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

IRCCS San Raffaele Roma

Status: Completed

Conditions: Stroke; Chronic Stroke; Acute Stroke

Treatments: Other: Traditional Over-ground Gait Training; Device: Treadmill-based Robotic Gait Training

Study type: Observational

Funder types: Other

Identifiers

NCT03688165

RP 19/17

Details and patient eligibility

About

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).

Full 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.

Enrollment: 87 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

87 participants in 2 patient groups

Treadmill-based Robotic Gait Training

Description:

The Treadmill-based Robotic Gait Training (TRGT) period will last 20 sessions, 3-5 days/week for at least 400' of exercise totally. The parameters to be respected for the robotic training will be the following for all patients: 0.9 km / h starting speed up to a maximum of 2.5 km / h; weight support not exceeding 40-45% of the body weight at the beginning and gradual progressive reduction depending on the case; for Lokomat: maximum assistance required at the start of treatment and gradual decrease during the treatment. The TRGT will always be associated with the traditional gait rehabilitation, and will be part of the Individual Rehabilitation Project which normally includes 3 hours of rehabilitation treatments for patients in the subacute phase, 60' of treatment for those in chronic phase.

Treatment:

Device: Treadmill-based Robotic Gait Training

Traditional Over-ground Gait Training

Description:

The Traditional Over-ground Gait Training (TOGT) period will last 20 sessions, 3-5 days / week for a total time that corresponds to the same total time of traditional overground gait training, or at least 400' totally at the end of the period. By Traditional Therapy we mean any 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.

Treatment:

Other: Traditional Over-ground Gait Training