Objective Assessment of Upper Extremity Functioning of Stroke Patients Before and After Rehabilitation (AssStrFunc)
調査の概要
詳細な説明
Background: Most stroke patients continue to suffer from upper extremity motor deficiencies even after prolonged and intense rehabilitation in hospital. Even though guidelines and other studies recommend to apply a rehabilitation programs as patient reception. As opposed to that there is a scarce evidence for the efficacy of the rehabilitation.
Objectives: To evaluate by objective measures the improvement in motor performance of the upper extremity of stroke patients in the sub acute period. Secondary objective is to describe the correlation between proximal and distal motor deficiencies of the upper extremity.
Hypothesis: Patients will show better hand performance at the end of hospitalization. Part of it can be attributed to the rehabilitation and part to a spontaneous recovery. Correlation will be found for proximal and distal upper extremity motor deficiencies.
Methods:
Trial began only after the IRB research approval. All treatment sessions will implemented by the physical and occupational staff of the hospital. Assessments for the measures will be carry out by a certified physical therapist which is coinvestigator. The coinvestigator collect the raw data for analysis in Excel and than in SPSS.
20 stroke patients who meet the inclusion criteria will participate in the study, after signing an informed consent.Patients will undergo the first assessment of all measures, e.g: motor abilities by Fugl-Meyer test, handwriting kinematic and kinetic measures and surface electromyography for measurement of muscle synergy.Patients will be treated by standard rehabilitation of physical and occupational therapy for a period of 3-4 weeks. Before discharge from hospital patients will undergo another assessment of all measures, in order to evaluate the progression in their upper limb motor abilities from reception. Part of the patients will be assessed again two to three weeks after discharge as follow up.
Outcome Measures: upper limb Fugl-Meyer assessment, handwriting Air-time, pressure and velocity, EMG (i.e., muscle onset, muscle amplitude, muscle co-activation ratio).
Statistical analysis: ANOVA analysis will be used to measure time effect. Correlation between measures will be measured by Pearson's correlation. Sample size (n=20) was calculated based on 5 points improvement in Fugl-Meyer test as minimal significant change with power of 0.8 and p-level under 0.05 for significance.
Key words: Stroke, Muscle synergy, Handwriting, Fugl-Meyer
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Haifa、イスラエル、31021
- Fliman Geriatric Rehabilitation Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- diagnosis of cerebral stroke with upper extremity hemiparesis
- Ability to understand simple orders
Exclusion Criteria:
- Other orthopedic pathology
- Apraxia
- Bilateral Paresis
- Other neurologic pathology
- sensory aphasia
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
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Stroke
Stroke patients at the subacute phase
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task-oriented therapy: physical and occupational therapy emphasizing integration of the patients needs, environment and context
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Healthy controls
healthy age-matched voluntiers
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no treatment
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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 |
|---|---|---|
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Fugl-Meyer Assessment.
時間枠：T1 at the beginning of the hospital stay and folloew up at T2 one month later.
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zero to 66 points scale, measuring the impairment level of the upper extremity.
Zero indicates a high level of impairment or minimum hand motor function, while 66 points indicates an increased motor function which is similar to normal upper extremity function.
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T1 at the beginning of the hospital stay and folloew up at T2 one month later.
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Muscle Onset Time.
時間枠：the study group was assessed T1 at the beginning of the hospital stay and follow up at T2 one month later. The control group assessed for the the time onset and compared to the study group at T1
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Assessed by surface electromyography device.
The time period it takes the muscle to be activated and contract from a voice prompting is measured.
Shorter time onset probably charcterized healthy people compared to patients after a stroke.
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the study group was assessed T1 at the beginning of the hospital stay and follow up at T2 one month later. The control group assessed for the the time onset and compared to the study group at T1
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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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Muscle Co-activation Index.
時間枠：T1 at the beginning of the hospital stay and folloew up at T2 one month later.
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Assessed by surface electromyography device.
Indicate for the level by which muscles contract at the same time and amplitude.
It will be calculated in percentage from 100%, as 100% indicate for complete co-activation between a pair of muscles.
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T1 at the beginning of the hospital stay and folloew up at T2 one month later.
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Handwriting Velocity
時間枠：T1 at the beginning of the hospital stay and follow up at T2 one month later.
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Assessed by electronic tablet with specific software called ComPET.
Patient make writing tasks.
The velocity of his writing is measured and pass from the tablet to the computer to be processed by the software.
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T1 at the beginning of the hospital stay and follow up at T2 one month later.
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% Maximum Voluntary Contraction.
時間枠：The outcome will be measured twice. First at the beginning of the hospital stay and again at the end of the hospital stay, that is 4 weeks on average.
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T1 at the beginning of the hospital stay and folloew up at T2 one month later.
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The outcome will be measured twice. First at the beginning of the hospital stay and again at the end of the hospital stay, that is 4 weeks on average.
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Handwriting Pressure.
時間枠：T1 at the beginning of the hospital stay and folloew up at T2 one mont...
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Assessed by electronic tablet with specific software called ComPET.
Patient make writing tasks, and the pressure exerted with the pen on the tablet is recorded.
The data from the tablet passed to the computer to be processed by the software.
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T1 at the beginning of the hospital stay and folloew up at T2 one mont...
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Handwriting Off-paper Time.
時間枠：T1 at the beginning of the hospital stay and folloew up at T2 one mont...
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Assessed by electronic tablet with specific software called ComPET.
Patient make writing tasks.
The time the pen is on air is measured.
The data from the tablet passed to the computer to be processed by the software.
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T1 at the beginning of the hospital stay and folloew up at T2 one mont...
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Emanuel Markovich, MD、Fliman Geriatric Rehabilitation Center
- スタディディレクター：Sharon Israely, MSc.、University of Haifa
- スタディチェア：Eli Carmeli, PhD.、University of Hifa
研究記録日
主要日程の研究
研究開始
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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。
strokeの臨床試験
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Centre Hospitalier Universitaire de NīmesSociété par Action Simplifiée AI-Stroke募集
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Assistance Publique - Hôpitaux de Paris完了