Robotic Therapy and Transcranial Direct Current Stimulation in Patients With Stroke (ROTS)
調査の概要
状態
条件
詳細な説明
Our main goal is to confirm the safety of robotic therapy associated with active tDCS and conventional therapy, compared to robotic therapy associated with sham tDCS and to conventional therapy, and to conventional therapy alone, for upper limb rehabilitation in an early phase (3-9 weeks) after stroke. Patients will be randomized to receive one of these three treatments, 3 times per week, for 6 weeks.
Data about eventual adverse effect will be collected in each session of treatment. The working hypothesis is that robotic therapy associated with active tDCS and conventional therapy will be as safe as robotic therapy associated with conventional therapy, and as conventional therapy alone.
We will aso preliminarily evaluate the efficacy of robotic therapy associated with active tDCS and conventional therapy, compared to robotic therapy associated with sham tDCS and to conventional therapy alone, in improvement of upper limb motor impairment.
Our secondary goals are: 1) To evaluate safety and upper limb motor impairments in patients submitted to each of the three interventions, 6 months after end of treatment; 2) To compare effects of the abovementioned interventions on disability, spasticity and quality of life, in patients at an early stage after stroke, immediately after treatment and 6 months later.
The working hypothesis is that the association of robotic therapy, tDCS and conventional therapy will lead to better outcomes than robotic therapy and conventional therapy, or conventional therapy alone.
Patients will be assessed before the first session and after the last session of treatment, as well as 6 months after the last session of treatment.
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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SP
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São Paulo、SP、ブラジル、05403900
- Hospital das Clínicas
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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
説明
Inclusion Criteria:
- Ischemic or hemorrhagic stroke onset 3 - 9 weeks before the recruiting, confirmed by computed tomography or magnetic resonance imaging.
- Moderate to severe motor impairment of an upper limb, defined as a score between 7 - 42 on the Upper Limb Subscale of Fugl Meyer Assessment of Sensorimotor Recovery after stroke.
- Ability to provide written informed consent (patient ou legal representative)
- Ability to comply with the schedule of interventions and evaluations in the protocol.
Exclusion Criteria:
- Severe spasticity at the paretic elbow, wrist or fingers, defined as a score of > 3 on the Modified Ashworth Spasticity Scale.
- Upper limb plegia
- Uncontrolled medical problems such as end-stage cancer or renal disease
- Pregnancy
- Seizures, except for a single seizure during the first week post stroke
- Pacemakers
- Other neurological disorders such as Parkinson's disease
- Psychiatric illness including severe depression
- Aphasia ou severe cognitive deficits that compromise comprehension of the experimental protocol or ability to provide consent.
- Hemineglect
- Drugs that interfere on cortical excitability, except for antidepressants
- Cerebellar lesions
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：トリプル
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：Active tDCS + robotic therapy + physical therapy
Active tDCS (transcranial direct current stimulation) will be applied prior to the robotic training. After robot training, the patient will receive physical therapy for 40 minutes. Number of treatment sessions: 18 (3 times a week, for 6 weeks). |
ロボット療法 (MIT - マヌス、インタラクティブ モーション テクノロジーズ) は、麻痺した上肢に 40 分間投与されます。
Active tDCS will be applied with the cathode positioned over the ipsilesional primary motor cortex and the anode over the contralateral supraorbital region for 20 minutes (1mA).
Physical therapy will be administered for 40 minutes.
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アクティブコンパレータ：sham tDCS + robotic therapy + physical therapy
Sham tDCS (transcranial direct current stimulation) will be applied prior to robotic training. After robot training, the patient will receive physical therapy for 40 minutes. Number of treatment sessions: 18 (3 times a week, for 6 weeks). |
ロボット療法 (MIT - マヌス、インタラクティブ モーション テクノロジーズ) は、麻痺した上肢に 40 分間投与されます。
Physical therapy will be administered for 40 minutes.
In sham tDCS, no current will be delivered through the tDCS device.
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実験的：sham tDCS + physical therapy + occupational therapy
Sham tDCS (transcranial direct current stimulation) will be applied prior to conventional therapy (40 minutes of physical therapy and 40 minutes of occupational therapy) Number of treatment sessions: 18 (3 times a week, for 6 weeks).
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Physical therapy will be administered for 40 minutes.
In sham tDCS, no current will be delivered through the tDCS device.
Occupational therapy will be administered for 40 minutes.
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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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Change in Upper Extremity Fugl Meyer Assessment
時間枠：6 weeks from baseline
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Change in Motor function subscale was assessed.
Scores range from 0 to 66. Lower scores indicate greater severity.
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6 weeks from baseline
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Percentage of Sessions With Adverse Events
時間枠：Post treatment (6 weeks from baseline).
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Post treatment (6 weeks from baseline).
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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 Modified Rankin Scale
時間枠：6 weeks from baseline
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Scores range from 0 to 6. Higher scores indicate greater severity.
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6 weeks from baseline
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Change in National Institutes of Health Stroke Scale
時間枠：6 weeks from baseline
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Scores range from 0 to 42.
Higher scores indicate greater severity.
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6 weeks from baseline
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Change in Stroke Impact Scale
時間枠：6 weeks from baseline
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Scores in each domain of the Stroke Impact Scale range from 0 to 100, with higher scores indicating a better quality of life.
The change was calculated as the value at the later time point minus the value at the earlier time point; so that, positive numbers represent increases and negative numbers represent decreases.
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6 weeks from baseline
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Number of Participants Who Presented Score on Modified Ashworth Scale >2
時間枠：6 weeks
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Scores range from 0 to 4, with 5 choices.
A score of 1 indicates no resistance, and 4 indicates rigidity.
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6 weeks
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Change in Motor Activity Log
時間枠：6 weeks from baseline
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Each domain contains taks scored on 0 to 5 ordinal scale.
Lower scores indicate greater severity.
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6 weeks from baseline
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Upper Extremity Fugl Meyer Assessment
時間枠：6 months follow-up
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Motor function subscale was assessed.
Scores range from 0 to 66. Lower scores indicate greater severity.
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6 months follow-up
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Number of Participants With Adverse Events
時間枠：6 months follow-up
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6 months follow-up
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Change in Fatigue Severity Scale
時間枠：6 weeks from baseline
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Fatigue Severity Scale is a 9 -item questionnaire. Each item scores on a 7-point scale. The total score range from 9 to 63 points. Higher scores indicate greater fatigue. |
6 weeks from baseline
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Change in Pittsburgh Sleep Quality Index
時間枠：6 weeks from baseline
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The global Pittsburgh Sleep Quality Index score is calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21. Lower scores denote a healthier sleep quality.
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6 weeks from baseline
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協力者と研究者
捜査官
- 主任研究者：Adriana B Conforto, MD Phd、University of Sao Paulo
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
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 (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。
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