Unsupervised Therapy After Stroke in the Home Setting with a Hand Rehabilitation Device (ReHandyBot)

Официальное название

Feasibility of Unsupervised Therapy After Stroke in the Home Setting with a Hand Rehabilitation Device (ReHandyBot): an Exploratory Study

Обзор

The ReHandyBot is a robot for hand rehabilitation after stroke. The aims of this study are (1) to investigate the feasibility of unsupervised therapy with the ReHandyBot with stroke inpatients, first in a rehabilitation clinic and then at participants' home, (2) to evaluate the usability of the ReHandyBot (user interface, implemented exercises, and gaming environment, which were adapted for independent usage), and (3) to quantify the dose of additional robotic therapy that patients perform without supervision. The study consists of two primary phases. The first is a familiarization phase performed at the clinic, where therapists teach to the participants how to perform the exercises with 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 clinic, 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 by themselves, while the supervisor is still present but helps only in case participants encounter problems or if they have any questions. During the supervised and
• 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 have properly learnt 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 receive a booklet of exercises to perform without supervision (both at t

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., right after last subject - last visit).]
• Feasibility - Attendance [Срок оценки: This is calculated on completion of the study protocol.]
• Usability as assessed by the System Usability Scale (1) [Срок оценки: This is measured during the intervention (at the end of the familiarization phase).]
• Usability as assessed by the System Usability Scale (2) [Срок оценки: Usability is measured again at the end of the study protocol (i.e., at the end of the six weeks of unsupervised therapy at home).]
• Usability as assessed by the raw NASA Task Load Index (1) [Срок оценки: This is measured during the 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 at the end of the study protocol (i.e., at the end of the six weeks of unsupervised therapy at home).]
• Usability as assessed by the Post-Study System Usability Questionnaire (1) [Срок оценки: This is measured during the 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 at the end of the study protocol (i.e., at the end of the six weeks of unsupervised therapy at home).]
• 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).]
• Usability - Intrinsic Motivation Inventory (1) [Срок оценки: This is measured during the intervention (at the end of the familiarization phase).]

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;
• pacemakers and other active implants;
• 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

Оценка устройства

Центры проведения

Швейцария · 1 центр

• Clinica Hildebrand Centro di riabiliazione Brissago — Brissago

Идентификаторы

NCT: NCT06057129 · RHB Home

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