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全方位仮想現実とトレッドミルを使用した慢性脳卒中トレーニング (PROVE)

2026年10月2日 更新者：Adria Quigley、Nova Scotia Health Authority

PROVE-VR: 慢性脳卒中生存者向けの全方位仮想現実とトレッドミル トレーニングを使用したパイロットランダム化試験

The primary objective of this pilot randomized controlled trial (RCT) is to test the feasibility (consent rate, retention rate, participant burden, adherence, technical issues, safety) and usability (system usability scale, SUS) of Omnidirectional treadmill Virtual Reality training (omni-VR) among chronic stroke survivors. Our secondary objective is to (1) estimate the extent to which cognition, brain activation during a dual task activity, walking ability, and dynamic balance change after 3 months of training among intervention participants (omni-VR) and traditional exercise controls, and (2) estimate the extent to which health-related quality of life and motivation co-evolve with our secondary outcomes.

Researchers will compare the intervention group and control group to evaluate the impact of omni-VR on cognition and physical function among stroke survivors.

Participants will:

  • undergo a 45-minute training session 3 times per week for 12 weeks
  • intervention group: omni-VR
  • control group: traditional exercise program (strengthening and walking activities)

調査の概要

状態

募集

条件

介入・治療

詳細な説明

Mounting data indicates that cognition plays a role in complex walking and balance. However, conventional intervention methods lack a sufficient incentive to encourage participants to adhere to the treatment. Further, it is difficult to provide a substantial amount of treatment to induce cortical reorganization.

Virtual reality or VR (a computer-generated simulation of 3-dimensional virtual environments that reacts in real time to the user's actions) has been introduced to neurorehabilitation to promote improvements in walking ability, balance, and cognition. It has also been demonstrated to be effective in improving motivation among stroke survivors and augmenting neuroplasticity.

Omnidirectional treadmill technology can be integrated with VR to allow for fully immersive rehabilitation. This novel and innovative technology mimics real-world environments and maximizes challenging cognitive and physical dual-tasking and balance activities while maintaining patient safety. However, no randomized trials have evaluated the impact of omnidirectional treadmill VR (Omni-VR) on cognitive and physical function among stroke survivors.

Therefore, our study aims to test the feasibility and usability of the Omni-VR. This pilot randomized control trial will also be the first study to test the feasibility and effect of a fully-immersive active omni-VR system among chronic stroke survivors

研究の種類

介入

入学 (推定)

30

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

  • カナダ
    • Nova Scotia
      • Halifax、Nova Scotia、カナダ、B3H 4K4
        • 募集
        • Nova Scotia Rehabilitation & Arthritis Centre
        • コンタクト：

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

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria

  • Age ≥ 18
  • Stroke ≥ 6 months ago (confirmed with chart review)
  • Living within 50 km of Halifax, Nova Scotia
  • Functional Ambulation Category of 3 or greater on a scale of 0-5, to ensure the participant is able to walk with supervision or independently. This criterion was selected to ensure participants could safely participate in the intervention.
  • Ability to participate in low-moderate intensity aerobic or strengthening exercise for ≥ 15 minutes to ensure participants can tolerate intervention sessions of 30-45 minutes, with activity breaks, in keeping with previous stroke rehabilitation studies.
  • No uncorrected visual deficits or spatial neglect
  • No cardiovascular, orthopedic, or neurological diseases other than stroke impacting walking or balance
  • Can follow simple instructions
  • Score of < 27 on the adapted Motion Sickness Susceptibility Scale-Short based on established normative values indicating more than moderate susceptibility to motion sickness.

Exclusion Criteria:

  • Unstable serious medical condition
  • Resting blood pressure >180/100mmHg
  • History of abnormal untreated heart rhythm
  • Pregnancy
  • Condition limiting ability to complete or tolerate the exercises without major program modifications (e.g., chronic low back pain)
  • Serious comorbid condition that would affect participation in the intervention (e.g., active cancer, severe heart disease)
  • Severe loss of hearing or speech that would preclude VR use
  • Participant weight more than 264 lbs (weight limit for Virtualizer Elite 2 treadmill)
  • Participating in another formal lower limb exercise program > 1 day per week
  • History of QT prolongation or using potential QT prolonging drugs

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：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
実験的：Omni-VR group

20 participants will undergo 45-minute training sessions 3 times per week for 12 weeks using omnidirectional virtual reality and treadmill training.
デバイス：Omnidirectional Virtual Reality and Treadmill Training

Omni-VR forest scenario developed by our team involving real-life dual task walking and dynamic balance activities (ie. stepping over obstacles, and managing distractions) will be used for treatment group.
アクティブコンパレータ：Control group

10 participants will undergo 45-minute traditional physiotherapy training sessions including lower limb strengthening and unidirectional treadmill training 3 times per week for 12 weeks.
行動：Traditional Exercise

A traditional exercise program including strengthening and unidirectional treadmill activities for the same duration will be completed in control group.

