Generalizability of Unsupervised Therapy After Stroke in the Home Setting With a Hand Rehabilitation Device (ReHandyBot) (RHB Home SNR)
2026年6月23日 更新者：Swiss Federal Institute of Technology
Generalizability of Unsupervised Therapy After Stroke in the Home Setting With a Hand Rehabilitation Device (ReHandyBot): a Multicentric, Exploratory Study
The ReHandyBot (RHB) is a robot for hand rehabilitation after stroke.
The aims of this study are to investigate (i) the generalizability of unsupervised therapy with the ReHandyBot within patients' home after discharge from a clinic, (ii) compliance, as measured by the amount of unsupervised robot-assisted therapy dose (e.g., therapy time) performed by the subjects after discharge, (iii) the usability of ReHandyBot and user experience during robot-assisted therapy, and (iv) the effect of the increase in therapy dose achieved with our device compared to standard care.
The study consists of two primary phases.
The first is a familiarization phase conducted at the clinic, where therapists teach participants how to perform the exercises using the robot.
Then, if capable of training with the robot safely, after discharge from the clinic, participants can bring the robot home and autonomously train with it.
The hypothesis is that unsupervised therapy might be a possible way to increase therapy dose for stroke patients, with the potential to further improve recovery of hand function, with minimal additional burden for therapists and for the healthcare system.
調査の概要
状態
まだ募集していません
条件
研究の種類
介入
入学 (推定)
40
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。
研究連絡先
- 名前：Giada Devittori, Dr.
- 電話番号：+41 44 510 72 31
- メール：giada.devittori@hest.ethz.ch
研究場所
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Bellikon、スイス、5454
- Rehaklinik Bellikon
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コンタクト：
- Study coordinator
- 電話番号：+41 44 510 72 31
- メール：giada.devittori@hest.ethz.ch
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Geneva、スイス、1211
- University Hospital, Geneva
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コンタクト：
- Study coordinator
- 電話番号：+41 44 510 72 31
- メール：giada.devittori@hest.ethz.ch
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Valens、スイス、7317
- Rehaklinik Valens
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コンタクト：
- Study coordinator
- 電話番号：+41 44 510 72 31
- メール：giada.devittori@hest.ethz.ch
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Zihlschlacht、スイス、8588
- Rehaklinik Zihlschlacht AG
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コンタクト：
- Study coordinator
- 電話番号：+41 44 510 72 31
- メール：giada.devittori@hest.ethz.ch
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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
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Informed Consent signed by the subject;
- female and male patients between 18 and 90 years old;
- acute/subacute stroke (recruitment within 12 weeks from stroke onset);
- pre-stroke modified Rankin score ≤ 1;
- National Institutes of Health Stroke Scale (NIHSS) ≥ 1 in at least one of the items regarding motor functions, sensory functions and ataxia;
- possibility (e.g., enough space) to set up the ReHandyBot at home.
Exclusion Criteria:
- modified Ashworth Scale > 2 for one or more of the following muscles: shoulder adductors, forearm pronator and supinator, flexors and extensors of elbow, wrist and fingers;
- moderate to severe aphasia: Goodglass-Kaplan's scale < 3;
- moderate to severe cognitive deficits: levels of cognitive functioning-revised (LCF-R) < 9;
- functional impairment of the upper limb due to other pathologies;
- severe pain in the affected arm: visual analogue scale for pain (VASp) ≥ 5;
- other pathologies which may interfere with the study;
- after discharge the patient will go to an assisted living facility (e.g., care home).
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：他の
- 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：Unsupervised therapy
This group will perform therapy with the ReHandyBot first with the supervision of a therapist at the rehabilitation clinic.
Then, after discharge, if the participant has learned how to safely train with the device, they can bring the device home and train with it unsupervised.
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During the familiarization phase at the rehabilitation clinics, participants perform one week of supervised and one week of minimally supervised therapy with the ReHandyBot under the supervision of a supervisor (i.e., therapist or researcher).
Minimally supervised therapy means that participants try to perform therapy with the device themselves, while the supervisor is still present but helps only if participants encounter problems or have questions.
