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.
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;
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;
Single group
Supervised and minimally supervised therapy with ReHandyBot
DeviceDuring 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.
Unsupervised therapy
DeviceAfter 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.
Dose of unsupervised therapy - Minutes
Daily dose in minutes of self-administered robot-assisted therapy performed by subjects in the home setting without supervision.
Dose of unsupervised therapy - Repetitions
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
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.
Feasibility - Adverse events
Feasibility of therapy with the ReHandyBot as assessed by the number of adverse events occurring during this study.
Feasibility - Device deficiencies
Feasibility of therapy with the ReHandyBot as assessed by the number of device deficiencies occurring during this study.
Feasibility - Subjects performing unsupervised robot-assisted training
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.
Feasibility - Attendance
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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Swiss Federal Institute of Technology
Lead sponsor
Kliniken Valens
Collaborator
Rehaklinik Bellikon
Collaborator
Rehaklinik Zihlschlacht AG
Collaborator
University Hospital, Geneva
Collaborator
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