Robotic Telerehabilitation of the Upper Limb in Stroke — TELEREHAB  

Stroke Clinical Trial

Official title: Robotic Telerehabilitation: Feasibility of a Robotic Treatment of the Upper Limb With Remote Supervision in Patients With Stroke

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Stroke

• NCT number: NCT05250934
• Study type: Interventional
• Source: Fondazione Don Carlo Gnocchi Onlus
• Status: Completed
• Phase: N/A
• Start date: May 12, 2021
• Completion date: August 8, 2021