Severe StrokeNCT03805009

Efficacy of End-Effector Robot-Assisted Gait Training in Subacute Stroke Patients

A study testing Robot-Assisted Gait Training (RAGT) in people with Severe Stroke and Acute Stroke, run by IRCCS San Raffaele Roma at 2 sites in Italy.

Completed

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

Official record

Search all trials

Trial summary

To date, no studies seems to compare conventional gait rehabilitation program with end-effector RAGT in subacute stroke patients by analysing the variations of gait kinematics beyond clinical multi prospective outcomes. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Severe Stroke, Acute Stroke, Mild Stroke
What is being tested?: Robot-Assisted Gait Training (RAGT)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 2 sitesItaly
Study dates: 19 Mar 2013to 30 Sep 2018
Phase: Interventional
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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

first cerebral stroke
2 weeks up to 6 months post the acute event (subacute patients)
age between 18-80 years
ability to fit into the end-effector footplates
no significant limitation of joint range of motion
ability to tolerate upright standing for 60 seconds

Show all 9Show fewer

ability to walk unassisted or with little assistance
ability to give written consent
compliance with the study procedures

Who cannot join

contractures of the hip, knee, or ankle joints that might limit the range of motion during gait
medical issue that precludes full weight bearing and ambulation (e.g. orthopaedic injuries, pain, severe osteoporosis, or severe spasticity)
cognitive and/or communicative disability (e.g. due to brain injury): inability to understand the instructions required for the study
cardiac pathologies, anxiety or psychosis that might interfere with the use of the equipment or testing
Written informed consent was obtained from each subject.

Trial locations and contacts

2 sites in 1 country.

Italy2 sites

IRCCS San Raffaele Pisana
Rome, RM, 00163
Fondazione Don Carlo Gnocchi Onlus
Rome, RM, 00166

Other trials in Italy

About this study

Official title: Efficacy of End-Effector Robot-Assisted Gait Training in Subacute Stroke Patients: Clinical and Gait Outcomes

The aim of this pilot study is to evaluate the efficacy of end-effector RAGT in subacute stroke patients in terms of clinical outcomes and gait kinematics, comparing them with conventional gait rehabilitation program.

Read the detailed description

To evaluate the efficacy of end-effector RAGT in subacute stroke patients in terms of clinical outcomes and gait kinematics, comparing them with conventional gait rehabilitation program, patients following first ever stroke in sub-acute phase will be recruited and assessed both clinically and instrumentally (Gait Analysis) at baseline (T0) and at the end of training program (T1). The patients will be divided into 2 groups and will conduct two different types of gait training: one group will be recruited by IRCCS San Raffaele Pisana of Rome and will perform, in addition to conventional therapy, gait training using an end-effector robotic device for RAGT(Robotic Group, RG); and another group will be recruited by the Don Carlo Gnocchi Foundation Onlus of Rome, and will perform conventional gait rehabilitation program(Conventional Group, CG).

Conditions: Severe Stroke, Acute Stroke, Mild Stroke, Central Nervous System Diseases, Cerebrovascular Disease, Brain Diseases
Being tested: Robot-Assisted Gait Training (RAGT)
Keywords: Stroke, Robot, Hemiparesis, Gait Training, Rehabilitation, Functional Recovery, Robot-Assisted Gait Training
Medical subject headings: Stroke, Central Nervous System Diseases, Cerebrovascular Disorders, Brain Diseases, Cardiovascular Diseases, Gait Disorders, Neurologic, Paresis

What participants receive

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

Robot-Assisted Gait Training (RAGT)Device
The Robotic Group (RG) performs a Robot-Assisted Gait Training (RAGT) using an end-effector robotic device (G-EO system-Reha Technology-Olten, Switzerland).

