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StrokeTREAD_STROKENCT03688165

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

An observational study of Stroke and Acute Stroke, run by IRCCS San Raffaele Roma at 4 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Stroke, Acute Stroke, Chronic Stroke
What is being tested?
Treadmill-based Robotic Gait Training and Traditional Over-ground Gait Training
Type of treatment
Medical device
How many people
87 participants
Where
4 sitesItaly
Study dates
20 Jun 2018to 30 Jul 2022
How long will I take part?
3 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: All the subjects admitted to the participating centers for rehabilitation treatment following a first ever stroke, both in subacute or chronic phase.

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

4 sites in 1 country.

Italy4 sites

  • Irccs Centro Neurolesi Bonino Pulejo

    Messina

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

    Monza, Lombardy

  • IRCCS San Raffaele Pisana

    Roma, Italy, I-00163

  • Irccs Fondazione Santa Lucia

    Roma, 00100

Other trials in Italy

About this study

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

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).

Read the 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.

Being tested
Treadmill-based Robotic Gait Training, Traditional Over-ground Gait Training
Keywords
Stroke, End-effector, Exoskeleton, Treadmill-based gait training, Over-ground gait training, Rehabilitation, Functional Gait Recovery, Hemiparesis, Treadmill-based robotic systems
Medical subject headings
Stroke, Paresis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Treadmill-based Robotic Gait TrainingDevice

    Also called Over-ground Traditional 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.

  • Traditional Over-ground Gait TrainingOther

    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.

Study groups in NCT03688165
Study groupRoleWhat they receive
Treadmill-based Robotic Gait TrainingThe 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.
Receives: Device: Treadmill-based Robotic Gait Training
Traditional Over-ground Gait TrainingThe 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.
Receives: Other: Traditional Over-ground Gait Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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

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

  5. 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.

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

  6. Change in Modified Barthel Index (mBI)

    To assess the level of disability during the indoor and outdoor activities of daily living

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

  7. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2018
  2. Study start20 Jun 2018
  3. Primary completion30 Jun 2022
  4. Study completion30 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
87 participants (actual)
Target duration
3 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT03688165
Sponsor's protocol ID
RP 19/17
Acronym
TREAD_STROKE
Status last verified
Mar 2025
First submitted
26 Sep 2018
Last updated
2 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) related to primary and secondary outcome measures, including assessment results and relevant demographic data, can be shared in compliance with ethical and legal requirements upon specific request to the Study PI.

Publications

  • Bae YH, Ko YJ, Chang WH, Lee JH, Lee KB, Park YJ, Ha HG, Kim YH. Effects of Robot-assisted Gait Training Combined with Functional Electrical Stimulation on Recovery of Locomotor Mobility in Chronic Stroke Patients: A Randomized Controlled Trial. J Phys Ther Sci. 2014 Dec;26(12):1949-53. doi: 10.1589/jpts.26.1949. Epub 2014 Dec 25.

    PubMed 25540505

  • Balami JS, Buchan AM. Complications of intracerebral haemorrhage. Lancet Neurol. 2012 Jan;11(1):101-18. doi: 10.1016/S1474-4422(11)70264-2.

    PubMed 22172625

  • Bejot Y, Daubail B, Giroud M. Epidemiology of stroke and transient ischemic attacks: Current knowledge and perspectives. Rev Neurol (Paris). 2016 Jan;172(1):59-68. doi: 10.1016/j.neurol.2015.07.013. Epub 2015 Dec 21.

    PubMed 26718592

  • Blackburn M, van Vliet P, Mockett SP. Reliability of measurements obtained with the modified Ashworth scale in the lower extremities of people with stroke. Phys Ther. 2002 Jan;82(1):25-34. doi: 10.1093/ptj/82.1.25.

    PubMed 11784275

  • Bohannon RW, Andrews AW, Glenney SS. Minimal clinically important difference for comfortable speed as a measure of gait performance in patients undergoing inpatient rehabilitation after stroke. J Phys Ther Sci. 2013 Oct;25(10):1223-5. doi: 10.1589/jpts.25.1223. Epub 2013 Nov 20.

    PubMed 24259762

  • Bowden MG, Balasubramanian CK, Behrman AL, Kautz SA. Validation of a speed-based classification system using quantitative measures of walking performance poststroke. Neurorehabil Neural Repair. 2008 Nov-Dec;22(6):672-5. doi: 10.1177/1545968308318837.

    PubMed 18971382

  • Chang WH, Kim YH. Robot-assisted Therapy in Stroke Rehabilitation. J Stroke. 2013 Sep;15(3):174-81. doi: 10.5853/jos.2013.15.3.174. Epub 2013 Sep 27.

    PubMed 24396811

  • Chollet F, Albucher JF. Strategies to augment recovery after stroke. Curr Treat Options Neurol. 2012 Dec;14(6):531-40. doi: 10.1007/s11940-012-0196-3.

    PubMed 22865294

  • Danzl MM, Chelette KC, Lee K, Lykins D, Sawaki L. Brain stimulation paired with novel locomotor training with robotic gait orthosis in chronic stroke: a feasibility study. NeuroRehabilitation. 2013;33(1):67-76. doi: 10.3233/NRE-130929.

    PubMed 23949035

  • Demeurisse G, Demol O, Robaye E. Motor evaluation in vascular hemiplegia. Eur Neurol. 1980;19(6):382-9. doi: 10.1159/000115178.

    PubMed 7439211

  • Dobkin BH. Clinical practice. Rehabilitation after stroke. N Engl J Med. 2005 Apr 21;352(16):1677-84. doi: 10.1056/NEJMcp043511.

    PubMed 15843670

  • Fulk GD, Echternach JL. Test-retest reliability and minimal detectable change of gait speed in individuals undergoing rehabilitation after stroke. J Neurol Phys Ther. 2008 Mar;32(1):8-13. doi: 10.1097/NPT0b013e31816593c0.

    PubMed 18463550

  • Hesse S, Uhlenbrock D, Werner C, Bardeleben A. A mechanized gait trainer for restoring gait in nonambulatory subjects. Arch Phys Med Rehabil. 2000 Sep;81(9):1158-61. doi: 10.1053/apmr.2000.6280.

    PubMed 10987154

  • Hesse S, Waldner A, Tomelleri C. Innovative gait robot for the repetitive practice of floor walking and stair climbing up and down in stroke patients. J Neuroeng Rehabil. 2010 Jun 28;7:30. doi: 10.1186/1743-0003-7-30.

    PubMed 20584307

  • Hesse S, Schattat N, Mehrholz J, Werner C. Evidence of end-effector based gait machines in gait rehabilitation after CNS lesion. NeuroRehabilitation. 2013;33(1):77-84. doi: 10.3233/NRE-130930.

    PubMed 23949037

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke and Acute Stroke, run by IRCCS San Raffaele Roma at 4 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03688165, which also lists 47 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.

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