The goal of this clinical trial is to evaluate whether using the ReHandyBot hand rehabilitation device together with the RehabCoach smartphone app can support safe, independent, and effective home therapy in patients with stroke, traumatic brain injury, or orthopedic problems.
The main questions it aims to answer are:
* Can patients safely and independently use ReHandyBot and RehabCoach after leaving the clinic? * Will patients follow the recommended daily therapy schedule when using these tools at home? * How do patients experience the usability and acceptability of ReHandyBot and RehabCoach in everyday life? * Can this type of home-based therapy be extended to populations beyond stroke, such as traumatic brain injury and orthopedic patients?
Participants will:
* Complete a screening and baseline assessment with a therapist. * Use ReHandyBot in a supervised phase at the clinic (3 sessions of 30 minutes). * Continue with a minimally supervised phase at the clinic (3-7 sessions of 30 minutes, with daily app use). * If ready, enter the unsupervised phase, taking ReHandyBot home for daily 30-minute training sessions, supported by RehabCoach. * Return for a final assessment including clinical and robotic evaluations and usability feedback.
Informed Consent signed by the subject.
Female and male patients between 18 and 90 years old.
Stroke or traumatic brain injury (recruitment within 6 months from event onset).
Presence of a motor and/or sensory impairment of the upper limb as assessed by the responsible therapist.
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 and RehabCoach
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 therapist or researcher. Minimally-supervised therapy means that participants try to perform therapy independently with the device, while the supervisor is present to provide assistance only if problems occur or if participants have questions. A few days after the study begins, participants are introduced to the RehabCoach application, which provides conversational support, reminders, and educational content throughout the intervention. 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. In each session, the robot proposes a set of 3 exercises, each lasting between 10 and 15 minutes.
Unsupervised Therapy with ReHandyBot and RehabCoach
DeviceAfter the familiarization phase, participants continue training without direct supervision at the clinic until discharge and then at home for six weeks. If the therapist considers the participant capable of training safely and effectively with the device, the participant will keep training with the ReHandyBot unsupervised, both at the clinic and at home, while supported by the RehabCoach application. RehabCoach provides reminders, motivational support, and educational material to guide the home-based therapy. If participants are not considered ready for unsupervised therapy with the device, they will not proceed to the unsupervised phase.
Dose of unsupervised therapy - Minutes
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 - App deficiencies
Feasibility of support via RehabCoach as assessed by the number of app deficiencies occurring during this study.
Feasibility - Number of 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.
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Swiss Federal Institute of Technology
Lead sponsor
Rehaklinik Bellikon
Collaborator
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