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Predicting Real World Physical Activity and Upper Limb Use After Stroke (REUSE)

2021年11月25日 更新者:University of Zurich

Profiling and Predicting the Natural Course of Real World Physical Activity and Upper Limb Use After Stroke

Poststroke recovery mainly takes place within the first weeks to months and about 95% of the patients reach their maximum recovery 3 months after stroke onset. Poststroke rehabilitation is initiated as early as possible and aims to reduce functional consequences of stroke, allowing patients to integrate into the community. However, up to 75% of the patients remain disabled in the long term. Strikingly, about 20 to 30% of the patients show functional decline (i.e., learned-nonuse) in the long term - most often after having finished their intensive rehabilitation period - and even stroke survivors who have little or no residual disability are less physically active when compared to their age-matched peers.

Poststroke outcomes can be well predicted early after stroke. However, the deficits early after stroke and the outcomes are measured by standardized clinical tests performed in the laboratory. The drawback of these tests is that they provide information about the best possible abilities of the patients, as they are encouraged by therapists in testing situations. This so called "capacity" does not necessarily reflect what patients do in daily life situations (i.e., "performance" or "real world use").

With the growing interest in the patients' performance, various assessments that objectively measure activities in daily life situations have been developed in the last few years. These devices capture movement in daily life situations in a sensitive and objective way. An additional benefit is that they are less hampered by floor or ceiling effects when compared to clinical laboratory measurements (i.e., clinimetrics). Nevertheless, outcome of real world performance is hardly ever used in clinical trials aiming to determine the effectiveness of stroke rehabilitation interventions. Actually, until today, the natural course of performance remains largely unknown, as are predictors for this course. It is also unknown to which extend patients' subjective reporting of performance matches objectively measured performance. Finally, although it is believed that there is a threshold for, for example, real life use of the paretic arm and further improvement, there is no evidence as to what this threshold is in terms of clinical laboratory measurements.

The present prospective longitudinal cohort study fills in the gap regarding knowledge about the profile and predictability of two performance outcomes during the first year poststroke: engagement in physical activities and the use of the paretic upper limb. In addition, it will provide insight in how physical activity engagement and upper limb use measured by daily life assessments relate to standard clinical laboratory assessments. This knowledge is a prerequisite for the identification of patients' phenotypes and a first essential step towards the development of tailored (i.e., precision medicine), innovative rehabilitation interventions which enhance performance in terms of physical activities or upper limb use in daily life. The ultimate goal is to reduce poststroke disability and associated costs.

RE-USE is a prospective longitudinal observational cohort study of 120 first-ever stroke patients, who will be assessed 3, 10, 28, 90 and 365 days after stroke onset, as well as at discharge of the rehabilitation center.

調査の概要

研究の種類

観察的

入学 (実際)

98

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。

研究場所

      • Zurich、スイス、8091
        • University Hospital Zurich

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

サンプリング方法

非確率サンプル

調査対象母集団

Admitted to hospital

説明

Inclusion Criteria:

  • First-ever ischemic or hemorrhagic stroke, confirmed by MRI-DWI and/or CT (recurrent strokes are allowed when already included in this study after a first-ever stroke)
  • Paresis or paralysis of the arm and/ or leg
  • Living independently before stroke (mRS >2)
  • Age 18 years or older
  • Written informed consent of the patient or its legal representative after participants' information

Exclusion Criteria:

  • Contra-indications on ethical grounds (vulnerable persons)
  • Neurological or other diseases affecting upper limb use and/ or physical activity before stroke
  • Known or suspected non-compliance, drug or alcohol abuse

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

コホートと介入

グループ/コホート
介入・治療
Assessment of real world performance
Patients will be assessed by using movement sensors and standard clinical assessments

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
Daily life assessment of physical activity engagement and upper limb use
時間枠:90 days after stroke onset
Real world performance, measured with movement sensors (number)
90 days after stroke onset

二次結果の測定

結果測定
メジャーの説明
時間枠
Neurological impairments
時間枠:3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
National Institutes of Health Stroke Scale (0-42 points, lower scores being better)
3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Upper limb motor function
時間枠:3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Fugl-Meyer Assessment (0-66 points, higher scores being better)
3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Motor function
時間枠:3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Motricity Index (0-200 points, higher scores being better)
3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Trunk ability
時間枠:3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Trunk Control Test (0-100 points, higher scores being better)
3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Sitting and standing balance
時間枠:10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Berg Balance Scale (0-56 points, higher scores being better)
10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Walking ability (independence)
時間枠:3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Functional Ambulation Categories (0-5 points, higher scores being better)
3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Gait speed and cadence (time)
時間枠:10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Ten-Meter Walk Test
10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Upper limb capacity
時間枠:10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Action Research Arm Test (0-56 points, higher scores being better)
10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Upper limb capacity dexterity
時間枠:10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Box and Block Test (number of blocks)
10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Global disability
時間枠:3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Modified Rankin Scale (0-6 points, lower scores being better)
3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Fatigue
時間枠:10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Fatigue Severity Scale (9-63 point, lower scores being better)
10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Cognition
時間枠:3 and 90 days after stroke onset
Montreal Cognitive Assessment(0-30 points, higher scores being better)
3 and 90 days after stroke onset
Neglect
時間枠:3 and 90 days after stroke onset
Apples Test (number)
3 and 90 days after stroke onset
Patient-reported physical activity
時間枠:90 and 365 days after stroke onset
International Physical Activity Questionnaire (3 levels higher levels are better)
90 and 365 days after stroke onset
Patient-reported daily life upper limb use
時間枠:10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Motor Activity Log - 14 item version (0-5 points, higher scores being better)
10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Patient-reported changes
時間枠:10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Global Rating of Perceived Changes (1-7 points, higher scores being better; 1-10 points, lower scores being better)
10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Concomitant movement therapy
時間枠:3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Intensity of therapy based on charts (minutes)
3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Serious Events and non-serious infections or cardiovascular events
時間枠:3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Serious Events (1. death; 2. life-threatening illness or injury; 3. in-patient or prolonged hospitalisation; 4. medical or surgical intervention to prevent life threatening illness; 5. led to fetal distress, death or a congenital abnormality or birth defect) and non-serious infections or cardiovascular events
3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Daily life assessment of physical activity engagement and upper limb use
時間枠:3, 10, 28 (expected rehabilitation discharge) and 365 days after stroke onset
Real world performance, measured with movement sensors (number)
3, 10, 28 (expected rehabilitation discharge) and 365 days after stroke onset
Levels of anxiety and depression
時間枠:10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Hospital Anxiety and Depression Scale (0-42 points, higher scores indicate greater levels of anxiety or depression)
10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Health care costs and loss of income
時間枠:365 days after stroke onset
Health care costs and loss of income in relation to the stroke (CHF)
365 days after stroke onset

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

捜査官

  • スタディチェア:Andreas R Luft, Prof. Dr.、University of Zurich, University Hospital Zurich

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

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)

2018年9月1日

一次修了 (実際)

2021年3月31日

研究の完了 (実際)

2021年3月31日

試験登録日

最初に提出

2018年4月16日

QC基準を満たした最初の提出物

2018年4月30日

最初の投稿 (実際)

2018年5月11日

学習記録の更新

投稿された最後の更新 (実際)

2021年11月29日

QC基準を満たした最後の更新が送信されました

2021年11月25日

最終確認日

2021年11月1日

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