udostępniania 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.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • ICF

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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