The Effects of Gait Rehabilitation After Stroke by Treadmill-based Robotics Versus Traditional Gait Training
Condition: Stroke; Acute Stroke; Chronic Stroke
MeSH terms: Stroke
Study type: Observational [Patient Registry]

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).
    

Detailed 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 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.
    

Intervention name(s): Treadmill-based Robotic Gait Training
Intervention type(s): Device
Intervention description(s): 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 intervention name(s): Over-ground Traditional Gait Training
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All the subjects admitted to the participating centers for rehabilitation treatment
        following a first ever stroke, both in subacute or chronic phase.
      
Keywords: Stroke; End-effector; Exoskeleton; Treadmill-based gait training; Over-ground gait training; Rehabilitation; Functional Gait Recovery; Hemiparesis; Treadmill-based robotic systems