Generalizability of Unsupervised Therapy After Stroke in the Home Setting With a Hand Rehabilitation Device (ReHandyBot)

Официальное название

Generalizability of Unsupervised Therapy After Stroke in the Home Setting With a Hand Rehabilitation Device (ReHandyBot): a Multicentric, Exploratory Study

Обзор

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.

Вмешательства

• Устройство Supervised and minimally supervised therapy with ReHandyBot
  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 supervise
• Устройство Unsupervised therapy
  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.

Первичные конечные точки

• Dose of unsupervised therapy - Minutes [Срок оценки: This is measured during the intervention (i.e., during the six weeks of unsupervised therapy at home).]
• Dose of unsupervised therapy - Repetitions [Срок оценки: This is measured during the intervention (i.e., during the six weeks of unsupervised therapy at home).]
• Dose of unsupervised therapy - Percentual change in therapy time [Срок оценки: This is measured during the intervention (i.e., during the six weeks of unsupervised therapy at home).]

Вторичные конечные точки (12)

• Feasibility - Adverse events [Срок оценки: 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).]
• Feasibility - Device deficiencies [Срок оценки: 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).]
• Feasibility - Subjects performing unsupervised robot-assisted training [Срок оценки: This is calculated on completion of the study (i.e., in 2 years, right after last subject - last visit).]
• Feasibility - Attendance [Срок оценки: This is calculated on completion of the study protocol, i.e., at the end of the six weeks of unsupervised therapy at home.]
• Generalizability of unsupervised therapy with the ReHandyBot [Срок оценки: This is calculated on completion of the study (i.e., in 2 years, right after last subject - last visit).]
• Usability as assessed by the System Usability Scale (1) [Срок оценки: This is measured at the end of the second week of intervention (at the end of the familiarization phase).]
• Usability as assessed by the System Usability Scale (2) [Срок оценки: Usability is measured again after 8 weeks of intervention.]
• Usability as assessed by the raw NASA Task Load Index (1) [Срок оценки: This is measured at the end of the second week of intervention (at the end of the familiarization phase).]
• Usability as assessed by the raw NASA Task Load Index (2) [Срок оценки: Usability is measured again after 8 weeks of intervention.]
• Usability as assessed by the Post-Study System Usability Questionnaire (1) [Срок оценки: This is measured at the end of the second week of intervention (at the end of the familiarization phase).]
• Usability as assessed by the Post-Study System Usability Questionnaire (2) [Срок оценки: Usability is measured again after 8 weeks of intervention.]
• Evolution of patient's satisfaction with robot-assisted therapy as assessed by a 5-point scale [Срок оценки: 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).]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Швейцария · 4 центра

• Rehaklinik Bellikon — Bellikon
• University Hospital, Geneva — Geneva
• Rehaklinik Valens — Valens
• Rehaklinik Zihlschlacht AG — Zihlschlacht

Идентификаторы

NCT: NCT07674238 · RHB Home SNR

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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