Feasibility of Home-based Virtual Reality Rehabilitation for the Upper Extremity in Subacute and Chronic Stroke
Regaining upper extremity function is very important for stroke survivors to increase their independence and ability to perform activities of daily living (ADLs). Outpatient stroke rehabilitation currently takes place in a therapy clinic, however access can be limited by financial resources and transportation difficulties.
The Feasibility of Home-Based Virtual Reality Rehabilitation for the Upper Extremity in Subacute and Chronic Stroke Study seeks to explore the safety, usability, and efficacy of a home based virtual reality biofeedback system to promote distal upper extremity (wrist and hand) recovery after stroke. The purpose of the study is to assess the feasibility of using a home-based virtual reality system to increase the dose of upper extremity rehabilitation in subacute and chronic stroke patients.
調査の概要
詳細な説明
In this pilot study, we propose to test a virtual reality home-based intervention as an alternative or supplement to traditional rehabilitation for upper extremity weakness after stroke. We are hoping to discover that the device is easily adopted by patients and increases the dose of rehabilitation, as well as potentially leads to motor recovery.
With the increasing affordability and accessibility of virtual reality (VR) systems, VR has emerged as a new platform for stroke rehabilitation. VR therapy involves using computer-based programs to simulate daily tasks and events. VR has shown promise in both allowing patients to practice activities that directly translate to their ADLs, as well as motivating them by providing a novel and interesting virtual environment.
Relevance Regaining upper extremity function is very important for stroke survivors to increase their independence and ability to perform ADLs. The large majority of outpatient stroke rehabilitation currently takes place in a therapy clinic, however access is often limited by resource allocation, financial hardship, and transportation difficulties. The Smart Glove can provide an inexpensive and convenient means for stroke patients to continue their rehabilitation in the comfort of their own home.
Patient Population Subacute and chronic stroke patients presenting with upper extremity weakness, as identified by Stanford physicians in clinic, will be eligible for participation in this study. Patients will be screened and selected from the population of people with strokes who are seen in the Stanford Neuroscience Clinic. Patients will be allowed to participate in any scheduled outpatient rehabilitation during the study. The doctor and/or research coordinator may introduce the study to potential candidates in-person in the Stanford Neurology Clinic, and the research coordinator may contact potential candidates by phone after the doctor's referral.
Procedures:
Once the participant has given informed consent and enrolled in the study, they will have a total of five visits, with one visit every two weeks.
Visit one will entail the participant and identified caregiver undergoing training on the use of the Smart Glove by the research coordinator and Neofect staff. This involves donning/doffing of the glove as well as instruction as to how to use the software program. The participant will be issued a Smart Glove and a tablet preloaded with the software. Subjects will also undergo baseline functional testing, including manual muscle testing (MMT), Fugl-Meyer assessment (FM), Jebsen-Taylor hand function test (JTT), and Stroke Impact Scale (SIS). This first visit is expected to take 60-90 minutes. The participant will be expected to use the Smart Glove for 60 min per day for at least 5 days per week.
The subsequent three visits will be at two week intervals and will involve the participant bringing the device to the Clinical and Translational Research Unit (CTRU). The research coordinator will upload the data from the device as well as troubleshoot any device-related issues. These visits will last 15-30 minutes each.
The final visit will occur after eight weeks of Smart Glove use. In addition to downloading the data, the research coordinator will also repeat functional testing functional testing, including manual muscle testing (MMT), Fugl-Meyer assessment (FM), Jebsen-Taylor hand function test (JTT), and Stroke Impact Scale (SIS). This visit will last 45-60 minutes.
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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California
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Stanford、California、アメリカ、94305
- Stanford Hospital and Clinics
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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:
- 1) Age 18 and older 2) Diagnosis of stroke at least three months prior to enrollment 3) Unilateral upper extremity functional deficit after stroke 4) Presence of a score of at least 2 points on the medical research council scale for wrist flexion/extension or forearm pronation/supination 5) Able to provide informed consent 6) Caregiver who is willing to be trained in use of the Smart Glove
Exclusion Criteria:
- 1) Predisposing psychological disorders which could impede participation 2) Severe aphasia resulting in communication difficulties 3) Severe pain impeding upper extremity rehabilitation 4) Pre-existing neurological disorder that causes motor deficits (i.e. Parkinson's disease)
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: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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実験的:Single Arm - Intervention arm
RAPAEL Smart Glove Arm The participant will be issued a Smart Glove and a tablet preloaded with the game software.
