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.
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 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 minimally-supervised phases (first 2 weeks), the intervention dose is 5 sessions of approximately 45 minutes per week. These sessions are performed in addition to the conventional therapy plan. During each session, the robot proposes a set of 3 exercises, each lasting between 10 and 15 minutes.
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 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 the clinic and at home). These exercises do not imply the use of the robot but are exercises discussed with the therapists and meaningful for the specific patient.
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
Clinica Hildebrand Brissago
Collaborator
