Generalizability of Unsupervised Therapy After Stroke in the Home Setting With a Hand Rehabilitation Device (ReHandyBot): a Multicentric, Exploratory Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Dose of unsupervised therapy - Minutes
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: Supervised and minimally supervised therapy with ReHandyBot (Device)
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.
干预措施: Unsupervised therapy (Device)
结局指标
主要结局
Dose of unsupervised therapy - Minutes
时间窗: This is measured during the intervention (i.e., during the six weeks of unsupervised therapy at home).
Daily dose in minutes of self-administered robot-assisted therapy performed by subjects in the home setting without supervision.
Dose of unsupervised therapy - Repetitions
时间窗: This is measured during the intervention (i.e., during the six weeks of unsupervised therapy at home).
Daily dose in number of task repetitions of self-administered robot-assisted therapy performed by subjects in the home setting without supervision.
Dose of unsupervised therapy - Percentual change in therapy time
时间窗: This is measured during the intervention (i.e., during the six weeks of unsupervised therapy at home).
Percentage increase in therapy time due to the unsupervised robotic therapy compared to the case where the participants would perform conventional (i.e., normally prescribed) therapy only.
次要结局
- Feasibility - Adverse events(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(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(This is calculated on completion of the study (i.e., in 2 years, right after last subject - last visit).)
- Feasibility - Attendance(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(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)(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)(Usability is measured again after 8 weeks of intervention.)
- Usability as assessed by the raw NASA Task Load Index (1)(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)(Usability is measured again after 8 weeks of intervention.)
- Usability as assessed by the Post-Study System Usability Questionnaire (1)(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)(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(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)(This is measured at the end of the second week of intervention (at the end of the familiarization phase).)
- Usability - Intrinsic Motivation Inventory (2)(User experience is measured again after 8 weeks of intervention.)
- Change in usability(This is calculated at the end of the study (i.e., after 8 weeks of intervention).)
- User experience - Customer Satisfaction Score (1)(This is measured at the end of the second week of intervention (at the end of the familiarization phase).)
- User experience - Customer Satisfaction Score (2)(User experience is measured again after 8 weeks of intervention.)
- User experience - Net Promoter Score (1)(This is measured at the end of the second week of intervention (at the end of the familiarization phase).)
- User experience - Net Promoter Score (2)(User experience is measured again after 8 weeks of intervention.)
- Change in the user experience(This is calculated at the end of the study (i.e., after 8 weeks of intervention).)
- Change in upper limb functions as assessed by the Fugl-Meyer Assessment of Upper Extremities (FMA-UE)(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).)
- Change in upper limb functions as assessed by the ABILHAND(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).)
- Change in upper limb functions as assessed by the Box and Block (BBT) test(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).)
- Change in upper limb functions as assessed by the modified Ashworth Scale (mAS)(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).)
- Change in the active Range of Motion (aROM) for grasping measured in millimeters as assessed by the custom robotic assessment "aROM - Hand"(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).)
- Change in proprioception as assessed by the custom robotic assessment "JND" measuring the minimum difference in hand positioning that a patient can perceive(This is calculated at the end of the study, after performing the final measurements (i.e., after 8 weeks of intervention).)
- Change in haptic perception as assessed by the custom robotic assessment "Weber Fraction" measuring the minimum difference in stiffness that a patient can perceive in percentage(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).)
- Content of robotic therapy - Intensity (repetitions of a therapy task over time)(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).)
- Content of robotic therapy - Performance(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).)
- Content of robotic therapy - Effective time ratio(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).)
- Parameters influencing unsupervised robot-assisted therapy(This is calculated at the end of the study (i.e., at the end of the six weeks of unsupervised therapy at home).)