Study groups in NCT03805009
Study group	Role	What they receive
Robotic Group (RG)	Experimental	Robotic Group (RG) will perform, in addition to conventional therapy, gait training using an end-effector robotic device for Robot-Assisted Gait Training (RAGT), 3 times/week for 20 sessions. During the training, patients will be asked to walk, at a varying speed, for 45 minutes and a partial Body Weight Support (BWS). Participants will start with 30-40% of BWS and an initial speed of 1.5 km/h; increasing to a maximum of between 2.2 and 2.5 km/h and reducing the initial BWS to 15%. The therapist will provide any help during sessions if required. Over 45 minutes, the patient simulates a minimum of 300 steps; patients could rest during the session, though they will be asked to walk continuously for a minimum of 5 minutes during each session. Receives: Device: Robot-Assisted Gait Training (RAGT)
Conventional Group (CG)	No intervention	Conventional Group (CG) will perform conventional gait rehabilitation program. The treatment will include: muscle strengthening exercises and stretching of the lower limb, and static and dynamic exercises for the recovery of balance in the supine and standing positions using assistive devices; training gait exercises with parallel bars or in open spaces performed both with and without assistive devices; training to climb up and down stairs; exercises to improve proprioception in the supine, sitting and standing positions, using a proprioceptive footboard; exercises to improve trunk control.

What is being measured

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

Change in Six-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: Session 1 (baseline), and Session 20 (week 7)

Secondary outcomes (10)

Change in Fugl-Meyer Assessment (FMA) scale
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. The scale is comprised of five domains and there are 155 items in total:
- Motor functioning (the score ranges from 0 (hemiplegia) to 100 points (normal motor performance). Divided into 66 points for upper extremity and 34 points for the lower extremity.
- Sensory functioning (from 0 to 24 points)
- Balance (from 0 to 14)
- Joint range of motion (from 0 to 44)
- Joint pain (from 0 to 44 ) Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible scale score is 226.
Measured: Session 1 (baseline), and Session 20 (week 7)
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)
Measured: Session 1 (baseline), and Session 20 (week 7)
Change in Modified Ashworth 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: Session 1 (baseline), and Session 20 (week 7)
Change in Tinetti Scale Balance (TIN-B)
Scales to measure activity ICF domain.
Measured: Session 1 (baseline), and Session 20 (week 7)
Change in Tinetti Walking (TIN-W)
Scales to measure activity ICF domain.
Measured: Session 1 (baseline), and Session 20 (week 7)
Change in Functional Ambulation Classification (FAC)
Functional Ambulation Classification 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.
Measured: Session 1 (baseline), and Session 20 (week 7)
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: Session 1 (baseline), and Session 20 (week 7)
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: Session 1 (baseline), and Session 20 (week 7)
Change in Time Up And Go (TUG)
The Time Up And Go 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: Session 1 (baseline), and Session 20 (week 7)
Change in Walking Handicap Scale (WHS)
The Walking Handicap Scale 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. The score ranges from 1 to 6, and do higher values represent a better outcome.
Measured: Session 1 (baseline), and Session 20 (week 7)