During the supervised and minimally supervised phases (first 2 weeks), the intervention consists of 5 sessions of approximately 30 minutes each per week.
These sessions are performed in addition to the conventional therapy plan.
During each session, the robot proposes a set of different exercises targeting the upper limb.
After the familiarization phase, participants train without supervision at the clinic until discharge and then at home for six weeks.
If the therapist thinks that the participant has properly learned how to use the device and can train with it safely, the participant can keep training with the device unsupervised (both at the clinic and at home).
If participants are not ready for unsupervised therapy with the device, they stop the study at the end of the familiarization phase.
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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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教師なし治療の投与量 - 分
時間枠：これは介入中（つまり、自宅での監督なしの治療の6週間中）に測定されます。
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被験者が自宅で監督なしで実施した自己管理型ロボット支援療法の1日あたりの投与量（分単位）。
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これは介入中（つまり、自宅での監督なしの治療の6週間中）に測定されます。
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教師なし治療の投与量 - 繰り返し
時間枠：これは介入中（つまり、自宅での監督なしの治療の6週間中）に測定されます。
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被験者が監督なしで自宅環境で実施した自己管理型ロボット支援療法のタスク反復回数で表した1日当たりの用量。
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これは介入中（つまり、自宅での監督なしの治療の6週間中）に測定されます。
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教師なし治療の線量 - 治療時間の変化率
時間枠：これは介入中（つまり、自宅での監督なしの治療の6週間中）に測定されます。
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参加者が従来の（通常処方された）治療のみを行う場合と比較した、監視なしのロボット治療による治療時間の増加率。
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これは介入中（つまり、自宅での監督なしの治療の6週間中）に測定されます。
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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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実現可能性 - 有害事象
時間枠：これは、プロトコル期間全体（つまり、自宅での監督なし治療の最初の週の初めから6週間の終わりまで）にわたって監視されます。
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この研究中に発生した有害事象の数によって評価された、ReHandyBot による治療の実現可能性。
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これは、プロトコル期間全体（つまり、自宅での監督なし治療の最初の週の初めから6週間の終わりまで）にわたって監視されます。
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実現可能性 - デバイスの欠陥
時間枠：これは、プロトコル期間全体（つまり、自宅での監督なし治療の最初の週の初めから6週間の終わりまで）にわたって監視されます。
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ReHandyBot による治療の実現可能性は、この研究中に発生したデバイスの欠陥の数によって評価されました。
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これは、プロトコル期間全体（つまり、自宅での監督なし治療の最初の週の初めから6週間の終わりまで）にわたって監視されます。
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カスタムロボット評価「aROM - Hand」によって評価された、掴みのアクティブ可動域 (aROM) の変化 (ミリメートル単位で測定)
時間枠：これは、最終測定を行った後、研究の終了時（つまり、自宅での6週間の教師なし治療の終了時）に計算されます。
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ベースライン間での変更 (すなわち、
研究の始まり）と最後（すなわち、
研究の終わり）握るための、つまり手で開閉するためのaROM。
これは、カスタム評価を使用してロボットによって測定されます。
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これは、最終測定を行った後、研究の終了時（つまり、自宅での6週間の教師なし治療の終了時）に計算されます。
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患者が知覚できる剛性の最小差をパーセンテージで測定するカスタムロボット評価「ウェーバーフラクション」によって評価される触覚知覚の変化
時間枠：これは、最終測定を行った後、研究の終了時（つまり、自宅での6週間の教師なし治療の終了時）に計算されます。
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ベースライン間での変更 (すなわち、
研究の始まり）と最後（すなわち、
研究の終わり）触覚知覚。ウェーバー分数の法則に従って、患者が知覚できる剛性の最小差として定義され、パーセンテージで表されます。
これは、「ウェーバー分数」という名前のカスタム評価を使用してロボットによって測定されます。
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これは、最終測定を行った後、研究の終了時（つまり、自宅での6週間の教師なし治療の終了時）に計算されます。
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ロボット療法の内容 - パフォーマンス
時間枠：これは、プロトコル期間全体（つまり、自宅での監督なし治療の最初の週の初めから6週間の終わりまで）にわたって監視されます。
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研究全体にわたるロボット治療中のタスクパフォーマンス（つまり、総トライアル数に対する正しいトライアル数）。
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これは、プロトコル期間全体（つまり、自宅での監督なし治療の最初の週の初めから6週間の終わりまで）にわたって監視されます。
|
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ロボット治療の内容 - 効果時間比率
時間枠：これは、プロトコル期間全体（つまり、自宅での監督なし治療の最初の週の初めから6週間の終わりまで）にわたって監視されます。
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研究全体にわたるロボット治療中の治療セッションの総継続時間に対する有効（つまり、休憩なしの正味合計治療時間）の比率。
|
これは、プロトコル期間全体（つまり、自宅での監督なし治療の最初の週の初めから6週間の終わりまで）にわたって監視されます。
|
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教師なしロボット支援療法に影響を与えるパラメータ
