Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
58

Summary

Conditions
  • Acute Stroke
  • Chronic Stroke
  • Stroke
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 85 years
Gender
Both males and females

Description

This multicenter non-randomized controlled trial aims: to investigate the efficacy of a treadmill-based robotic treatment (both end-effector and exoskeleton) compared to the conventional rehabilitative treatment on gait recovery in stroke survivors; to verify different effects of the end-effector or...

This multicenter non-randomized controlled trial aims: to investigate the efficacy of a treadmill-based robotic treatment (both end-effector and exoskeleton) compared to the conventional rehabilitative treatment on gait recovery in stroke survivors; to verify different effects of the end-effector or exoskeleton system on stroke subjects with different disabilities. All the eligible subjects (please, see the inclusion and exclusion criteria), admitted to the study participant centers for rehabilitation treatment, will be recorded at any stage of the rehabilitation program (subacute or chronic phase). The patient's recruitment will run following the authorization of the respective Ethics Committees for 12 months. Both experimental or control group will be undergone to 20 sessions of treatments, from 3 to 5 times per week, each lasting 60 minutes ( for a total of 400 minutes of treatment) All robotic systems used in this study for the experimental group (Lokomat Pro - Hocoma AG, Volketswil, Switzerland; G-EO System - Rehatechnologies, Italy) are treadmill-based and do not provide the over-ground gait training. They are characterized by the possibility of a programmable load suspension, as well as speed, stride length. The patient's activity with the related data is always displayed and stored with a computerized control system. The control group will follow a traditional gait rehabilitation for the same duration as the experimental group. The clinical assessments and data analysis will be carried out blindly.

Tracking Information

NCT #
NCT03688165
Collaborators
  • Fondazione Don Carlo Gnocchi Onlus
  • Ospedale Santo Stefano
  • Fondazione Centri di Riabilitazione Padre Pio Onlus
  • Habilita, Ospedale di Sarnico
  • APSS Trento
  • Azienda Sanitaria n. 4 Chiavarese
  • Azienda Ospedaliera San Gerardo di Monza
  • University Hospital of Ferrara
  • I.R.C.C.S. Fondazione Santa Lucia
  • Azienda Ospedaliero, Universitaria Pisana
  • Privatklinik Villa Melitta
  • Azienda Socio Sanitaria Territoriale di Mantova
  • Centro Ricerche Cliniche di Verona
  • Azienda Sanitaria Locale n.2 Savonese
  • Unità di Neuroriabilitazione, HABILITA
  • Istituto Piero Redaelli, Milano
  • S. Anna Hospital
Investigators
Study Chair: Marco Franceschini, MD IRCCS San Raffaele Pisana Principal Investigator: Sanaz Pournajaf, Dr IRCCS San Raffaele Pisana