Timeline

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

19 Mar 201330 Sep 2018

First posted15 Jan 2019
Study start19 Mar 2013
Primary completion31 Dec 2017
Study completion30 Sep 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (23)Papers the sponsor has linked to this study.
Other trials for Severe StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Single blinded, non randomized, pilot study
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03805009
Sponsor's protocol ID: RP 15/13
Status last verified: Jun 2023
First submitted: 10 Jan 2019
Last updated: 10 Apr 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Palmieri L, Barchielli A, Cesana G, de Campora E, Goldoni CA, Spolaore P, Uguccioni M, Vancheri F, Vanuzzo D, Ciccarelli P, Giampaoli S; Research Group of the Project 'Italian National Register of Coronary and Cerebrovascular Events'. The Italian register of cardiovascular diseases: attack rates and case fatality for cerebrovascular events. Cerebrovasc Dis. 2007;24(6):530-9. doi: 10.1159/000110423. Epub 2007 Oct 29.
PubMed 17971632
Swinnen E, Beckwee D, Meeusen R, Baeyens JP, Kerckhofs E. Does robot-assisted gait rehabilitation improve balance in stroke patients? A systematic review. Top Stroke Rehabil. 2014 Mar-Apr;21(2):87-100. doi: 10.1310/tsr2102-87.
PubMed 24710969
Eng JJ, Tang PF. Gait training strategies to optimize walking ability in people with stroke: a synthesis of the evidence. Expert Rev Neurother. 2007 Oct;7(10):1417-36. doi: 10.1586/14737175.7.10.1417.
PubMed 17939776
Langhorne P, Coupar F, Pollock A. Motor recovery after stroke: a systematic review. Lancet Neurol. 2009 Aug;8(8):741-54. doi: 10.1016/S1474-4422(09)70150-4.
PubMed 19608100
Mehrholz J, Thomas S, Werner C, Kugler J, Pohl M, Elsner B. Electromechanical-assisted training for walking after stroke. Cochrane Database Syst Rev. 2017 May 10;5(5):CD006185. doi: 10.1002/14651858.CD006185.pub4.
PubMed 28488268
Pons, J. L. (2008). Wearable robots: biomechatronic exoskeletons. John Wiley & Sons. 127-164.
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
Mehrholz J, Pohl M. Electromechanical-assisted gait training after stroke: a systematic review comparing end-effector and exoskeleton devices. J Rehabil Med. 2012 Mar;44(3):193-9. doi: 10.2340/16501977-0943.
PubMed 22378603
Kelley CP, Childress J, Boake C, Noser EA. Over-ground and robotic-assisted locomotor training in adults with chronic stroke: a blinded randomized clinical trial. Disabil Rehabil Assist Technol. 2013 Mar;8(2):161-8. doi: 10.3109/17483107.2012.714052. Epub 2012 Sep 20.
PubMed 22992166
Cho DY, Park SW, Lee MJ, Park DS, Kim EJ. Effects of robot-assisted gait training on the balance and gait of chronic stroke patients: focus on dependent ambulators. J Phys Ther Sci. 2015 Oct;27(10):3053-7. doi: 10.1589/jpts.27.3053. Epub 2015 Oct 30.
PubMed 26644642
Li L, Ding L, Chen N, Mao Y, Huang D, Li L. Improved walking ability with wearable robot-assisted training in patients suffering chronic stroke. Biomed Mater Eng. 2015;26 Suppl 1:S329-40. doi: 10.3233/BME-151320.
PubMed 26406020
Bonnyaud C, Pradon D, Boudarham J, Robertson J, Vuillerme N, Roche N. Effects of gait training using a robotic constraint (Lokomat(R)) on gait kinematics and kinetics in chronic stroke patients. J Rehabil Med. 2014 Feb;46(2):132-8. doi: 10.2340/16501977-1248.
PubMed 24162795
Lonini L, Shawen N, Scanlan K, Rymer WZ, Kording KP, Jayaraman A. Accelerometry-enabled measurement of walking performance with a robotic exoskeleton: a pilot study. J Neuroeng Rehabil. 2016 Mar 31;13:35. doi: 10.1186/s12984-016-0142-9.
PubMed 27037035
Gandolfi M, Geroin C, Picelli A, Munari D, Waldner A, Tamburin S, Marchioretto F, Smania N. Robot-assisted vs. sensory integration training in treating gait and balance dysfunctions in patients with multiple sclerosis: a randomized controlled trial. Front Hum Neurosci. 2014 May 22;8:318. doi: 10.3389/fnhum.2014.00318. eCollection 2014.
PubMed 24904361
Sale P, Russo EF, Russo M, Masiero S, Piccione F, Calabro RS, Filoni S. Effects on mobility training and de-adaptations in subjects with Spinal Cord Injury due to a Wearable Robot: a preliminary report. BMC Neurol. 2016 Jan 28;16:12. doi: 10.1186/s12883-016-0536-0.
PubMed 26818847

