Robotic Telerehabilitation of the Upper Limb in Stroke (TELEREHAB)

Don Carlo Gnocchi Onlus Foundation

Status: Completed

Conditions: Stroke

Treatments: Device: Robotic rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT05250934

FDG-Telerehab2021

Details and patient eligibility

About

The goal of the study is to investigate the feasibility and the effects of a home-based upper-limb rehabilitation treatment (based on teleconsulting, telemonitoring, and robotic telerehabilitation using the robot Icone and integrated sensors) in patients with stroke.

Full description

Stroke is the second leading cause of death, the third leading cause of disability in the world and the leading cause of disability in the elderly. Rehabilitation treatment is a long and costly process, the effectiveness of which is supported by strong scientific evidence. In recent years, technology has spread to the rehabilitation field and, to date, the use of rehabilitation robotics, in addition to conventional treatment, is recommended by some stroke guidelines. The coronavirus pandemic has required a reorganization of rehabilitation services, but also an enhancement of technology as a tool in the rehabilitation field that can allow treatment in compliance with social distancing. Many scientific works have in fact confirmed the usefulness of these approaches to overcome the limits imposed by the pandemic, in particular for the treatment of disabilities in stroke patients.

The rehabilitation robot Icone (CE marked medical device, Class II-A, produced by Heaxel), is a device with certification for home use and therefore suitable for telerehabilitation. The proposed study aims to test the feasibility of rehabilitation treatment in a home setting based on a system of telecounseling, telemonitoring and robotic telerehabilitation using the robot Icone and integrated sensors for patients with stroke, to overcome the limits imposed by the COVID-19 pandemic.

Patients undergo robotic telerehabilitation treatment, carried out at home. The patient is supervised by a caregiver and, remotely, by a multidisciplinary team thanks to the use of webcams and sensors embedded in the robot. The evaluations, through clinical scales and instrumental evaluations, are carried out both in presence (at the enrollment and the end of the study) and remotely (before the first telerobotic rehabilitation session, in the middle and after the last telerobotic rehabilitation session). The study is included in the Regional Smart Specialization Strategy (S3 - Biorobotics for rehabilitation) for business & life continuity and co-financed by the European Union through LazioInnova

Enrollment: 20 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ischemic or hemorrhagic stroke (verified by MRI or CT);
• time since stroke onset > 3 months
• cognitive abilities adequate to understand the experiments and the follow instructions
• upper limb impairment (Fugl-Meyer Assessment - upper extremity score ≤58);
• presence of a caregiver to supervise the treatment

Exclusion criteria

• fixed contractions in the affected limb (ankylosis, Modified Ashworth Scale equal to 4);
• inability to understand the instructions required for the study;
• behavioral disorders that may influence therapeutic activity;
• other orthopedic or neurological diseases
• inability or unwillingness to provide informed consent.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Robotic group

Experimental group

Description:

In the robotic group, each patient undergoes 20 upper limb robotic telerehabilitation sessions, each session lasting 1 hour. The frequency is 5 sessions/week. Each session is performed at the patient's home, with direct supervision of a caregiver and remote supervision of a physical therapist, using three webcams able to show (a) the frontal and (b) the sagittal plane of the patient, as well as (c) the monitor of the robot.

Treatment:

Device: Robotic rehabilitation