The Effects of Gait Rehabilitation After Stroke by Treadmill-based Robotics Versus Traditional Gait Training

Summary

This multicenter non-randomized controlled trial aims to investigate the effectiveness (an increase of the walking speed in the 10 Meter Walk Test - 10MWT) of the robotic treatment with exoskeleton or end-effector system compared to the conventional rehabilitative treatment for the gait recovery after stroke, and to compare the possible different efficacy of end-effector and exoskeleton systems in the various post-stroke disability frameworks.

All the eligible subjects admitted to rehabilitation centers, both in the subacute phase will be recorded. The experimental group will follow a set of robotic gait training on stationary robotic systems which do not provide overground gait training (Lokomat Pro - Hocoma AG, Volketswil, Switzerland; G-EO System - Reha technologies, Italy). While, the control group will follow traditional gait training composed of all those exercises which promote the recovery of walking ability (please, see the details of the interventions).

Conditions

• Stroke
• Acute Stroke
• Chronic Stroke

Interventions

DEVICE

Treadmill-based Robotic Gait Training

All the stroke survivors admitted to the participating centers and eligible for the study will follow a gait training protocol (treadmill-based or overground). The data will be registered at baseline (T0), end of treatment (T1) and at three months follow up (T2). All robotic systems used for the study (Lokomat Pro - Hocoma AG, Volketswil, Switzerland); G-EO System - Reha technologies, Italy) are treadmill-based and do not provide the over-ground gait training. They are characterized by the possibility of a programmable weight support, as well as speed and stride length. The data relating to the patients' training is always displayed and stored with a computerized control system.

OTHER

Traditional Over-ground Gait Training

Traditional treatment for gait training consists in any conventional technical approach aimed at achieving control of the postural passages from sitting upright, of load transfer in laterality and antero-posterior in orthostatism and reorganization of the step up to the assisted path to the parallels and then with various aids.

Sponsors & Collaborators

• Ospedale Santo Stefano

  collaborator OTHER

• APSS Trento

  collaborator UNKNOWN

• Azienda Sanitaria n. 4 Chiavarese

  collaborator OTHER

• Fondazione Don Carlo Gnocchi Onlus

  collaborator OTHER

• Azienda Ospedaliera San Gerardo di Monza

  collaborator OTHER

• University Hospital of Ferrara

  collaborator OTHER

• Privatklinik Villa Melitta

  collaborator OTHER

• Centro Ricerche Cliniche di Verona

  collaborator OTHER

• Unità di Neuroriabilitazione, HABILITA

  collaborator UNKNOWN

• Istituto Piero Redaelli, Milano

  collaborator UNKNOWN

• S. Anna Hospital

  collaborator OTHER

• Azienda Sanitaria Locale n.2 Savonese

  collaborator OTHER

• Fondazione Centri di Riabilitazione Padre Pio Onlus

  collaborator UNKNOWN

• Habilita, Ospedale di Sarnico

  collaborator OTHER

• I.R.C.C.S. Fondazione Santa Lucia

  collaborator OTHER

• Azienda Ospedaliero, Universitaria Pisana

  collaborator OTHER

• Azienda Socio Sanitaria Territoriale di Mantova

  collaborator OTHER

• IRCCS San Raffaele Roma

  lead OTHER

Principal Investigators

• Marco Franceschini, MD · IRCCS San Raffaele Pisana

• Sanaz Pournajaf, Dr · IRCCS San Raffaele Pisana

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-06-20

Primary Completion

2022-06-30

Completion

2022-07-30

Countries

• Italy

Study Locations