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

NCT03688165 | Completed DMC

• 1 other identifier: RP 19/17
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 4

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).

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

Outcome Measures

Primary Outcomes (1)

• Change in 10 Meter Walk Test (10MWT)

  This test will assess the patient's speed during gait. Patients will be asked to walk at their preferred maximum and safe speed. Patients will be positioned 1 meter before the start line and instructed to walk 10 meters, and pass the end line approximately 1 meter after. The distance before and after the course are meant to minimize the effect of acceleration and deceleration. Time will be measured using a stopwatch and recorded to the one hundredth of a second (ex: 2.15 s). The test will be recorded 3 times, with adequate rests between them. The average of the 3 times should be recorded.

  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 (7)

• Change in Timed Up and Go test (TUG)

  at baseline (T0), at 2 months-the end of treatment (T1) and at 3 months after the end of rehabilitation-follow up (T2)

• Change in 6 Minute Walking Test (6MWT)

  at baseline (T0), at 2 months-the end of treatment (T1) and at 3 months after the end of rehabilitation-follow up (T2)

• Change in Trunk Control Test (TCT)

  at baseline (T0), at 2 months-the end of treatment (T1) and at 3 months after the end of rehabilitation-follow up (T2)

• Change in Motricity Index (MI)

  at baseline (T0), at 2 months-the end of treatment (T1) and at 3 months after the end of rehabilitation-follow up (T2)

• Change in ModifiedAshworth Scale (MAS)

  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 (1)

• Functional Ambulation Category (FAC)

  at baseline (T0) only

Study Arms (2)

Treadmill-based Robotic Gait Training

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.

Device: Treadmill-based Robotic Gait Training

Traditional Over-ground Gait Training

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.

Other: Traditional Over-ground Gait Training

Interventions

Treadmill-based Robotic Gait Training DEVICE

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.

Also known as: Over-ground Traditional Gait Training

Treadmill-based Robotic Gait Training

Traditional Over-ground Gait Training OTHER

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.

Traditional Over-ground Gait Training

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS San Raffaele Roma: lead
• Ospedale Santo Stefano: collaborator
• APSS Trento: collaborator
• Azienda Sanitaria n. 4 Chiavarese: collaborator
• Fondazione Don Carlo Gnocchi Onlus: collaborator
• Azienda Ospedaliera San Gerardo di Monza: collaborator
• University Hospital of Ferrara: collaborator
• Privatklinik Villa Melitta: collaborator
• Centro Ricerche Cliniche di Verona: collaborator
• Unità di Neuroriabilitazione, HABILITA: collaborator
• Istituto Piero Redaelli, Milano: collaborator
• S. Anna Hospital: collaborator
• Azienda Sanitaria Locale n.2 Savonese: collaborator
• Fondazione Centri di Riabilitazione Padre Pio Onlus: collaborator
• Habilita, Ospedale di Sarnico: collaborator
• I.R.C.C.S. Fondazione Santa Lucia: collaborator
• Azienda Ospedaliero, Universitaria Pisana: collaborator
• Azienda Socio Sanitaria Territoriale di Mantova: collaborator

Study Sites (4)

IRCCS San Raffaele Pisana

Roma, Italy, I-00163, Italy

Location

U.O.C. Medicina Fisica e Riabilitazione, osp.S.Gerardo

Monza, Lombardy, Italy

Location

Irccs Centro Neurolesi Bonino Pulejo

Messina, Italy

Location

Irccs Fondazione Santa Lucia

Roma, 00100, Italy

Location

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MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marco Franceschini, MD

  IRCCS San Raffaele Pisana

  STUDY CHAIR

• Sanaz Pournajaf, Dr

  IRCCS San Raffaele Pisana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: September 28, 2018
• Study Start: June 20, 2018
• Primary Completion: June 30, 2022
• Study Completion: July 30, 2022
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: IPD and supporting information are available upon request starting from the official publication date and will remain accessible for a period of two years after study completion.
• Access Criteria: Access will be granted upon specific request to the Principal Investigator, Study Chair, or designated central study contact. Researchers must submit a formal proposal outlining the intended use of the data, which will be reviewed for scientific merit and ethical compliance. Approved requests will receive access through a secure data-sharing platform.

Locations

IT (4)