Robotic Telerehabilitation of the Upper Limb in Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

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.
    

Detailed 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
    

Intervention name(s): Robotic rehabilitation
Intervention type(s): Device
Intervention description(s): The upper limb rehabilitation will be carried out with the planar rehabilitation robot Icone (a CE Class IIA medical device manufactured by Heaxel). The proposed exercises require the patient to move a cursor on the screen using the end-effector of the robot to reach specific points (planar reaching exercises). When the patient is able to perform these exercises independently, the robot assists the movement by minimizing the interaction force applied to the hand and limiting itself to acquiring the kinematic and dynamic parameters of the exercise, which are useful in determining the state of motor skills. Icone assist the subject by applying a force to his hand that helps him complete the task in the phases where the patient plans the movement correctly but is unable to complete it. As a result, the system will enable you to perform planar elbow and shoulder movements in active, passive, or active-assisted modes, with visual and acoustic feedback.
Other intervention name(s): Icone (Heaxel)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Robotic rehabilitation; Telerehabilitation; Upper extremity