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

The Effects of Gait Rehabilitation Using Treadmill-based Robotics (Exoskeletons or End-effectors) Versus Traditional Physical Therapy in Stroke Survivors: a Multicenter Controlled Non-randomized Trial

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).

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.

Inclusion Criteria:

• age ≤ 85 years;
• first ever event of pyramidal hemisyndrome (any functional level and etiology);
• possibility to understand and execute simple instructions, for performing correctly the robot exercise;
• for chronic patients: Functional Ambulation Category (FAC)> 1.

Exclusion Criteria:

• bilateral impairment;
• Walking Handicap Scale (WHS) <5 before the acute event;
• cognitive or behavioral deficit as to compromise the comprehension of the robotic training;
• neurolytic treatment with botulinum toxin in the previous 3 months and/or during the study (including follow up);
• use of other technologies (robots, FES, TDCS ...) during the study;
• impossibility or non-availability to provide the informed consent;
• cardiorespiratory gravity-morbidity