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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Stroke, Acute Stroke, Chronic Stroke

Intervention / Treatment
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* Device: Treadmill-based Robotic Gait Training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treadmill-based Robotic Gait Training<br>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<br>* 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.<br>* Other names: Over-ground Traditional Gait Training;|
| Traditional Over-ground Gait Training<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Timed Up and Go test (TUG) | 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. | 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) | 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. | 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) | 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. | 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) | 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 | 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) | 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. | 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 Modified Barthel Index (mBI) | To assess the level of disability during the indoor and outdoor activities of daily living | 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 Walking Handicap Scale (WHS) | 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. | at baseline (T0), at 2 months-the end of treatment (T1) and at 3 months after the end of rehabilitation-follow up (T2) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, End-effector, Exoskeleton, Treadmill-based gait training, Over-ground gait training, Rehabilitation, Functional Gait Recovery, Hemiparesis, Treadmill-based robotic systems