時間枠：これは研究の終了時（つまり、自宅での6週間の監督なし治療の終了時）に計算されます。
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達成された教師なしロボット支援療法の線量とさまざまなパラメータ（すなわち、スクリーニング訪問中に実施された認知評価（グッドグラス・カプランスケール、LCF-R、モントリオール認知評価（MoCA））、臨床評価、ロボット評価、人口統計および統計との間の相関）収集された医療データ）。
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これは研究の終了時（つまり、自宅での6週間の監督なし治療の終了時）に計算されます。
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Feasibility - Subjects performing unsupervised robot-assisted training
時間枠：This is calculated on completion of the study (i.e., in 2 years, right after last subject - last visit).
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Feasibility of unsupervised therapy with the ReHandyBot as assessed by the number of subjects who can transition to unsupervised robot-assisted therapy at home out of the total number of tested subjects.
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This is calculated on completion of the study (i.e., in 2 years, right after last subject - last visit).
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Feasibility - Attendance
時間枠：This is calculated on completion of the study protocol, i.e., at the end of the six weeks of unsupervised therapy at home.
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Feasibility of unsupervised therapy with the ReHandyBot as assessed by attendance during the unsupervised phase at home.
Attendance is measured as the percentage of days where the subject trains at least once without supervision out of the 42 days offered for unsupervised training at home.
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This is calculated on completion of the study protocol, i.e., at the end of the six weeks of unsupervised therapy at home.
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Generalizability of unsupervised therapy with the ReHandyBot
時間枠：This is calculated on completion of the study (i.e., in 2 years, right after last subject - last visit).
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Generalizability is assessed by comparing the feasibility of the intervention across the four sites.
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This is calculated on completion of the study (i.e., in 2 years, right after last subject - last visit).
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Usability as assessed by the System Usability Scale (1)
時間枠：This is measured at the end of the second week of intervention (at the end of the familiarization phase).
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Usability of the ReHandyBot measured with the System Usability Scale.
The possible response options vary between 1 (strongly disagree) and 5 (strongly agree).
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This is measured at the end of the second week of intervention (at the end of the familiarization phase).
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Usability as assessed by the System Usability Scale (2)
時間枠：Usability is measured again after 8 weeks of intervention.
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Usability of the ReHandyBot measured with the System Usability Scale.
The possible response options vary between 1 (strongly disagree) and 5 (strongly agree).
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Usability is measured again after 8 weeks of intervention.
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Usability as assessed by the raw NASA Task Load Index (1)
時間枠：This is measured at the end of the second week of intervention (at the end of the familiarization phase).
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Usability of the ReHandyBot measured with the raw NASA (National Aeronautics and Space Administration) Task Load Index.
Answers range from 0 (low task load) to 100 (high task load).
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This is measured at the end of the second week of intervention (at the end of the familiarization phase).
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Usability as assessed by the raw NASA Task Load Index (2)
時間枠：Usability is measured again after 8 weeks of intervention.
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Usability of the ReHandyBot measured with the raw NASA (National Aeronautics and Space Administration) Task Load Index.