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Severe Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of End-Effector Robot-Assisted Gait Training in Subacute Stroke Patients: Clinical and Gait Outcomes
ClinicalTrials.gov ID: NCT03805009
Acronym / sponsor ID: RP 15/13
Conditions: Severe Stroke, Acute Stroke, Mild Stroke, Central Nervous System Diseases, Cerebrovascular Disease, Brain Diseases
Keywords: Stroke, Robot, Hemiparesis, Gait Training, Rehabilitation, Functional Recovery, Robot-Assisted Gait Training
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: IRCCS San Raffaele RomaUniversity, hospital or other
Collaborators: Fondazione Don Carlo Gnocchi ETS
Study start: 19 Mar 2013 (actual)
Primary completion: 31 Dec 2017 (actual)
Study completion: 30 Sep 2018 (actual)
First posted: 15 Jan 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Single blinded, non randomized, pilot study

Arm	Type	Receives
Robotic Group (RG)	Experimental	Device: Robot-Assisted Gait Training (RAGT)Robotic Group (RG) will perform, in addition to conventional therapy, gait training using an end-effector robotic device for Robot-Assisted Gait Training (RAGT), 3 times/week for 20 sessions. During the training, patients will be asked to walk, at a varying speed, for 45 minutes and a partial Body Weight Support (BWS). Participants will start with 30-40% of BWS and an initial speed of 1.5 km/h; increasing to a maximum of between 2.2 and 2.5 km/h and reducing the initial BWS to 15%. The therapist will provide any help during sessions if required. Over 45 minutes, the patient simulates a minimum of 300 steps; patients could rest during the session, though they will be asked to walk continuously for a minimum of 5 minutes during each session.
Conventional Group (CG)	No intervention	–Conventional Group (CG) will perform conventional gait rehabilitation program. The treatment will include: muscle strengthening exercises and stretching of the lower limb, and static and dynamic exercises for the recovery of balance in the supine and standing positions using assistive devices; training gait exercises with parallel bars or in open spaces performed both with and without assistive devices; training to climb up and down stairs; exercises to improve proprioception in the supine, sitting and standing positions, using a proprioceptive footboard; exercises to improve trunk control.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

first cerebral stroke
2 weeks up to 6 months post the acute event (subacute patients)
age between 18-80 years
ability to fit into the end-effector footplates
no significant limitation of joint range of motion

Key exclusion criteria (5 listed)

contractures of the hip, knee, or ankle joints that might limit the range of motion during gait
medical issue that precludes full weight bearing and ambulation (e.g. orthopaedic injuries, pain, severe osteoporosis, or severe spasticity)
cognitive and/or communicative disability (e.g. due to brain injury): inability to understand the instructions required for the study
cardiac pathologies, anxiety or psychosis that might interfere with the use of the equipment or testing
Written informed consent was obtained from each subject.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Robot-Assisted Gait Training (RAGT)The Robotic Group (RG) performs a Robot-Assisted Gait Training (RAGT) using an end-effector robotic device (G-EO system-Reha Technology-Olten, Switzerland).	Device	Robotic Group (RG)

Primary outcome

Change in Six-Minute Walking Test (6MWT)
Time frame: Session 1 (baseline), and Session 20 (week 7)
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.

10 secondary outcomes

Change in Fugl-Meyer Assessment (FMA) scale
Time frame: Session 1 (baseline), and Session 20 (week 7)
Change in Motricity Index (MI)
Time frame: Session 1 (baseline), and Session 20 (week 7)
Change in Modified Ashworth Scale (MAS)
Time frame: Session 1 (baseline), and Session 20 (week 7)
Change in Tinetti Scale Balance (TIN-B)
Time frame: Session 1 (baseline), and Session 20 (week 7)
Change in Tinetti Walking (TIN-W)
Time frame: Session 1 (baseline), and Session 20 (week 7)
Change in Functional Ambulation Classification (FAC)
Time frame: Session 1 (baseline), and Session 20 (week 7)
Change in Trunk Control Test (TCT)
Time frame: Session 1 (baseline), and Session 20 (week 7)
Change in 10 Meter Walk Test (10MWT)
Time frame: Session 1 (baseline), and Session 20 (week 7)
Change in Time Up And Go (TUG)
Time frame: Session 1 (baseline), and Session 20 (week 7)
Change in Walking Handicap Scale (WHS)
Time frame: Session 1 (baseline), and Session 20 (week 7)

