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

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ClinicalTrials.gov Identifier: NCT03688165
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : March 2, 2020
Sponsor:
Collaborators:
Ospedale Santo Stefano
APSS Trento TN
Azienda Sanitaria n. 4 Chiavarese
Fondazione Don Carlo Gnocchi Onlus
Azienda Ospedaliera San Gerardo di Monza
University Hospital of Ferrara
Privatklinik Villa Melitta
Centro Ricerche Cliniche di Verona
Unità di Neuroriabilitazione, HABILITA Zingonia (BG)
Istituto Piero Redaelli, Milano
S. Anna Hospital
Azienda Sanitaria Locale n.2 Savonese
Fondazione Centri di Riabilitazione Padre Pio Onlus. San Giovanni Rotondo (FG)
Habilita, Ospedale di Sarnico
I.R.C.C.S. Fondazione Santa Lucia
Azienda Ospedaliero, Universitaria Pisana
Azienda Socio Sanitaria Territoriale di Mantova
Information provided by (Responsible Party):
Marco Franceschini, MD, IRCCS San Raffaele

Brief Summary:

This multi-site randomized controlled trial aims to investigate the effectiveness (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 subacute or chronic phase will be recorded. The experimental group will follow a set of robotic gait training by on the treadmill based robotic systems which does not provide the over ground gait training (Lokomat Pro - Hocoma AG, Volketswil, Switzerland; G-EO System - Reha technologies, Italy). While, the controll group will follow a traditional gait training composed of all those exercises which promote the recovery of walking ability (please, see the interventions details).


Condition or disease Intervention/treatment
Stroke Acute Stroke Chronic Stroke Device: Treadmill-based Robotic Gait Training

Detailed Description:

This multi-site randomized controlled trial aims to:

  • investigate the efficacy of an treadmill-based robotic treatment (both end-effector system or exoskeleton) versus the conventional rehabilitative treatment on gait recovery in stroke survivors;
  • to verify the possible different efficacy of end effector and exoskeleton systems in the various post-stroke disability pictures.

The randomization will be carry out at each center in single blind design using an a proper software.

All the eligible subjects (please, see the inclusion and exclusion criteria), admitted to the study participant centers for rehabilitation treatment, will be recorded consecutively and 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 treatmen) All robotic systems used in this study for the 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 controll group will follow a traditional gait rehabilitation for the same duration as experimental group.

The clinical assements and data analysis will be carried out blindly.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 58 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: The Effects of Gait Rehabilitation Using Treadmill-based Robotics (Exoskeletons or End-effectors) Versus Traditional Physical Therapy in Stroke Survivors: a Multi-site Randomized Controlled Trial
Actual Study Start Date : June 20, 2018
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Group/Cohort Intervention/treatment
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
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 Name: Over-ground Traditional 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.




Primary Outcome Measures :
  1. Change in 10 Meter Walk Test (10MWT) [ Time Frame: at baseline (T0), at 2 months-the end of treatment (T1) and at 3 months after the end of rehabilitation-follow up (T2) ]
    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.


Secondary Outcome Measures :
  1. Change in Timed Up and Go test (TUG) [ Time Frame: at baseline (T0), at 2 months-the end of treatment (T1) and at 3 months after the end of rehabilitation-follow up (T2) ]
    The TUG is a test used to assess mobility, balance, and walking in people with balance impairments. The subject must stand up from a chair (which should not be leant against a wall), walk a distance of 3 meters, turn around, walk back to the chair and sit down - all performed as quickly and as safely as possible. Time will be measured using a chronometer.

  2. Change in 6 Minute Walking Test (6MWT) [ Time Frame: at baseline (T0), at 2 months-the end of treatment (T1) and at 3 months after the end of rehabilitation-follow up (T2) ]
    The 6MWT measures the distance a subject covers during an indoor gait on a flat, hard surface in 6 minutes, using assistive devices, as necessary. The test is a reliable and valid evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance. The minimal detectable change in distance for people with sub-acute stroke is 60.98 meters. The 6MWT is a patient self-paced walk test and assesses the level of functional capacity. Patients are allowed to stop and rest during the test. However, the timer does not stop. If the patient is unable to complete the test, the time is stopped at that moment. The missing time and the reason of the stop are recorded. This test will be administered while wearing a pulse oximeter to monitor heart rate and oxygen saturation, also integrated with Borg scale to assess dyspnea.

  3. Change in Trunk Control Test (TCT) [ Time Frame: at baseline (T0), at 2 months-the end of treatment (T1) and at 3 months after the end of rehabilitation-follow up (T2) ]
    The TCT assesses the motor impairment in stroke patients and it's correlated with eventual walking ability. Testing is done with the patient lying on a bed: (1) roll to weak side. (2) roll to strong side. (3) balance in sitting position on the edge of the bed with the feet off the ground for at least 30. (4) sit up from lying down. Total score: 0-100.