Answers range from 0 (low task load) to 100 (high task load).
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Usability is measured again after 8 weeks of intervention.
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Usability as assessed by the Post-Study System Usability Questionnaire (1)
時間枠：This is measured at the end of the second week of intervention (at the end of the familiarization phase).
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Usability of the ReHandyBot measured with the Post-Study System Usability Questionnaire (version 3).
This questionnaire consists of 16 questions and the possible response options vary between 1 (strongly agree) and 7 (strongly disagree).
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This is measured at the end of the second week of intervention (at the end of the familiarization phase).
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Usability as assessed by the Post-Study System Usability Questionnaire (2)
時間枠：Usability is measured again after 8 weeks of intervention.
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Usability of the ReHandyBot measured with the Post-Study System Usability Questionnaire (version 3).
This questionnaire consists of 16 questions and the possible response options vary between 1 (strongly agree) and 7 (strongly disagree).
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Usability is measured again after 8 weeks of intervention.
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Evolution of patient's satisfaction with robot-assisted therapy as assessed by a 5-point scale
時間枠：This is monitored over the whole protocol duration (i.e., from beginning of the first week to the end of the six weeks of unsupervised therapy at home).
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A 5-point scale is presented by the robot at the end of each therapy session to measure patient's satisfaction with robot-assisted therapy.
The scale ranges from 1 (low satisfaction) to 5 (high satisfaction).
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This is monitored over the whole protocol duration (i.e., from beginning of the first week to the end of the six weeks of unsupervised therapy at home).
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Usability - Intrinsic Motivation Inventory (1)
時間枠：This is measured at the end of the second week of intervention (at the end of the familiarization phase).
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Usability of the gaming environment is measured with the Intrinsic Motivation Inventory (items: Interest/Enjoyment).
The possible response options vary between 1 (not true at all) and 7 (completely true).
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This is measured at the end of the second week of intervention (at the end of the familiarization phase).
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Usability - Intrinsic Motivation Inventory (2)
時間枠：User experience is measured again after 8 weeks of intervention.
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Usability of the gaming environment is measured with the Intrinsic Motivation Inventory (items: Interest/Enjoyment).
The possible response options vary between 1 (not true at all) and 7 (completely true).
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User experience is measured again after 8 weeks of intervention.
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Change in usability
時間枠：This is calculated at the end of the study (i.e., after 8 weeks of intervention).
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Change in usability between the first and second time when it is measured.
This change is used to define how the absence of the therapist during robot-assisted therapy impacts the perceived usability of the device.
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This is calculated at the end of the study (i.e., after 8 weeks of intervention).
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User experience - Customer Satisfaction Score (1)
時間枠：This is measured at the end of the second week of intervention (at the end of the familiarization phase).
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The Customer Satisfaction Score consists of the question "Overall, how satisfied are you with the therapy with ReHandyBot?".
The possible response options vary between 1 (extremely dissatisfied) and 5 (extremely satisfied).
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This is measured at the end of the second week of intervention (at the end of the familiarization phase).
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User experience - Customer Satisfaction Score (2)
時間枠：User experience is measured again after 8 weeks of intervention.
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The Customer Satisfaction Score consists of the question "Overall, how satisfied are you with the therapy with ReHandyBot?".
The possible response options vary between 1 (extremely dissatisfied) and 5 (extremely satisfied).
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User experience is measured again after 8 weeks of intervention.
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User experience - Net Promoter Score (1)
時間枠：This is measured at the end of the second week of intervention (at the end of the familiarization phase).
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The Net Promoter Score consists of the question "How likely would you be to recommend therapy with ReHandyBot to another patient?".
The possible response options vary between 1 (extremely unlikely) and 10 (extremely likely).
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This is measured at the end of the second week of intervention (at the end of the familiarization phase).
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User experience - Net Promoter Score (2)
時間枠：User experience is measured again after 8 weeks of intervention.
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The Net Promoter Score consists of the question "How likely would you be to recommend therapy with ReHandyBot to another patient?".
The possible response options vary between 1 (extremely unlikely) and 10 (extremely likely).
