Effects of Ecologically Valid VR Task-Oriented Exercises on Post-Stroke Motor and Cognitive Function (RECOVER)
Effectiveness of Virtual Reality-based Task-oriented Exercises in Ecologically Valid Environments on Motor and Cognitive Function in Individuals Post-stroke. A Randomized Controlled Trial
Why is this study being done?
After a stroke, many people have problems with movement, such as walking, balance, and using their arms and hands. They may also experience difficulties with thinking skills, including attention, memory, and problem-solving. These movement and thinking abilities work closely together during everyday activities, such as preparing a meal, shopping, or moving safely through the home.
Traditional rehabilitation often treats movement and thinking problems separately. However, difficulties with attention, planning, and decision-making can affect a person's ability to move safely and learn new motor skills. Because of this, rehabilitation approaches that train both movement and thinking skills at the same time may provide greater benefits.
Virtual reality (VR) technology can create realistic, interactive environments that allow people to practice everyday activities in a safe setting. However, there is limited research on VR programs that simultaneously challenge both movement and thinking skills, and little is known about whether any benefits last over time.
What is the purpose of this study?
The purpose of this study is to compare a virtual reality-based rehabilitation program that combines movement and cognitive training in realistic everyday environments with conventional occupational therapy. The study will evaluate whether the VR program leads to greater improvements in motor function and cognitive function after stroke and whether these improvements are maintained over the long term.
調査の概要
状態
条件
詳細な説明
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Valencia、スペイン
- IRENEA. Instituto de Rehabilitación Neurológica
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Diagnosis of stroke confirmed by computed tomography or magnetic resonance imaging
- Chronicity > six months
- Ausence of severe cognitive deficits (Mini-Mental State Examination > 23)
- Ability to stand safely and without assistance
- No or minimal muscle tone (Modified Ashworth Scale < 3).
Exclusion Criteria:
- Severe visual or hearing deficits
- Unilateral spatial neglect
- Ataxia
- Orthopedic abnormalities
- Lower limb pain syndrome or peripheral nerve injury affecting the lower limbs.
研究計画
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Control
Conventional occupational therapy
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Each session consists of three components.
The first component includes preparatory activities designed to improve function of the affected upper limb.
The second component focuses on fine motor skill training through exercises targeting reaching, grasping, object manipulation, and movements across the body's midline.
The third component addresses individual motor and cognitive impairments through the practice of Basic Activities of Daily Living and Instrumental Activities of Daily Living, as well as structured problem-solving tasks related to everyday situations.
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実験的：Experimental
Combined virtual reality-based exercises and conventional occupational therapy
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Each session consists of three components.
The first component includes preparatory activities designed to improve function of the affected upper limb.
The second component focuses on fine motor skill training through exercises targeting reaching, grasping, object manipulation, and movements across the body's midline.
The third component addresses individual motor and cognitive impairments through the practice of Basic Activities of Daily Living and Instrumental Activities of Daily Living, as well as structured problem-solving tasks related to everyday situations.
The intervention consists of interactive video games to train activities of daily living in a customizable digital version of the participant's own kitchen. During training, participants control a sex-matched avatar that reflects their real-time movements. They interact with common kitchen objects while practicing tasks that target both motor abilities, such as balance, posture, and hand-eye coordination, and cognitive abilities, such as attention, memory, planning, and problem-solving. The system can use photographs of the participant's home kitchen to create a familiar and realistic virtual environment. This approach is intended to support the transfer of skills practiced during therapy to the participant's everyday activities at home. |
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 |
|---|---|---|
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Change in Berg Balance Scale
時間枠：From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention
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Change in the balance of the Berg Balance Scale from baseline to the end of the intervention and from the end of the intervention to follow-up. The Berg Balance Scale is a clinical tool that assesses a person's static and dynamic balance to determine their risk of falling. It is primarily used for older adults and patients with neurological or motor disorders. Score range 0-54 |
From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Functional Reaches Test
時間枠：From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention
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Change in the Functional Reaches Test from baseline to the end of the intervention and from the end of the intervention to follow-up. The Functional Reach Test measures a person's dynamic balance and stability limits while standing. It specifically assesses the maximum distance a patient can reach forward with an outstretched arm without taking a step or losing balance. Score range: NA |
From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention
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Change in Four Square Step Test
時間枠：From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention
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Change in the seconds of the Four Square Step Test from baseline to the end of the intervention and from the end of the intervention to follow-up.
The Four Square Step Test (FSST) is a performance-based assessment that evaluates dynamic balance, mobility, and the ability to change direction while walking.
During the test, participants step as quickly as possible in a specific sequence through four squares formed by low obstacles on the floor, moving forward, backward, and sideways.
The test measures the time required to complete the sequence and assesses balance control, coordination, agility, and the ability to safely negotiate obstacles during movement.
It is commonly used to identify mobility limitations and fall risk in individuals with neurological conditions, including stroke.
Score range: NA
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From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention
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Change in the 10-meters walk Test
時間枠：From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention
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Change in the 10-meters walk Test from baseline to the end of the intervention and from the end of the intervention to follow-up.
The 10-Meter Walk Test measures walking speed in meters per second (m/s).
It assesses functional mobility, independence, and frailty by recording the time it takes a patient to walk a short distance (typically the central 6- or 8-meter section of a 10- to 14-meter corridor).
Score range: NA
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From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention
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Change in the Activities-Specific Balance Confidence Scale
時間枠：From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention
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Change in the Activities-Specific Balance Confidence Scale from baseline to the end of the intervention and from the end of the intervention to follow-up.
The Activities-Specific Balance Confidence Scale is a questionnaire that assesses a person's confidence in maintaining balance and avoiding falls while performing 16 everyday activities.
Score range: 0-100.
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From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention
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Change in the Conner's Continuous Performance Test III
時間枠：From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention
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Change in the Conner's Continuous Performance Test III from baseline to the end of the intervention and from the end of the intervention to follow-up.
The Conners Continuous Performance Test is a computerized neuropsychological test that assesses sustained attention, vigilance, inhibitory control (impulsivity), and selective attention.
Score range: NA
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From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention
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Changes in the Spatial Span Test
時間枠：From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention
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Changes in the Spatial Span Test from baseline to the end of the intervention and from the end of the intervention to follow-up.
The Spatial Span Test measures visuospatial short-term memory and visual working memory capacity.
Score ranges: 0-9
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From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention
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Changes in the Trail Making Test
時間枠：From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention
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Changes in the seconds of part A and part B for Trail Making Test from baseline to the end of the intervention and from the end of the intervention to follow-up.
The Trail Making Test is designed to assess attention, processing speed, cognitive flexibility, and executive functions.
It consists of two parts (A and B) in which the patient must connect numbered or lettered circles as quickly as posible.
Score Range: 0-300 s
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From baseline to the end of the intervention and from the end of the intervention to one-month after the intervention
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Roberto Llorens, PhD、Universitat Politecnica de Valencia
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- P0524032022
- PID2022-141498OA-I00 (その他の助成金/資金番号：Ministerio de Ciencia e Innovación)
- RTC2019-006933-7 (その他の助成金/資金番号：Ministerio de Ciencia e Innovación)
- INREIA/2024/73 (その他の助成金/資金番号：Conselleria d'Innovació, Indústria, Comerç i Turisme)
- CIDEXG/2022/15 (その他の助成金/資金番号：Conselleria d'Innovació, Universitats, Ciència i Societat Digital of Generalitat Valenciana)
- 60/2023 (その他の助成金/資金番号：Fundació la Marató de la TV3)
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?
IPD プランの説明
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
米国FDA規制機器製品の研究
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