  4. Change in Motricity Index (MI) [ Time Frame: at baseline (T0), at 2 months-the end of treatment (T1) and at 3 months after the end of rehabilitation-follow up (T2) ]

    The MI aims to evaluate lower limb motor impairment after stroke, administrated on both sides.

    Items to assess the lower limbs are 3, scoring from 0 to 33 each: (1) ankle dorsiflexion with foot in a plantar flexed position (2) knee extension with the foot unsupported and the knee at 90° (3) hip flexion with the hip at 90° moving the knee as close as possible to the chin. (no movement: 0, palpable flicker but no movement: 9, movement but not against gravity :14, movement against gravity movement against gravity: 19, movement against resistance: 25, normal:33)

    1 leg score for each side = SUM (points for the 3 leg tests) + 1 Interpretation: minimum score: 0; maximum score:100


  5. Change in ModifiedAshworth Scale (MAS) [ Time Frame: at baseline (T0), at 2 months-the end of treatment (T1) and at 3 months after the end of rehabilitation-follow up (T2) ]
    The MAS is a 6 point ordinal scale used for grading hypertonia in individuals with neurological diagnoses. A score of 0 on the scale indicates no increase in tone while a score of 4 indicates rigidity. Tone is scored by passively moving the individual's limb and assessing the amount of resistance to movement felt by the examiner.

  6. Change in Modified Barthel Index (mBI) [ Time Frame: at baseline (T0), at 2 months-the end of treatment (T1) and at 3 months after the end of rehabilitation-follow up (T2) ]
    To assess the level of disability during the indoor and outdoor activities of daily living

  7. Change in Walking Handicap Scale (WHS) [ Time Frame: at baseline (T0), at 2 months-the end of treatment (T1) and at 3 months after the end of rehabilitation-follow up (T2) ]
    WHS is a classification of 6 functional walking categories, considered as a participation category of the ICF because of its 3 items referred to community ambulation.


Other Outcome Measures:
  1. Functional Ambulation Category (FAC) [ Time Frame: at baseline (T0) only ]
    FAC is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03688165


Contacts
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Contact: Marco Franceschini, MD +39 06 522532319 marco.franceschini@sanraffaele.it
Contact: Sanaz Pournajaf, DR +39 06 522532319 sanaz.pournajaf@sanraffaele.it

Locations
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Italy
U.O.C. Medicina Fisica e Riabilitazione, osp.S.Gerardo Recruiting
Monza, Lombardia, Italy
Contact: Donatella Bonaiuti, MD       dbonaiuti2@yahoo.it   
Irccs Centro Neurolesi Bonino Pulejo Recruiting
Messina, Italy
Contact: Rocco Calabrò, PhD       roccos.calabro@irccsme.it   
Irccs Fondazione Santa Lucia Recruiting
Roma, Italy, 00100
Contact: Federica Tamburella, PhD       f.tamburella@hsantalucia.it   
Contact: Marcella Masciullo, Dr         
IRCCS San Raffaele Pisana Recruiting
Roma, Italy, I-00163
Contact: Marco Franceschini, MD    +390652252402    marco.franceschini@sanraffaele.it   
Contact: Sanaz Pournajaf, DR    +390652252319    sanaz.pournajaf@sanraffaele.it   
Sub-Investigator: Michela Goffredo, Phd         
Sponsors and Collaborators
Marco Franceschini, MD
Ospedale Santo Stefano
APSS Trento TN
Azienda Sanitaria n. 4 Chiavarese
Fondazione Don Carlo Gnocchi Onlus
Azienda Ospedaliera San Gerardo di Monza
University Hospital of Ferrara
Privatklinik Villa Melitta
Centro Ricerche Cliniche di Verona
Unità di Neuroriabilitazione, HABILITA Zingonia (BG)
Istituto Piero Redaelli, Milano
S. Anna Hospital
Azienda Sanitaria Locale n.2 Savonese
Fondazione Centri di Riabilitazione Padre Pio Onlus. San Giovanni Rotondo (FG)
Habilita, Ospedale di Sarnico
I.R.C.C.S. Fondazione Santa Lucia
Azienda Ospedaliero, Universitaria Pisana
Azienda Socio Sanitaria Territoriale di Mantova
Investigators
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Study Chair: Marco Franceschini, MD IRCCS San Raffaele Pisana
Principal Investigator: Sanaz Pournajaf, Dr IRCCS San Raffaele Pisana
Additional Information:

Publications of Results:
Other Publications:

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Responsible Party: Marco Franceschini, MD, Head of NeuroRehabilitation Research Area, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT03688165    
Other Study ID Numbers: 01/2018
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: March 2, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marco Franceschini, MD, IRCCS San Raffaele:
Stroke
End-effector
Exoskeleton
Treadmill-based gait training
Over-ground gait training
Rehabilitation
Functional Gait Recovery
Hemiparesis
Treadmill-based robotic systems
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases