Effects of Home-based vs. Clinic-based Rehabilitation on Sensorimotor, Cognition, Daily Function, and Participation
2017年5月17日 更新者：Chang Gung Memorial Hospital
Effects of Home-based vs. Clinic-based Rehabilitation on Sensorimotor, Cognition, Daily Function, and Participation: Bilateral Training With and Without Mirror Feedback Program
The purpose of this study was to compare the treatment effects of home-based or clinic-based bilateral training with and without mirror feedback programon on physiological markers, sensorimotor, cognition, daily functions, and participation among patients with chronic stroke.
調査の概要
研究の種類
介入
入学 (実際)
24
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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Kaohsiung County、台湾
- Chang Gung Memorial Hospital
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Taoyuan County、台湾
- Chang Gung Memorial Hospital
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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～80年 (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:
- The most recent stroke was between 1 month and 5 years
- No serious cognitive impairment (MMSE≥21)
- FMA score =18-62
- No serious muscle spasticity in shoulder, elbow, wrist and finger (MAS≤3)
- Modified rankin Scale=2 to 4
Exclusion Criteria:
- Aphasia that might interfere with understanding instructions
- Stroke in areas other than the brain and brainstem, such as the cerebellum
- other neurological disease, such as dementia
- Muscle and joint have serious pain and inflammatory swelling in affected side.
- Cannot control hypertension, heart disease and serious throbosis
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：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- 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：Home-based
Participants in home-based training graoup will receive 1.5 hours/ day, 3 days a week, for 4 contious weeks at home. Participants will receive 2 training stages, including bilateral training with mirror feedback for 30-45 minutes and functional training for 45-60 minutes. Each training stage hase to include above 2 activities.After the end of the home-based training, a four-week wash-out period followed. Then, patients will receive the clinic-based training for 4 continuous weeks. Before and after the treatment, a total of 4 evaluations were conducted, including clinical assessments and blood test (each 9c.c.). One month after the end of the course of treatment will be assessed. |
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アクティブコンパレータ：Clinic-based
Participants in clinic-based training graoup will receive 1.5 hours/ day, 3 days a week, for 4 contious weeks at home. Participants will receive 2 training stages, including bilateral training with mirror feedback for 30-45 minutes and functional training for 45-60 minutes. Each training stage hase to include above 2 activities.After the end of the clinic-based training, a four-week wash-out period followed. Then, patients will receive the home-based training for 4 continuous weeks. Before and after the treatment, a total of 4 evaluations were conducted, including clinical assessments and blood test (each 9c.c.). One month after the end of the course of treatment will be assessed. |
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 |
時間枠 |
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Fugl-Myer Assessment, FMA
時間枠：Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
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Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
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Mini-Mental State Exam, MMSE
時間枠：Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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pinch and grasp dynamometer
時間枠：Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
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Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
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Modified Ashworth Scale, MAS
時間枠：Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
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Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
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Revised Nottingham Sensory Assessment
時間枠：Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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10-Meter Walking Test, 10MWT
時間枠：Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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Box and Block Test, BBT
時間枠：Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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Wolf Motor Function Test, WMFT
時間枠：Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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Chedoke Arm and Hand Activity Inventory
時間枠：Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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Canadian Occupational Performance Measure, COPM
時間枠：Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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Nottingham Extended Activities of Daily Living, NEADL
時間枠：Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
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Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
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ABILHAND Questionnaire
時間枠：Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
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Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
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Motor Activity Log, MAL
時間枠：Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
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Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
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Actigraphy
時間枠：Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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Stroke Impact Scale, SIS
時間枠：Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
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Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
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The World Health Organization Quality of Life -Brief version, WHOQOL-BRE
時間枠：Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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Medical Research Council scale,MRC
時間枠：Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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6 minute walk test
時間枠：Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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The Euroqol Quality of Life Scale
時間枠：Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
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Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
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Lawton-Brody IADL Scale
時間枠：Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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Pittsburg Sleep Quality Index
時間枠：Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
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Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
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二次結果の測定
結果測定 |
時間枠 |
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Montreal Cognitive Assessment, MoCA
時間枠：Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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Minnesota Rate of Manipulation Test during dual Task
時間枠：Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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Stroop Test
時間枠：Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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Movement Imagery Questionnaire- Revised, Second Edition, MIQ-RS
時間枠：Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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Kinesthetic and Visual Imagery Questionnaire-10, KVIQ-10
時間枠：Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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Modified Rankin Scale, mRS
時間枠：baseline
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baseline
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30 second sit-to-stand test
時間枠：Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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Timed up and go test
時間枠：Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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The stroke self-efficacy questionnaire
時間枠：Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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BDI-II，Beck Depression Inventory II
時間枠：Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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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。
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。
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
2014年9月1日
一次修了 (実際)
2017年4月12日
研究の完了 (実際)
2017年4月12日
試験登録日
最初に提出
2015年1月14日
QC基準を満たした最初の提出物
2015年2月10日
最初の投稿 (見積もり)
2015年2月18日
学習記録の更新
投稿された最後の更新 (実際)
2017年5月19日
QC基準を満たした最後の更新が送信されました
2017年5月17日
最終確認日
2016年11月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 103-3962A3
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。