Clinical trial NCT03688165: The Effects of Gait Rehabilitation After Stroke by Treadmill-based Robotics Versus Traditional Gait Training
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Acute Stroke
Chronic Stroke
Keywords: Stroke
End-effector
Exoskeleton
Treadmill-based gait training
Over-ground gait training
Rehabilitation
Functional Gait Recovery
Hemiparesis
Treadmill-based robotic systems
Lead sponsor: IRCCS San Raffaele Roma
Sponsor class: OTHER
Collaborators: name: Ospedale Santo Stefano
name: APSS Trento
name: Azienda Sanitaria n. 4 Chiavarese
name: Fondazione Don Carlo Gnocchi Onlus
name: Azienda Ospedaliera San Gerardo di Monza
name: University Hospital of Ferrara
name: Privatklinik Villa Melitta
name: Centro Ricerche Cliniche di Verona
name: Unità di Neuroriabilitazione, HABILITA
name: Istituto Piero Redaelli, Milano
name: S. Anna Hospital
name: Azienda Sanitaria Locale n.2 Savonese
name: Fondazione Centri di Riabilitazione Padre Pio Onlus
name: Habilita, Ospedale di Sarnico
name: I.R.C.C.S. Fondazione Santa Lucia
name: Azienda Ospedaliero, Universitaria Pisana
name: Azienda Socio Sanitaria Territoriale di Mantova
First posted: 2018-09-28
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
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.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in 10 Meter Walk Test (10MWT)
timeFrame: at baseline (T0), at 2 months-the end of treatment (T1) and at 3 months after the end of rehabilitation-follow up (T2)
Secondary outcomes:
measure: Change in Timed Up and Go test (TUG)
timeFrame: at baseline (T0), at 2 months-the end of treatment (T1) and at 3 months after the end of rehabilitation-follow up (T2)
measure: Change in 6 Minute Walking Test (6MWT)
timeFrame: at baseline (T0), at 2 months-the end of treatment (T1) and at 3 months after the end of rehabilitation-follow up (T2)
measure: Change in Trunk Control Test (TCT)
timeFrame: at baseline (T0), at 2 months-the end of treatment (T1) and at 3 months after the end of rehabilitation-follow up (T2)
measure: Change in Motricity Index (MI)
timeFrame: at baseline (T0), at 2 months-the end of treatment (T1) and at 3 months after the end of rehabilitation-follow up (T2)
measure: Change in ModifiedAshworth Scale (MAS)
timeFrame: at baseline (T0), at 2 months-the end of treatment (T1) and at 3 months after the end of rehabilitation-follow up (T2)
measure: Change in Modified Barthel Index (mBI)
timeFrame: at baseline (T0), at 2 months-the end of treatment (T1) and at 3 months after the end of rehabilitation-follow up (T2)
measure: Change in Walking Handicap Scale (WHS)
timeFrame: at baseline (T0), at 2 months-the end of treatment (T1) and at 3 months after the end of rehabilitation-follow up (T2)
Other outcomes:
measure: Functional Ambulation Category (FAC)
timeFrame: at baseline (T0) only
Locations:
city: Monza
country: Italy
facility: U.O.C. Medicina Fisica e Riabilitazione, osp.S.Gerardo
state: Lombardia
city: Messina
country: Italy
facility: Irccs Centro Neurolesi Bonino Pulejo
city: Roma
country: Italy
facility: Irccs Fondazione Santa Lucia
city: Roma
country: Italy
facility: IRCCS San Raffaele Pisana
Study officials:
affiliation: IRCCS San Raffaele Pisana
name: Marco Franceschini, MD
role: STUDY_CHAIR
affiliation: IRCCS San Raffaele Pisana
name: Sanaz Pournajaf, Dr
role: PRINCIPAL_INVESTIGATOR
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