IVR ON UPPER-LIMB REHABILITATION IN STROKE PATIENTS: A CLINICAL TRIAL (REVICTUS)
Impact of Immersive Virtual Reality in the Rehabilitation in the Acute Phase of Stroke: a Clinical Study and Correlation With Blood Biomarkers and Polymorphisms Related to Neuroplasticity
調査の概要
詳細な説明
The study will be conducted as a single-center, prospective, randomized, controlled, open-label clinical trial with blinded endpoint assessment. It aims to evaluate the benefits of neurorehabilitation combining conventional rehabilitation (CR) and immersive virtual reality (IVR) on patients' motor function and functional prognosis, as well as on the expression of blood biomarkers of neuroplasticity and the influence of specific genetic polymorphisms on rehabilitation response.
2. Study population
All patients meeting the following criteria will be included:
Inclusion criteria Diagnosis of ischemic stroke or intracerebral hemorrhage. Age > 18 years. < 7 days between stroke onset and inclusion in the study. Impairment of mobility in the right or left upper limb due to stroke. After hospital discharge, patients continue an intensive conventional rehabilitation (ICR) program at their referral rehabilitation center (MUTUAM).
Ability to understand and sign the study informed consent form (ICF) and the IDIBGI Biobank informed consent form.
Patients eligible for participation in the study will be those admitted to the Stroke Unit of Dr. Josep Trueta University Hospital (HUJT) with a diagnosis of ischemic stroke or intracerebral hemorrhage. Following clinical stabilization, and always within the first seven days after stroke onset, inclusion and exclusion criteria will be reviewed. Patients and their relatives will be informed about the study and will sign the informed consent forms (study and biobank). Patients will then be randomly assigned to one of the two study groups in a 1:1 ratio using a web-based platform and will be assigned an identification number for pseudonymization purposes.
The study groups will be:
Control group (CR): patients who will receive conventional rehabilitation (CR) in our hospital followed by an intensive conventional rehabilitation (ICR) program at the rehabilitation center.
Intervention group (CR+IVR): patients who will receive, in addition to CR, rehabilitation using the immersive virtual reality (IVR) system in our hospital, followed by the same ICR program as the control group together with IVR therapy at the rehabilitation center.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Yolanda Silva, MD PhD
- 電話番号：34972940262
- メール：ysilva.girona.ics@gencat.cat
研究場所
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Girona、スペイン
- 募集
- Hospital Dr Josep Trueta
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コンタクト：
- Yolanda Silva, MD PhD
- 電話番号：34972940262
- メール：neurologia.girona.ics@gencat.cat
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副調査官：
- Mikel Terceño, MD PhD
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副調査官：
- Elisvan Rufino
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副調査官：
- Nuria Bas
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副調査官：
- Imma Boada
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副調査官：
- Elisabet Ortiz
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副調査官：
- Carme Gubern
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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 ischemic stroke or intracerebral hemorrhage. Age > 18 years. < 7 days between stroke onset and inclusion in the study. Impairment of mobility in the right or left upper limb due to stroke. After hospital discharge, patients continue an intensive conventional rehabilitation (ICR) program at their referral rehabilitation center (MUTUAM).
Ability to understand and sign the study informed consent form (ICF) and the IDIBGI Biobank informed consent form.
-
Exclusion Criteria:
Previous upper limb disability (neurological or non-neurological cause). Previous dementia or any disease with a life expectancy of less than 1 year. Language comprehension difficulties. Difficulty remembering exercise instructions. History of photosensitive epilepsy.
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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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：Control Group
Control group (CR): patients who will receive conventional rehabilitation (CR) in our hospital followed by an intensive conventional rehabilitation (ICR) program at the rehabilitation center.
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アクティブコンパレータ：IVR group
Intervention group (CR+IVR): patients who will receive, in addition to CR, rehabilitation using the immersive virtual reality (IVR) system in our hospital, followed by the same ICR program as the control group together with IVR therapy at the rehabilitation center.
|
patients who will receive, in addition to CR, rehabilitation using the immersive virtual reality (IVR) system in our hospital, followed by the same ICR program as the control group together with IVR therapy at the rehabilitation center.
他の名前：
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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 |
|---|---|---|
|
Motor Function
時間枠：at 3 and 12 months
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NIHSS assessment of arm function
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at 3 and 12 months
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Quality of life of patients
時間枠：3 and 12 months
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ECVI-38
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3 and 12 months
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Functional outcome
時間枠：3 and 12 months
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modified Rankin scale
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3 and 12 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
FAC
時間枠：3 and 12 months
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Assessment of FAC
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3 and 12 months
|
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Fugl-Meyer
時間枠：3 and 12 months
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Fugl-Meyer Assessment
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3 and 12 months
|
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BBT
時間枠：3 and 12 months
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Assessment of BBT (Box and Block Test)
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3 and 12 months
|
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9HPT
時間枠：3 and 12 months
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Assessment of 9HPT (Nine-Hole Peg Test)
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3 and 12 months
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Safety measure
時間枠：3 months
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Adverse events
|
3 months
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協力者と研究者
出版物と役立つリンク
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 (推定)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。