Feasibility of Unsupervised Therapy After Neurological or Orthopaedical Injury in the Home Setting With a Hand Rehabilitation Device (ReHandyBot) and an Assistive Smartphone Application (RehabCoach)

Summary

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.

Conditions

• Rehabilitation After Neurological or Orthopaedic Injuries

Interventions

DEVICE

Supervised and minimally-supervised therapy with ReHandyBot and RehabCoach

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 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.

DEVICE

Unsupervised Therapy with ReHandyBot and RehabCoach

After 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.

Sponsors & Collaborators

• Rehaklinik Bellikon

  collaborator OTHER

• Swiss Federal Institute of Technology

  lead OTHER

Principal Investigators

• Olivier Lambercy, Prof. Dr. · Swiss Federal Institute of Technology Zurich

Study Design

Allocation

NON_RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-15

Primary Completion

2028-08-01

Completion

2028-08-01