The available games provide various kinds of motion tasks such as ADL-related tasks presented in an entertaining manner.
The learning schedule algorithm automatically adjusts to the optimal level of difficulty to balance challenge and motivation.
The participant will be expected to use the Smart Glove at home for 60 min per day for at least 5 days per week.
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The RAPAEL Smart Glove is a commercially available, non-invasive biofeedback based system for distal upper extremity rehabilitation.
The Smart Glove is very lightweight and allows for easy movement of all distal upper extremity joints.
It is made of an elastomer material that is simple to maintain and clean.
The Bending Sensor is a variable resistor that changes as it is bent.
The sensor is a 9-axis movement and position sensor that consists of 3 acceleration channels, 3 angular rate channels, and 3 magnetic field channels that measure wrist movements.
They are connected to a computer system which can accurately compute the amount of individual finger movements.
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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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Device Use
時間枠:8 weeks
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Number of days during 8 week study-period that patient used the device.
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8 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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Device Use Daily Average Per Use Day
時間枠:8 weeks
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Daily average number of minutes of device-use per days that device was used.
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8 weeks
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Device Use Daily Average
時間枠:8 weeks
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Daily average number of minutes of device-use during 8-week intervention period.
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8 weeks
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Jebsen-Taylor Hand Function Test - Overall Score
時間枠:8 weeks
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Time (in seconds) to complete the total Jebsen-Taylor Hand Function Test administered at 8-weeks.
The test consists of 7 subtests.
Each subtest is allotted a maximum time of 90 seconds.
The total score is the sum of the scores of the seven subtests.
The total score has a maximum of 630 seconds and there is no minimum.
Longer time to complete the test indicates worse hand function.
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8 weeks
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Jebsen-Taylor Hand Function Test - Fine Score
時間枠:8 weeks
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Time (in seconds) to complete the four fine-motor subtests of the Jebsen-Taylor Hand Function Test administered at 8-weeks.
Each of the four subtests is allotted a maximum time of 90 seconds.
The total score is the sum of the scores of the four subtests.
The total score has a maximum of 360 seconds and there is no minimum.
Longer time to complete the test indicates worse hand function.
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8 weeks
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Jebsen-Taylor Hand Function Test - Gross Score
時間枠:8 weeks
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Time (in seconds) to complete the three gross-motor subtests of the Jebsen-Taylor Hand Function Test administered at 8-weeks.
Each of the three gross-motor subtests is allotted a maximum time of 90 seconds.
The total gross-motor score is the sum of the scores of the three subtests.
The total score has a maximum of 270 seconds and there is no minimum.
Longer time to complete the test indicates worse hand function.
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8 weeks
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Fugl-Meyer Assessment
時間枠:8 weeks
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Upper Extremity Fugl-Meyer Test score at 8-weeks.
Score ranges from 0 to 66, with higher scores corresponding to better arm function.
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8 weeks
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Manual Muscle Testing (MMT) Score
時間枠:8 weeks
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The MMT score is the sum of the Medical Research Council (MRC) scores across 5 domains (elbow flexor, elbow extensor, wrist extension, finger extension and finger flexion) at 8 weeks.
Each domain has a scale range of 0 to 5, with higher scores corresponding to better strength.
Maximum MMT score ranges from 0-25, with higher scores corresponding to better strength.
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8 weeks
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Stroke Impact Scale (SIS)
時間枠:8 weeks
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Score on the SIS at 8-weeks.
The score ranges from 0 to 100, with higher scores corresponding to better recovery from stroke.
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8 weeks
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Patient Experience
時間枠:8 weeks
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Patient self-reported satisfaction with device use (5-point Likert Scale, with higher scores indicating greater satisfaction).
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8 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:Kara Flavin, MD、Stanford University
- 主任研究者:Maarten Lansberg, MD、Stanford University
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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