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User experience is measured again after 8 weeks of intervention.
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Change in the user experience
時間枠：This is calculated at the end of the study (i.e., after 8 weeks of intervention).
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Change in user experience between the first and second time when it is measured.
This change is used to define how the absence of the therapist during robot assisted therapy impacts user experience when training with the device.
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This is calculated at the end of the study (i.e., after 8 weeks of intervention).
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Change in upper limb functions as assessed by the Fugl-Meyer Assessment of Upper Extremities (FMA-UE)
時間枠：This is calculated at the end of the study, after performing the final measurements (i.e., at the end of the six weeks of unsupervised therapy at home).
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Change between midterm (i.e., at discharge from the clinic) and final (i.e., end of the study) upper limb functions as assessed by the FMA-UE.
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This is calculated at the end of the study, after performing the final measurements (i.e., at the end of the six weeks of unsupervised therapy at home).
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Change in upper limb functions as assessed by the ABILHAND
時間枠：This is calculated at the end of the study, after performing the final measurements (i.e., at the end of the six weeks of unsupervised therapy at home).
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Change between midterm (i.e., at discharge from the clinic) and final (i.e.
end of the study) upper limb functions as assessed by the ABILHAND scale.
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This is calculated at the end of the study, after performing the final measurements (i.e., at the end of the six weeks of unsupervised therapy at home).
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Change in upper limb functions as assessed by the Box and Block (BBT) test
時間枠：This is calculated at the end of the study, after performing the final measurements (i.e., at the end of the six weeks of unsupervised therapy at home).
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Change between midterm (i.e., at discharge from the clinic) and final (i.e.
end of the study) upper limb functions as assessed by the BBT test.
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This is calculated at the end of the study, after performing the final measurements (i.e., at the end of the six weeks of unsupervised therapy at home).
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Change in upper limb functions as assessed by the modified Ashworth Scale (mAS)
時間枠：This is calculated at the end of the study, after performing the final measurements (i.e., at the end of the six weeks of unsupervised therapy at home).
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Change between midterm (i.e., at discharge from the clinic) and final (i.e., end of the study) upper limb functions as assessed by the mAS.
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This is calculated at the end of the study, after performing the final measurements (i.e., at the end of the six weeks of unsupervised therapy at home).
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Change in proprioception as assessed by the custom robotic assessment "JND" measuring the minimum difference in hand positioning that a patient can perceive
時間枠：This is calculated at the end of the study, after performing the final measurements (i.e., after 8 weeks of intervention).
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Change between baseline (i.e.
beginning of the study) and final (i.e.
end of the study) proprioception, defined as the minimum difference in the hand position that a patient can perceive (i.e.
just noticeable difference).
This is measured by the robot with a custom assessment.
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This is calculated at the end of the study, after performing the final measurements (i.e., after 8 weeks of intervention).
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Content of robotic therapy - Intensity (repetitions of a therapy task over time)
時間枠：This is monitored over the whole protocol duration (i.e., from beginning of the first week to the end of the six weeks of unsupervised therapy at home).
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Intensity (i.e., repetitions of a therapy task over time) of the robotic therapy throughout the study.
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This is monitored over the whole protocol duration (i.e., from beginning of the first week to the end of the six weeks of unsupervised therapy at home).
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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：Bertrand Léger, Dr.、Responsible for research at the SUVA clinics (Bellikon and Sion)
- 主任研究者：Roman Gonzenbach, Dr. med. Dr. sc. nat.、Rehaklinik Valens
- 主任研究者：René Müri, Prof. Dr. med.、Rehaklinik Zihlschlacht AG
- 主任研究者：Mauro Silva, Dr. med.、University Hospital, Geneva
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 (推定)
2026年7月1日
一次修了 (推定)
2028年5月30日
研究の完了 (推定)
2028年8月30日
試験登録日
最初に提出
2026年6月16日
QC基準を満たした最初の提出物
2026年6月23日
最初の投稿 (実際)
2026年6月29日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月29日
QC基準を満たした最後の更新が送信されました
2026年6月23日
最終確認日
2026年6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。