StrokeGAITGONCT04559724

Gait Training Through a Novel Over-ground Wearable Robotic System in People With Pyramidal Hemisyndromes

A study testing Indego Therapy in people with Stroke and Brain Injuries, Traumatic, run by IRCCS San Raffaele Roma at 1 site in Italy.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Over-ground exoskeletons for gait rehabilitation are studied enough in people suffering spinal cord injury, and its clinical use is escalating in the industrialized countries. Nevertheless, studies on gait rehabilitation through exoskeletons in subjects with Pyramidal Hemisyndrome (PH) are recognized by GRADE as Low… Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Stroke, Brain Injuries, Traumatic, Brain Tumor Benign
What is being tested?: Indego Therapy
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteItaly
Study dates: 1 Sep 2020to Dec 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

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

Single or multiple unilateral Cerebral Stroke
Mild / moderate Traumatic Brain Injury
Brain Tumor Benign
Possibility to keep the upright position for at least 1 minute with good cardiovascular compensation and:
With double support and supervision;
With double support without supervision;

Show all 10Show fewer

With single support and supervision;
With single support without supervision;
With assistance not exceeding 50%;
With supervision only.

Who cannot join

Severe cognitive impairment or behavioral dysfunction such as not to understand or participate in the whole execution
Refusal or impossibility to provide informed consent
Impossibility to wear the robot:
for serious functional limitations in the coxo-femoral joints and knees;
marked hyper tone with sudden spasms in flexion;
Modified Ashworth Scale > 3;

Show all 10Show fewer

weight over 113 Kg;
height less than 155 cm or higher than 195 cm;
hip width greater than 46 cm.
Sever cardio-respiratory co-morbidities.

Trial locations and contacts

1 site in 1 country.

Italy1 site

IRCCS San Raffaele Pisana
Roma, Roma, 00163

Other trials in Italy

About this study

Official title: Longitudinal Pilot Study on the Feasibility of Integrating Gait Training Through a Novel Over-ground Wearable Robotic System to Traditional Rehabilitation in People With Pyramidal Hemisyndromes.

This interventional longitudinal pilot study is aimed to investigate the feasibility, clinical effects, and compliance (from the experienced therapists (Indego Specialists)' point of view) of using an over-ground wearable robotic system (Indego) for gait rehabilitation of people with PH in the clinical practice.

Two substudies will be conducted with the following aims: to explore changes in the gait pattern and muscle activity following Indego-assisted gait rehabilitation through the kinematic gait analysis (in subjects able to walk) associated with surface electromyography (sEMG) of 4 muscle groups of the lower limbs; to identify prognostic factors for walking recovery, investigating also the effect of the treatment on functional connectivity through the electroencephalographic (EEG) analysis.

In order to satisfy the study aims, 30 subjects with PH and walking impairment will be recruited and assessed both clinically and instrumentally (in case of substudies) at the beginning (T0) and the end (T1) of the treatment period.

Read the detailed description

The primary objective of this interventional longitudinal pilot study is to investigate the feasibility of using an over-ground wearable robotic system (Indego) for gait rehabilitation of people with PH associated with the traditional rehabilitation.

Secondary objectives of the study are:

To explore the clinical effects of the treatment;
To evaluate the feasibility of implementing this system in clinical practice from experienced therapists (Indego Specialists)' point of view.

Two Sub-Studies (SS) will be conducted with the following aims:

Kinematic gait analysis (in subjects able to walk) associated with surface electromyography (sEMG) of 4 muscle groups of the lower limbs in order to evaluate changes in the gait pattern and muscle activity following gait rehabilitation through an over-ground wearable exoskeleton system;
Electroencephalographic (EEG) analysis in order to: identify prognostic factors for walking recovery; investigate the effect of the treatment on functional connectivity.

30 subjects with PH and walking impairment who meet the research project inclusion and exclusion criteria will be recruited for this study. Patients will be evaluated at T0 and at T1. Demographic (gender, date of birth, height, weight, education, dominant side, work activity, presence of the social network, presence of architectural barriers at home) and clinical data (comorbidity, drug therapy, blood pressure, the cardiac frequency at rest, date of last acute event, number of previous neurological events, location of acute events) of all participants will be recorded at T0. In the case of Sub-Studies, 10 patients (able to walk fo 4 meters without aids but with supervision) for SS1 and 5 patients for SS2 following the first-ever monofocal cerebrovascular acute event will be recruited. These subjects will be assessed both clinically and instrumentally (SS1: through the gait analysis and sEMG; SS2: through the EEG) at T0 and T1.

Conditions: Stroke, Brain Injuries, Traumatic, Brain Tumor Benign
Being tested: Indego Therapy
Keywords: Gait rehabilitation, Robot-assisted rehabilitation, Walking recovery, Cerebro-vascular disease, Cereberal activity
Medical subject headings: Stroke, Brain Injuries, Traumatic, Brain Neoplasms

What participants receive

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

Indego TherapyDevice
Indego Therapy consists of 15 + 2 sessions of Indego - Therapy, each lasting 30 minutes for a maximum of 6 weeks. All the device parameters such as step height (knee and hip), step length, step cycle speed, single and bilateral assistance are customizable. The use of aids during Idego-Therapy is allowed if needed. The Indego specialist should initially be positioned behind the patient, checking the exoskeleton and patient's gait pattern. The supervision of an assistant placed on the patient's healthy side is recommended in the first sessions in order to ensure greater safety to the patient. Constant supervision should be provided by Indego specialist during the whole treatment.

