The Application of Thermal Stimulation on Functional Recovery of Stroke Patients
調査の概要
状態
条件
詳細な説明
The thermal stimulation (TS) intervention uses the heat and cold apply alternately (~30minutes), and this kind temperature application is common in clinical neuromuscular or sports rehabilitation. Moreover, some studies have proved efficacy of the TS on stroke. However, the best parameters and application on different-stage stroke groups have not been clearly explored. Moreover, in order to discover the TS intervention influences on neuroplasticity, the brain images and the brain mapping are taken in the group A (explained in the below). In addition, the kinematic data was also collected in group A. However, the above-mentioned three examination are optional. Finally, functional recovery measurements (clinical scales) are measured in the three groups.
There are three groups (90 participants in each group) and their respective TS intervention design. In other word, three sub-studies (A, B, C) are under this project. Group A recruited 90 acute stroke (~ 30 days) and the independent variable is temperature of TS intervention. Group B is with sub-acute stroke (3-12 months), undergoing different frequency of TS intervention. Group C targets on participants with chronic stroke (> 1 y/o) and this variation in TS is intensity of TS application (30 mins vs 60 mins/each session).
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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Kaohsiung city、台湾、807
- Kaohsiung Medical University
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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:
- first-ever ischemic stroke;
- no severe cognitive impairments and able to follow instructions;
- sit on a chair for more than 30 minutes independently.
Exclusion Criteria:
- musculoskeletal or cardiac disorders that potentially interferes with experimental tests;
- diabetic or sensory impairment that attributable to peripheral vascular disease or neuropathy;
- speech disorder or global aphasia;
- skin problems at the sites of stimulation;
6.contraindications of heat or ice application.
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：階乗代入
- 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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実験的：Noxious TS in study A
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hot, cold alternately, noxious TS in study A
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アクティブコンパレータ：Innocuous TS
Innocuous TS in study A
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warm, cool alternately, Innocuious TS in study A
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実験的：High Frequency of Noxious TS
High Frequency of Noxious TS in study B
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High Frequency of Noxious TS in study B
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アクティブコンパレータ：Low Frequency of Noxious TS
Low Frequency of Noxious TS in study B
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Low Frequency of Noxious TS in study B
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実験的：High Intensity of Noxious TS
High Intensity of Noxious TS in study C
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High Intensity of Noxious TS in study C
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アクティブコンパレータ：Low Intensity of Noxious TS
Low Intensity of Noxious TS in study C
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Low Intensity of Noxious TS in study C
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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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Movement performance assessment
時間枠：baseline, half time-line of whole intervention period, post-intervention, 1 month follow-up, 6 month follow-up
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baseline, half time-line of whole intervention period, post-intervention, 1 month follow-up, 6 month follow-up
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Brain images
時間枠：immediate effects in 3 timeline
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immediate effects in 3 timeline
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Mapping of brain cortex
時間枠：immediate effect in four timeline
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immediate effect in four timeline
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Kinematics measure of upper extremity movement
時間枠：four timeline
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four timeline
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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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Quality of life
時間枠：baseline, post-intervention, 6 month follow-up
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baseline, post-intervention, 6 month follow-up
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協力者と研究者
捜査官
- 主任研究者：Jau-Hong Lin, Professor、Kaohsiung Medical University
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 (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。
Noxious TSの臨床試験
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Virginia Commonwealth UniversityNational Institute on Disability, Independent Living, and Rehabilitation Research; Administration...募集
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Columbia UniversityNational Institute of Mental Health (NIMH)完了