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

2026年11月2日 更新者: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.

調査の概要

研究の種類

介入

入学 (推定)

60

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

      • Izola、スロベニア、6310
        • 募集
        • University of Primorska, Faculty of Health Sciences
        • コンタクト:
      • Vilnius、リトアニア
        • 完了
        • Vilnius Gediminas Technical University

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

50年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:基礎科学
  • 割り当て:なし
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.

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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Gait Speed
時間枠: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).

二次結果の測定

結果測定
メジャーの説明
時間枠
Cadence
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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)
時間枠: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
時間枠: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
時間枠: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
時間枠: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).

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年8月26日

一次修了 (推定)

2026年11月30日

研究の完了 (推定)

2026年11月30日

試験登録日

最初に提出

2026年10月26日

QC基準を満たした最初の提出物

2026年11月2日

最初の投稿 (実際)

2026年11月5日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月5日

QC基準を満たした最後の更新が送信されました

2026年11月2日

最終確認日

2026年11月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • BIL-VILT-2026-01
  • 0120-160/2026-2711-3 (その他の助成金/資金番号:Republic of Slovenia National Medical Ethics Committee)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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.

IPD 共有時間枠

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

IPD 共有アクセス基準

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.

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • ICF

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米国FDA規制機器製品の研究

いいえ

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