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
Consent rate
時間枠：Baseline

Consent rate is the percentage of eligible individuals who participate. The investigators expect a consent rate of at least 40%.
Baseline
Retention rate
時間枠：12 weeks (study completion)

Retention rate is the percentage of participants who complete the 12-week intervention. The investigators expect a retention rate of 80% for the intervention group.
12 weeks (study completion)
Usability of the Omnidirectional Treadmill and Virtual Reality Game
時間枠：12 weeks (study completion)

Usability will be assessed by System Usability Scale (SUS) out of 100 points. The investigators expect a SUS score of 71 or higher among all participants.
12 weeks (study completion)
Participant burden
時間枠：Baseline and 12 weeks (study completion)

Participant burden will be measured by the percentage of participants finishing assessments in 100 minutes or less. The investigators anticipate at least 85% of participants completing assessments within the time limit.
Baseline and 12 weeks (study completion)
Adherence
時間枠：12 weeks (study completion)

Adherence will be measured by the exercise session attendance. The investigators expect the treatment group to attend 70% or more of the sessions.
12 weeks (study completion)
Equipment downtime
時間枠：12 weeks (study completion)

The investigators will record any treadmill downtime due to VR technical issues. The targets are zero significant downtime in 85% of sessions.
12 weeks (study completion)
Equipment safety
時間枠：12 weeks (study completion)

The investigators will record any serious adverse events related to the study. The target is no serious adverse events related to the study
12 weeks (study completion)

二次結果の測定

結果測定
メジャーの説明
時間枠
Cognitive function
時間枠：Baseline and 12 weeks (study completion)

The investigators will use the Computerized MoCA [Montreal Cognitive Assessment] Duo to evaluate participants' cognitive function.
Baseline and 12 weeks (study completion)
Executive Function
時間枠：Baseline and 12 weeks (study completion)

The investigators will use the Dimensional Change Card Sort to evaluate participants' executive function.
Baseline and 12 weeks (study completion)
Working memory
時間枠：Baseline and 12 weeks (study completion)

The investigators will use the List Sorting Working Memory Test to evaluate participants' working memory.
Baseline and 12 weeks (study completion)
Brain activation in prefrontal and premotor cortices
時間枠：Baseline and 12 weeks (study completion)

Brain activation using fNIRS [Functional near-infrared spectroscopy] in the prefrontal and premotor regions of interest during a single task (steady-state omnidirectional treadmill walking) and two cognitive-physical dual-task activities (simple dual-task: steady-state omnidirectional treadmill walking while repeating the same word and complex dual-task: steady-state omnidirectional treadmill walking while performing a verbal fluency test)
Baseline and 12 weeks (study completion)
Walking Speed
時間枠：Baseline and 12 weeks (study completion)

Walking speed using VIVE trackers on omnidirectional treadmill and overground
Baseline and 12 weeks (study completion)
Step cadence
時間枠：Baseline and 12 weeks (study completion)

The investigators will evaluate step cadence using the VIVE trackers.
Baseline and 12 weeks (study completion)
Step width
時間枠：Baseline and 12 weeks (study completion)

The investigators will evaluate step width using the VIVE trackers.
Baseline and 12 weeks (study completion)
Step length
時間枠：Baseline and 12 weeks (study completion)

The investigators will evaluate step length using the VIVE trackers.
Baseline and 12 weeks (study completion)
Dynamic balance
時間枠：Baseline and 12 weeks (study completion)

The investigators will measure the static sway with feet together using omni-VR system and use MINI-BESTest to measure the dynamic balance.
Baseline and 12 weeks (study completion)

その他の成果指標

結果測定
メジャーの説明
時間枠
Motivation of participant
時間枠：12 weeks (study completion)

The investigators will measure motivation by intrinsic motivation inventory. Higher scores indicate better results.
12 weeks (study completion)
Health-related quality of life of participant
時間枠：Baseline and 12 weeks (study completion)

The investigators will measure health-related quality of life by the Stroke Impact Scale-3.0. Higher scores indicate better results.
Baseline and 12 weeks (study completion)

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。

スポンサー

Nova Scotia Health Authority

協力者

Brain Canada

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)

2025年4月28日

一次修了 (推定)

2027年8月6日

研究の完了 (推定)

2027年9月6日

試験登録日

最初に提出

2024年6月20日

QC基準を満たした最初の提出物

2024年7月3日

最初の投稿 (実際)

2024年7月10日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月6日

QC基準を満たした最後の更新が送信されました

2026年10月2日

最終確認日

2026年10月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • PROVE_stroke

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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