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

NCT06057129 | Recruiting

• 1 other identifier: RHB Home
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Keywords

Stroke; Hand impairment; Robot-assisted therapy; Unsupervised therapy; Neurorehabilitation

Outcome Measures

Primary Outcomes (3)

• Dose of unsupervised therapy - Minutes

  Daily dose in minutes of self-administered robot-assisted therapy performed by subjects in the home setting without supervision.

  This is measured during the intervention (i.e., during the six weeks of unsupervised therapy at home).

• 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.

  This is measured during the intervention (i.e., during the six weeks of unsupervised therapy at home).

• 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.

  This is measured during the intervention (i.e., during the six weeks of unsupervised therapy at home).

Secondary Outcomes (32)

• Feasibility - Adverse events

  This is monitored over the whole protocol duration (i.e., from beginning of the first week to the end of the six weeks of unsupervised therapy at home).

• Feasibility - Device deficiencies

  This is monitored over the whole protocol duration (i.e., from beginning of the first week to the end of the six weeks of unsupervised therapy at home).

• Feasibility - Subjects performing unsupervised robot-assisted training

  This is calculated on completion of the study (i.e., right after last subject - last visit).

• Feasibility - Attendance

  This is calculated on completion of the study protocol.

• Usability as assessed by the System Usability Scale (1)

  This is measured during the intervention (at the end of the familiarization phase).

Study Arms (1)

Unsupervised therapy

EXPERIMENTAL

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).

Device: Supervised and minimally-supervised therapy with ReHandyBot; Device: Unsupervised therapy

Interventions

Supervised and minimally-supervised therapy with ReHandyBot 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.

Also known as: Familiarization phase

Unsupervised therapy

Unsupervised therapy 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.

Unsupervised therapy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead
• Clinica Hildebrand Brissago: collaborator

Study Sites (1)

Clinica Hildebrand Centro di riabiliazione Brissago

Brissago, Canton Ticino, 6614, Switzerland

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Paolo Rossi, Dr. med.

  Clinica Hildebrand Brissago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giada Devittori, M. Sc.

CONTACT

+41 44 510 72 31; giada.devittori@hest.ethz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 28, 2023
• Study Start: November 13, 2023
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)