Encouragement-induced Movement Therapy in Daily Life (ISEAR)
Encouragement-induced Movement Therapy in Daily Life - a Randomized Controlled, Assessor-blinded Multi-center Trial in Stroke Patients With a Unilateral Hemiparesis, Using a Wrist-worn Tracking and Feedback Device
Stroke places a major burden on health care and society. It often leads to a hemiparesis. Intensive stroke rehabilitation speeds up recovery. In daily practice, the financial and/or human resources to provide this intensive rehabilitation are often lacking. Applying modern-day tracking and feedback technology to encourage a self-administered, context specific training is expected to offer significant potential to increase intensity of practice. Up until now, there has been no randomized trial examining the effect of such an intervention on daily arm usage.
The primary objective of this study is to determine the effect of wearing an activity tracking and multimodal feedback device for six weeks on self-reported daily life use of the paretic arm after stroke, when compared to control group stroke subjects wearing a hardware-wise identical sham device providing no feedback. The secondary aim is to examine compliance to use the device and the quantitative, qualitative and functional improvement of the paretic arm. It is hypothesized that participants in the experimental group show a higher change in self-reported daily life use of the paretic arm when compared to the control group both post intervention and at 6-week follow-up.
ISEAR is a multicenter, assessor-blinded randomized controlled trial of 62 subjects beyond the first 3 months poststroke.
調査の概要
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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Vitznau、スイス
- Cereneo, Center For Neurology and Rehabilitation
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Wald、スイス
- Zürcher RehaZentrum Wald
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Zürich、スイス
- University Hospital Zurich
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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:
- Above 18 years of age with unilateral stroke and residual hemiparesis leading to a decrease of arm function after completion of all inpatient rehabilitation (at least 90 days post stroke)
- Ability to lift arm against gravity (>30 degrees flexion or abduction)
- Ability to don/doff the devices on both wrists independently or with assistance of a caregiver
- Ability to give informed consent as documented by signature
Exclusion Criteria:
- Major untreated depression
- Severe cognitive impairment
- Suffering from comprehensive aphasia
- Severely impaired sensation (unable to feel a soft touch on the dorsal side of their paretic wrist with closed eyes)
- Other major comorbidities (e.g., cardiopulmonary disease, renal failure, hepatic dysfunction, orthopedic disorders, etc.)
- Expected hospitalization during study period
- Known intolerance to device material
- Known or suspected non-compliance, drug or alcohol abuse
- The investigator, his/her family members, employees, and other dependent persons
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：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：Monitoring and Feedback
Subjects will use two wrist-worn wearables over a period of 6 weeks.
Patients will receive multimodal (vibrotactile and visual) feedback.
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See arm/group description.
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プラセボコンパレーター：Monitoring
Study subjects will use identical devices over a period of 6 weeks.
Patients will *not* receive multimodal feedback.
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See arm/group description.
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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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Motor Activity Log - 14, Amount of Use sub scale
時間枠：Post-intervention (6 weeks)
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Self-reported amount of upper limb use in daily life
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Post-intervention (6 weeks)
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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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Fugl-Meyer Assessment, Upper Extremity sub scale
時間枠：Post-intervention (6 weeks)
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Upper limb motor function
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Post-intervention (6 weeks)
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Fugl-Meyer Assessment, Upper Extremity sub scale
時間枠：Follow-up (12 weeks)
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Upper limb motor function
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Follow-up (12 weeks)
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Action Research Arm Test
時間枠：Post-intervention (6 weeks)
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Upper limb capacity
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Post-intervention (6 weeks)
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Action Research Arm Test
時間枠：Follow-up (12 weeks)
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Upper limb capacity
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Follow-up (12 weeks)
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Modified Rankin Scale
時間枠：Post-intervention (6 weeks)
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Global Disability
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Post-intervention (6 weeks)
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Modified Rankin Scale
時間枠：Follow-up (12 weeks)
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Global Disability
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Follow-up (12 weeks)
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EuroQol five dimensions five levels questionnaire
時間枠：Post-intervention (6 weeks)
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Quality of Life
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Post-intervention (6 weeks)
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EuroQol five dimensions five levels questionnaire
時間枠：Follow-up (12 weeks)
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Quality of Life
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Follow-up (12 weeks)
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Motor Activity Log - 14, Quality of Movement sub scale
時間枠：Post-intervention (6 weeks)
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Self-reported quality of upper limb use in daily life
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Post-intervention (6 weeks)
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Motor Activity Log - 14, Quality of Movement sub scale
時間枠：Follow-up (12 weeks)
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Self-reported quality of upper limb use in daily life
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Follow-up (12 weeks)
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Motor Activity Log - 14, Amount of Use sub scale
時間枠：Follow-up (12 weeks)
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Self-reported amount of upper limb use in daily life
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Follow-up (12 weeks)
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
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Global Rating of Perceived Change
時間枠：Post-intervention (6 weeks)
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Post-intervention (6 weeks)
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Global Rating of Perceived Change
時間枠：Follow-up (12 weeks)
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Follow-up (12 weeks)
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Concomitant movement therapy
時間枠：Post-intervention (6 weeks)
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Time spend at Movement therapy (e.g., Physiotherapy, Occupational therapy)
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Post-intervention (6 weeks)
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Concomitant movement therapy
時間枠：Follow-up (12 weeks)
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Follow-up (12 weeks)
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Adverse Events
時間枠：Baseline (0 week)
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Safety
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Baseline (0 week)
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Adverse Events
時間枠：Post-intervention (6 weeks)
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Safety
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Post-intervention (6 weeks)
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Adverse Events
時間枠：Follow-up (12 weeks)
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Safety
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Follow-up (12 weeks)
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Andreas R Luft, Prof. MD、University of Zurich
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 (実際)
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 (実際)
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
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