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
Background: PubMed 17971632Palmieri L, Barchielli A, Cesana G, de Campora E, Goldoni CA, Spolaore P, Uguccioni M, Vancheri F, Vanuzzo D, Ciccarelli P, Giampaoli S; Research Group of the Project 'Italian National Register of Coronary and Cerebrovascular Events'. The Italian register of cardiovascular diseases: attack rates and case fatality for cerebrovascular events. Cerebrovasc Dis. 2007;24(6):530-9. doi: 10.1159/000110423. Epub 2007 Oct 29.
Background: PubMed 24710969Swinnen E, Beckwee D, Meeusen R, Baeyens JP, Kerckhofs E. Does robot-assisted gait rehabilitation improve balance in stroke patients? A systematic review. Top Stroke Rehabil. 2014 Mar-Apr;21(2):87-100. doi: 10.1310/tsr2102-87.
Background: PubMed 17939776Eng JJ, Tang PF. Gait training strategies to optimize walking ability in people with stroke: a synthesis of the evidence. Expert Rev Neurother. 2007 Oct;7(10):1417-36. doi: 10.1586/14737175.7.10.1417.
Background: PubMed 19608100Langhorne P, Coupar F, Pollock A. Motor recovery after stroke: a systematic review. Lancet Neurol. 2009 Aug;8(8):741-54. doi: 10.1016/S1474-4422(09)70150-4.
Background: PubMed 28488268Mehrholz J, Thomas S, Werner C, Kugler J, Pohl M, Elsner B. Electromechanical-assisted training for walking after stroke. Cochrane Database Syst Rev. 2017 May 10;5(5):CD006185. doi: 10.1002/14651858.CD006185.pub4.
BackgroundPons, J. L. (2008). Wearable robots: biomechatronic exoskeletons. John Wiley & Sons. 127-164.
Background: PubMed 20584307Hesse 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.
Background: PubMed 22378603Mehrholz J, Pohl M. Electromechanical-assisted gait training after stroke: a systematic review comparing end-effector and exoskeleton devices. J Rehabil Med. 2012 Mar;44(3):193-9. doi: 10.2340/16501977-0943.
Background: PubMed 22992166Kelley CP, Childress J, Boake C, Noser EA. Over-ground and robotic-assisted locomotor training in adults with chronic stroke: a blinded randomized clinical trial. Disabil Rehabil Assist Technol. 2013 Mar;8(2):161-8. doi: 10.3109/17483107.2012.714052. Epub 2012 Sep 20.
Background: PubMed 26644642Cho DY, Park SW, Lee MJ, Park DS, Kim EJ. Effects of robot-assisted gait training on the balance and gait of chronic stroke patients: focus on dependent ambulators. J Phys Ther Sci. 2015 Oct;27(10):3053-7. doi: 10.1589/jpts.27.3053. Epub 2015 Oct 30.
Background: PubMed 26406020Li L, Ding L, Chen N, Mao Y, Huang D, Li L. Improved walking ability with wearable robot-assisted training in patients suffering chronic stroke. Biomed Mater Eng. 2015;26 Suppl 1:S329-40. doi: 10.3233/BME-151320.
Background: PubMed 24162795Bonnyaud C, Pradon D, Boudarham J, Robertson J, Vuillerme N, Roche N. Effects of gait training using a robotic constraint (Lokomat(R)) on gait kinematics and kinetics in chronic stroke patients. J Rehabil Med. 2014 Feb;46(2):132-8. doi: 10.2340/16501977-1248.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marco Franceschini, MD study chair

IRCCS San Raffaele Pisana

Sanaz Pournajaf, Dr principal investigator

IRCCS San Raffaele Pisana

Michela Goffredo, Ing principal investigator

IRCCS San Raffaele Pisana

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Robot-Assisted Gait Training (RAGT) in people with Severe Stroke and Acute Stroke, run by IRCCS San Raffaele Roma at 2 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 9 inclusion and 5 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 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 Six-Minute Walking Test (6MWT) (time frame: Session 1 (baseline), and Session 20 (week 7)). 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 NCT03805009, which also lists 23 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 10 Apr 2024.