Therapeutic Effects of a New Upper Limb Robot Assisted Therapy Device for Persons After Stroke (ARTHE)
Active Smart Wearable Orthosis Using Painted EMG Electrodes for Home Based Therapy With Augmentative Feedback
調査の概要
詳細な説明
The number of physically weak individuals is increasing, resulting in a higher burden on health care and health care workers. The use of robot assisted therapy (RAT) might partly solve this problem. Rehabilitation progress highly depends on training intensity and training duration, favouring the use of RAT.
In this pilot study, the clinical effects of using a new upper arm RAT device for upper arm rehabilitation in patients with stroke is investigated. Myo-electrical signals will serve as input for the device, assisting the user in flexion and extension of the elbow. The device is coupled to a virtual environments, creating a stimulating therapy environment.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Lore Van de Perre, MSc
- 電話番号:+32 14 56 23 10
- メール:lore.van.de.perre@khk.be
研究場所
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-
Antwepen
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Geel、Antwepen、ベルギー、2440
- Thomas More Kempen
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コンタクト:
- Lore Van de Perre, MSc
- 電話番号:+32 14 56 23 10
- メール:lore.van.de.perre@khk.be
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コンタクト:
- Peter Karsmakers, PhD
- 電話番号:+32 14 56 23 10
- メール:peter.karsmakers@khk.be
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主任研究者:
- Lore Van de Perre, MSc
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副調査官:
- Roy Sevit, MSc
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副調査官:
- Koen Janssens, MSc
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副調査官:
- Peter Karsmakers, PhD
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副調査官:
- Louis Peeraer, Prof.PhD
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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:
- Patients with stroke, more than three months post onset
- No or moderate spasticity in the upper limb (maximum score of 3 on Modified Ashworth Scale)
- Observable voluntary muscle activity in biceps and triceps muscle of the affected upper limb (minimal score of 1 on the Medical research council score)
- Able to sit on a chair with adequate trunk stability
- Able to follow verbal instructions
- Able to communicate verbal information to the researchers
Exclusion Criteria:
- Patients who are medically unstable
- Cognitive disorders impeding the intervention
- Visual disorders impeding the intervention
- Subluxation of the shoulder joint
- Pusher syndrome
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:支持療法
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- 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 |
---|---|
実験的:Training with the device
Training with new upper limb robot assisted therapy device
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During 8 weeks, 3 times a week, 1 hour therapy sessions with the device
他の名前:
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介入なし:Control group
The control group is treated with conventional therapy.
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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 |
---|---|---|
Fugl-Meyer test upper limb section
時間枠:Change from baseline Fugl-Meyer test upper limb section at 8 weeks and 12 weeks
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Stroke specific, performance based impairment index.
Applied to determine disease severity and describe motor recovery.
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Change from baseline Fugl-Meyer test upper limb section at 8 weeks and 12 weeks
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Medical research council score
時間枠:Change from baseline Medical research council score at 8 weeks and 12 weeks
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Muscle strength assessment
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Change from baseline Medical research council score at 8 weeks and 12 weeks
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Active range of motion of the elbow joint
時間枠:Change from baseline active range of motion of the elbow joint at 8 weeks and 12 weeks
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The maximum range of motion to flexion and extension of the elbow joint that the person can achieve independently
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Change from baseline active range of motion of the elbow joint at 8 weeks and 12 weeks
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Passive range of motion of the elbow joint
時間枠:Change from baseline passive range of motion of the elbow joint at 8 weeks and 12 weeks
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The maximum range of motion to flexion and extension of the elbow joint of the test person that can be achieved by the assessor.
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Change from baseline passive range of motion of the elbow joint at 8 weeks and 12 weeks
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Modified Ashworth Scale
時間枠:Change from baseline Modified Ashworth Scale at 8 weeks and 12 weeks
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Spasticity measurement
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Change from baseline Modified Ashworth Scale at 8 weeks and 12 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 |
---|---|---|
ABILHAND questionnaire
時間枠:Change from baseline ABILHAND questionnaire score at 8 weeks and 12 weeks
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Questionnaire-based assessment of manual ability
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Change from baseline ABILHAND questionnaire score at 8 weeks and 12 weeks
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Functional independence measure
時間枠:Change from baseline Functional independence measure score at 8 weeks and 12 weeks
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Assessment of physical and cognitive disability, focusing on the burden of care.
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Change from baseline Functional independence measure score at 8 weeks and 12 weeks
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Stroke impact scale
時間枠:Change from baseline Stroke impact scale score at 8 weeks and 12 weeks
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Questionnaire evaluating how stroke has impacted the person's health and life.
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Change from baseline Stroke impact scale score at 8 weeks and 12 weeks
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Intrinsic motivation inventory
時間枠:Change from baseline Intrinsic motivation inventory score at 8 weeks and 12 weeks
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Multidimensional measurement device intended to assess participants' subjective experience related to a target activity in laboratory experiments.
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Change from baseline Intrinsic motivation inventory score at 8 weeks and 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:Lore Van de Perre, MSc、Thomas More Kempen
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
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
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