Usability Testing of Affordable Haptic Robots for Stroke Therapy (Theradrive)
2020年9月3日 更新者：University of Pennsylvania
Stroke survivors with hemiplegia will be evaluated by rehabilitation professionals and asked to perform a battery of assessments to test the viability and usability of a force-feedback robot that adapts to each individual subject's performance.
Subsequently, they will be asked to complete post-assessment questionnaires that provide feedback to the researchers on their observations and thoughts about the therapy devices.
調査の概要
詳細な説明
TheraDrive is a low-cost robotic system for post-stroke upper extremity rehabilitation.
The system uses off-the-shelf computer gaming wheels with force feedback to help reduce motor impairment and improve function in the arms of stroke survivors.
Preliminary results from various studies have shown that the original TheraDrive system lacked a robust mechanical linkage which could withstand the forces exerted by patients, lacked a patient-specific adaptive controller to deliver personalized therapy, and was not capable of delivering effective therapy to severely low-functioning patients.
A new low-cost, high-force haptic robot with a single degree of freedom has been developed to address these concerns.
This study has two purposes: first, to test the viability and usability of the new robot system alongside the original TheraDrive system; and second, to test if low-functioning patients benefit, and if so how much, from using force-feedback therapy as opposed to devices with zero impedance.
This will be done by recruiting approximately 36 human subjects.
Exercises will be performed by study subjects and an adaptive controller will monitor patient performance to ensure that exercises are difficult but doable, which is important for maintaining patient motivation.
It is hypothesized that not only will the new system be viable, but that it will provide better robot-assisted therapy to a large variety of patients, especially low-functioning stroke survivors with hemiplegia.
研究の種類
介入
入学 (実際)
23
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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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19146
- Penn Medicine Rittenhouse
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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
18年歳以上 (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:
- Stroke survivors at least 18 years of age with hemiplegia.
- The subject's stroke must have occurred at least 3 months prior to enrollment in the study.
- Low and Moderate functioning stroke survivors as measured by Fugl- Meyer
- Not depressed
- No more than Mild Cognitive Deficit
- Participants must be able to sit upright for 4 hours at a time in Part A of the study; and 2 hours at a time, 3 days a week, for Part B of the study.
- The subject's stroke must have occurred at least 3 months prior to enrollment in the study.
Exclusion Criteria:
- Greater than mild cognitive deficits
- Greater than mild depression. A member of the research team will administer Beck's Depression Inventory (BDI) to each study participant over the phone. If the participant is found to have greater than mild depression, as measured by the BDI, they will not qualify for the study.
- Receiving rehabilitation on the upper limb.
- Received Botox injections within the past 3 months.
- Suffering from contractures (chronic loss of joint motion) or debilitating spasticity in the upper extremity.
- Experiencing greater than mild pain, and/or the PI determines that the participant should no longer continue working with the novel therapy devices, the study will be stopped.
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：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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他の：Stroke survivors with low and moderate motor deficits
Subjects with low and moderate motor deficits will 1) complete exercises with 2 commercial (joystick and wheel) and the Theradrive haptic robot after pre assessment 2) then experience 12 therapy sessions on the Theradrive haptic robot with Adaptive Feedback.
3) Assessments pre and post therapy.
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Commercial Joystick and Wheels Plus the Haptic TheraDrive Robot will be used.
Haptic Theradrive is a low-cost robotic system for post-stroke upper extremity rehabilitation.
The system uses off-the-shelf computer gaming wheels with force feedback to help reduce motor impairment and improve function in the arms of stroke survivors.
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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
時間枠：At 0 weeks
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The primary outcomes are motor control for the upper limb: Subjects completed tasks on scale; Motor scale maximum is 66. minimum is 0. Lower is more impaired.
Higher is less impaired.
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At 0 weeks
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Box and Blocks
時間枠：At Session 0. Pre-intervention
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Measures ADL Function.
Completed reach and grasp activities.
Reached for 1 inch cube and placed with impaired arm.
More blocks indicate higher function.
Less blocks lower function
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At Session 0. Pre-intervention
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Tracking Accuracy
時間枠：At Session 0
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Tracking accuracy is measured using the normalized root mean square, which is a measure for error in tracking performance with respect to a desired goal.
Root mean squared divided by the maximum error if person does not move.
The higher the decimal the higher the error made.
Lower is better performance.
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At Session 0
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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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Grip Strength
時間枠：pre-intervention
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Grip strength as measured by a dynamometer.
Subjects were asked to squeeze a dynamometer with impaired arm.
Higher forces mean better function
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pre-intervention
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Montreal Cognitive Assessment (MOCA)
時間枠：pre-intervention
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A brief 30-question test that takes around 10 to 12 minutes to complete and helps assess people for impairment in cognition domains.
Maximum is 30.
Minimum is 0; Low is <17 is severe cognitive impairment; a score 26 and higher is normal cognition.
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pre-intervention
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Becks Depression Scale
時間枠：Pre-intervention
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Measures depression.
The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression (Beck, et al., 1961).
Maximum is 63 Total Score_______________Levels of Depression 1-10____________________These ups and downs are considered normal 11-16___________________ Mild mood disturbance 17-20___________________Borderline clinical depression 21-30___________________Moderate depression 31-40___________________Severe depression over 40__________________Extreme depression
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Pre-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。
捜査官
- 主任研究者：Michelle J Johnson, PhD、Penn Medicine Rittenhouse
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。
一般刊行物
- Ruparel R, Johnson MJ, Strachota E, McGuire J, Tchekanov G. Evaluation of the TheraDrive system for robot/computer assisted motivating rehabilitation after stroke. Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:811-4. doi: 10.1109/IEMBS.2009.5332386.
- Johnson MJ, Ramachandran B, Paranjape RP, Kosasih JB. Feasibility study of TheraDrive: a low-cost game-based environment for the delivery of upper arm stroke therapy. Conf Proc IEEE Eng Med Biol Soc. 2006;2006:695-8. doi: 10.1109/IEMBS.2006.259971.
- Theriault A, Nagurka M, Johnson MJ. Design and development of an affordable haptic robot with force-feedback and compliant actuation to improve therapy for patients with severe hemiparesis. IEEE Trans Haptics. 2014 Apr-Jun;7(2):161-74. doi: 10.1109/TOH.2013.51.
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 (実際)
2014年3月1日
一次修了 (実際)
2017年7月1日
研究の完了 (実際)
2017年7月1日
試験登録日
最初に提出
2016年3月29日
QC基準を満たした最初の提出物
2016年5月11日
最初の投稿 (見積もり)
2016年5月16日
学習記録の更新
投稿された最後の更新 (実際)
2020年9月4日
QC基準を満たした最後の更新が送信されました
2020年9月3日
最終確認日
2020年9月1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。