Combined Repetitive Transcranial Magnetic Stimulation and Robot-Assisted Upper Arm Training in Subacute Stroke Patients
2019年3月14日 更新者：Yonsei University
Combined Repetitive Transcranial Magnetic Stimulation and Robot-Assisted Upper Arm Training in Subacute Stroke Patients : Randomized Controlled Trial
This study was designed to establish the clinical evidence for effect of Robot-Assisted upper arm training and Repetitive Transcranial Magnetic Stimulation on upper limb function of subacute stroke patients.
- Purpose : to elucidate the effect of Robot-Assisted upper arm training and Repetitive Transcranial Magnetic Stimulation on upper limb function of stroke patients compared to conventional occupational therapy
- Subjects : total 99 patients with stroke whose upper limb functions are impaired
- Intervention : 4 weeks of therapy (5 days per week)
- Studies : upper limb functional assessment (FMA, MFT, WMFT), computerized motion analysis
- Evaluation plan : 1) pre-intervention, 2) post-2 weeks of intervention, 3) post-4 weeks of intervention, 4) 4 weeks after end of intervention
調査の概要
研究の種類
介入
入学 (実際)
108
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。
研究場所
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Seoul、大韓民国、03722
- Department of Rehabilitation Medicine, Severance Hospital, Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine
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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
20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:
- Upper FMA 7-38
- Hemiplegic patients within 6months after stroke onset
- male or female, 20 years older
Exclusion Criteria:
- Patients with cognitive impairment who are unable to comply with protocol-required procedure
- Quadriplegic or double hemiplegic patients
- Patients with musculoskeletal disease, peripheral nerve disease in upper extremity
- Patients with lower motor neuron disease
- Patients who cannot perform rTMS
- Pregnant woman
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：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Robot and rTMS
Robot-Assisted upper arm training and Repetitive Transcranial Magnetic Stimulation group(intervention group 1)
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The Armeo, a robot with a spring mechanism allowing adjustable arm weight support, can generate assistive forces of up to 66N in flexion/extension and up to 30N for the arm and forearm respectively. This robot integrates seven angle sensors and one pressure sensor that allow direct interaction between the motion of the patient's arm and the associated therapy software. rTMS is a magnetic method used to stimulate small regions of the brain. The Robot and rTMS group will receive the robot-assisted upper arm training and rTMS for 5 times per week, for 4 weeks. And all patients of three groups will receive the additional conventional occupational therapy for 30 minutes daily 5 times per week, for 4 weeks.
他の名前：
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実験的：Robot
Robot-Assisted upper arm training group(intervention group2)
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The Armeo, a robot with a spring mechanism allowing adjustable arm weight support, can generate assistive forces of up to 66N in flexion/extension and up to 30N for the arm and forearm respectively.
This robot integrates seven angle sensors and one pressure sensor that allow direct interaction between the motion of the patient's arm and the associated therapy software.
The Robot group will receive the robot-assisted upper arm training for 30 minutes daily 5 times per week, for 4 weeks.
And all patients of three groups will receive the additional conventional occupational therapy for 30 minutes daily 5 times per week, for 4 weeks.
他の名前：
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アクティブコンパレータ：Conventional
Conventional training group(control group)
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The conventional group will receive occupational therapy for 30 minutes daily 5 times per week, for 4 weeks instead of Robot or rTMS.
And all patients of three groups will receive the additional conventional occupational therapy for 30 minutes daily 5 times per week, for 4 weeks.
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 |
|---|---|---|
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Fugl-Meyer Assessment (FMA)
時間枠：1 minute before the first intervention
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The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index.
It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
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1 minute before the first intervention
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Fugl-Meyer Assessment (FMA)
時間枠：2 weeks after the first intervention
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The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index.
It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
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2 weeks after the first intervention
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Fugl-Meyer Assessment (FMA)
時間枠：4 weeks after the first intervention
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The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index.
It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
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4 weeks after the first intervention
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Fugl-Meyer Assessment (FMA)
時間枠：4 weeks after the final intervention
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The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index.
It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
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4 weeks after the final 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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Wolf motor function test
時間枠：1 minute before the first intervention
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The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability examinable through the use of timed and functional tasks.
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1 minute before the first intervention
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Wolf motor function test
時間枠：2 weeks after the first intervention
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The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability examinable through the use of timed and functional tasks.
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2 weeks after the first intervention
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Wolf motor function test
時間枠：4 weeks after the first intervention
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The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability examinable through the use of timed and functional tasks.
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4 weeks after the first intervention
|
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Wolf motor function test
時間枠：4 weeks after the final intervention
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The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability examinable through the use of timed and functional tasks.
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4 weeks after the final intervention
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Manual Function test
時間枠：1 minute before the first intervention
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The Manual Function Test (MFT) was developed to evaluate unilateral manual performance in hemiparetic patients after stroke.
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1 minute before the first intervention
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Manual Function test
時間枠：2 weeks after the first intervention
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The Manual Function Test (MFT) was developed to evaluate unilateral manual performance in hemiparetic patients after stroke.
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2 weeks after the first intervention
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Manual Function test
時間枠：4 weeks after the first intervention
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The Manual Function Test (MFT) was developed to evaluate unilateral manual performance in hemiparetic patients after stroke.
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4 weeks after the first intervention
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Manual Function test
時間枠：4 weeks after the final intervention
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The Manual Function Test (MFT) was developed to evaluate unilateral manual performance in hemiparetic patients after stroke.
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4 weeks after the final intervention
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Kinematic data of computerized 3D motion analysis
時間枠：1 minute before the first intervention
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D motion analysis will be performed using a computerized motion analysis system (VICON MX-T10 System with 6 infrared cameras, Oxford Metrics Inc., Oxford, UK) to measure the kinematic data (angle of each joint) during the task of drinking from a cup
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1 minute before the first intervention
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Kinematic data of computerized 3D motion analysis
時間枠：2 weeks after the first intervention
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D motion analysis will be performed using a computerized motion analysis system (VICON MX-T10 System with 6 infrared cameras, Oxford Metrics Inc., Oxford, UK) to measure the kinematic data (angle of each joint) during the task of drinking from a cup
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2 weeks after the first intervention
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Kinematic data of computerized 3D motion analysis
時間枠：4 weeks after the first intervention
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D motion analysis will be performed using a computerized motion analysis system (VICON MX-T10 System with 6 infrared cameras, Oxford Metrics Inc., Oxford, UK) to measure the kinematic data (angle of each joint) during the task of drinking from a cup
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4 weeks after the first intervention
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Kinematic data of computerized 3D motion analysis
時間枠：4 weeks after the final intervention
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D motion analysis will be performed using a computerized motion analysis system (VICON MX-T10 System with 6 infrared cameras, Oxford Metrics Inc., Oxford, UK) to measure the kinematic data (angle of each joint) during the task of drinking from a cup
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4 weeks after the final intervention
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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)
2015年6月18日
一次修了 (実際)
2018年6月26日
研究の完了 (実際)
2018年6月26日
試験登録日
最初に提出
2017年1月30日
QC基準を満たした最初の提出物
2017年2月1日
最初の投稿 (見積もり)
2017年2月3日
学習記録の更新
投稿された最後の更新 (実際)
2019年3月18日
QC基準を満たした最後の更新が送信されました
2019年3月14日
最終確認日
2019年3月1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。