Robot-Assisted Motivating Rehabilitation
Robot-Assisted Motivating Rehabilitation to Increase Upper Limb Function After Stroke
調査の概要
詳細な説明
Typically, after brain damage due to a stroke, the affected arm is weak and suffering from some of paralysis. As a result, adults with this condition are unable to move their impaired arm well during their activities of daily living. Our research is focused on understanding how best to improve the ability of the arm to move after brain damage due to a stroke. We have implemented novel robot technology designed for eventual use as a home therapy device and have used software and hardware technologies to design activities that can assess the arm ability and engage the person during therapy. We will study how the prolong use of this device with simple, functional, and engaging activities improve the arm's movement ability and sustain motivation to use the arm over repeated therapy sessions and away from supervision.
Overall, we will establish whether using our technology to perform tasks that are more or less game-like and functionally relevant to driving will make a difference in the impaired arm after stroke. Two groups of stroke survivors will be followed while they complete therapy. We have three main aims. In aim #1, we will determine whether therapy using functional tasks compared to simple rote tasks lead to significant increases in the use of the arm during therapy and the arm improvements experienced by the subjects after the therapy. In aim #2, we will measure how each group engage in the more and less functional therapy and monitor their effort and enjoyment during training. This aim will help us to determine the value of more fun training. In aim #3, we will upgrade our technology for use in the home therapy environment and follow some subjects to determine if the results change in under supervised condition (at home)
研究の種類
入学 (予想される)
段階
- フェーズ 1
連絡先と場所
研究場所
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Wisconsin
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Milwaukee、Wisconsin、アメリカ、53295
- Clement J Zablocki VA - Rehabilitation Robotics R&D Lab
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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:
Subjects will be included in the study on the basis of the following criteria:
- They must be at least six months post-stroke.
- 18 years of age or older with a clinical diagnosis of hemiparesis (as verified by medical record and a medical expert).
- They have voluntary control with a low to medium range of motion function (UE-FT<5) and a muscle tone.
- They are functionally stable (no significant changes in motor function over a week) and are able to tolerate being seated upright for 90 minutes.
- They report no excessive pain the impaired arm.
- If left neglect or spasticity is detected in the impaired arm, these levels must not interfere with the ability to cognitively complete the tasks or turn a wheel.
- They must not be participating in any experimental rehabilitation or drug therapies.
- If subjects are receiving chemical injections for spasticity, they must be at least 3-months away from their last treatment.
- They must have driven prior to stroke.
- They are not clinically depressed (as measured by the Geriatric Depression Scale (GDS) short form (Sheikh and Yesavage, 1986).
Exclusion Criteria:
- Subjects will be excluded from the study if they voluntarily decide to withdraw from the study or if they do not meet the above inclusion criteria.
Once informed consent is given twenty-four of these subjects will be randomized into two training groups (fun driving: fun and functional driving activities and rote tracking (12 subjects): rote and functional tracking activities). Two subjects will be randomized the case study group. The groups will be matched in initial motor function.
Subjects will be excluded if they voluntarily decide to withdraw from the study or if they do not meet the above inclusion criteria.
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:非ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
協力者と研究者
捜査官
- 主任研究者:Michelle J Johnson, PhD、Medical College of Wisconsin
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。
TheraDrive Assistive Deviceの臨床試験
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Ohio State UniversityMedical University of South Carolina; Northwestern University終了しました
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Cardiva Medical, Inc.完了