Unsupervised Therapy After Stroke in the Home Setting with a Hand Rehabilitation Device (ReHandyBot)

NCT ID: NCT06057129

Last Updated: 2024-11-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-13
• Study Completion Date: 2026-04-30

Brief Summary

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.

Conditions

Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

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 learnt how to safely train with the device, they can bring the device home and train with it unsupervised. On the other hand, if participants are not capable of training without supervision, after discharge they perform unsupervised therapy at home with a booklet of exercises (i.e., without the robot).

Group Type: EXPERIMENTAL

Supervised and minimally-supervised therapy with ReHandyBot

Intervention Type: DEVICE

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 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

Intervention Type: DEVICE

After 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.

Interventions

Supervised and minimally-supervised therapy with ReHandyBot

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 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.

Intervention Type: DEVICE

Unsupervised therapy

After 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.

Intervention Type: DEVICE

Other Intervention Names

Familiarization phase

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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;
• pacemakers and other active implants;
• after discharge the patient will go to an assisted living facility (e.g., care home).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinica Hildebrand Brissago

OTHER

Sponsor Role: collaborator

Swiss Federal Institute of Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paolo Rossi, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Clinica Hildebrand Brissago

Locations

Clinica Hildebrand Centro di riabiliazione Brissago

Brissago, Canton Ticino, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Giada Devittori, M. Sc.

Role: CONTACT

giada.devittori@hest.ethz.ch

+41 44 510 72 31

Facility Contacts

Giada Devittori, M. Sc.

Role: primary

giada.devittori@hest.ethz.ch

+41 44 510 72 31

Other Identifiers

RHB Home

Identifier Type: -

Identifier Source: org_study_id