Study groups in NCT04559724
Study group	Role	What they receive
Indego-Assisted Gait Rehabilitation	Experimental	Every session of Indego-assisted gait rehabilitation will last 30 minutes, excluding preparation times (dressing, measurements, and adaptation of the brace to the anthropological measures of the various patients). The Indego program will be set based on the patient's ambulatory abilities, assessed by the Functional Ambulation Classification (FAC): * subjects unable to walk or high-.assistance needed (FAC = 0-2): Motion + program; * Subjects able to walk with mid/mini assistance or with supervision only (FAC = 3-5): Therapy + program. * During the treatment, the program change from Motion + to Therapy + is allowed based on the experts' opinion. Receives: Device: Indego Therapy

What is being measured

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

Changes in 6 Minute Walk 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.
Measured: Session 1 (Baseline-day1, T1), and Session 15 (end of treatment-day 35, T2).

Secondary outcomes (8)

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 is 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-day1, T1), and Session 15 (end of treatment-day 35, T2).
Change in Timed Up And Go (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 leaned 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-day1, T1), and Session 15 (end of treatment-day 35, T2).
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 (treatment onset, T1), and Session 15+2 (end of treatment, 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.
Measured: Session 1 (treatment onset, T1), and Session 15+2 (end of treatment, T2).
Change in Functional Ambulation Classification (FAC)
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.
Measured: Session 1 (treatment onset, T1), and Session 15+2 (end of treatment, T2).
Change in Barthel Index (BI)
The BI is a measure of Activity of Daily Living (ADL), which shows the degree of independence of a patient from any assistance. Each performance item is rated on this scale with a given number of points assigned to each level or ranking. It uses ten variables describing ADL and mobility. A higher number is associated with a greater likelihood of being able to live at home with a degree of independence following discharge from hospital.
Measured: Session 1 (Baseline-day1, T1), and Session 15 (end of treatment-day 35, 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. The score ranges from 1 to 6, and do higher values represent a better outcome.
Measured: Session 1 (Baseline-day1, T1), and Session 15 (end of treatment-day 35, 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
Measured: Session 1 (Baseline-day1, T1), and Session 15 (end of treatment-day 35, T2).

Timeline

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

1 Sep 2020Dec 2026

First posted23 Sep 2020
Study start1 Sep 2020
Primary completionDec 2026 (estimated)
Study completionDec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (20)Papers the sponsor has linked to this study.
Other trials for 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04559724
Sponsor's protocol ID: RP 20/13
Acronym: GAITGO
Status last verified: Oct 2026
First submitted: 7 Sep 2020
Last updated: 19 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Lord SE, McPherson K, McNaughton HK, Rochester L, Weatherall M. Community ambulation after stroke: how important and obtainable is it and what measures appear predictive? Arch Phys Med Rehabil. 2004 Feb;85(2):234-9. doi: 10.1016/j.apmr.2003.05.002.
PubMed 14966707
Robinson CA, Shumway-Cook A, Ciol MA, Kartin D. Participation in community walking following stroke: subjective versus objective measures and the impact of personal factors. Phys Ther. 2011 Dec;91(12):1865-76. doi: 10.2522/ptj.20100216. Epub 2011 Oct 14.
PubMed 22003172
Perry J. Analisi del movimento. Elsevier Italia srl, Milano 2005.
Pearson KG. Common principles of motor control in vertebrates and invertebrates. Annu Rev Neurosci. 1993;16:265-97. doi: 10.1146/annurev.ne.16.030193.001405. No abstract available.
PubMed 8460894
Barbeau H, Rossignol S. Recovery of locomotion after chronic spinalization in the adult cat. Brain Res. 1987 May 26;412(1):84-95. doi: 10.1016/0006-8993(87)91442-9.
PubMed 3607464
Dietz V, Zijlstra W, Duysens J. Human neuronal interlimb coordination during split-belt locomotion. Exp Brain Res. 1994;101(3):513-20. doi: 10.1007/BF00227344.
PubMed 7851518
Edgerton VR, Tillakaratne NJ, Bigbee AJ, de Leon RD, Roy RR. Plasticity of the spinal neural circuitry after injury. Annu Rev Neurosci. 2004;27:145-67. doi: 10.1146/annurev.neuro.27.070203.144308.
PubMed 15217329
Richards CL, Malouin F, Bravo G, Dumas F, Wood-Dauphinee S. The role of technology in task-oriented training in persons with subacute stroke: a randomized controlled trial. Neurorehabil Neural Repair. 2004 Dec;18(4):199-211. doi: 10.1177/1545968304269397.
PubMed 15537991
Nichols-Larsen DS, Clark PC, Zeringue A, Greenspan A, Blanton S. Factors influencing stroke survivors' quality of life during subacute recovery. Stroke. 2005 Jul;36(7):1480-4. doi: 10.1161/01.STR.0000170706.13595.4f. Epub 2005 Jun 9.
PubMed 15947263
Franceschini M, Carda S, Agosti M, Antenucci R, Malgrati D, Cisari C; Gruppo Italiano Studio Allevio Carico Ictus. Walking after stroke: what does treadmill training with body weight support add to overground gait training in patients early after stroke?: a single-blind, randomized, controlled trial. Stroke. 2009 Sep;40(9):3079-85. doi: 10.1161/STROKEAHA.109.555540. Epub 2009 Jun 25.
PubMed 19556526
Duncan PW, Sullivan KJ, Behrman AL, Azen SP, Wu SS, Nadeau SE, Dobkin BH, Rose DK, Tilson JK, Cen S, Hayden SK; LEAPS Investigative Team. Body-weight-supported treadmill rehabilitation after stroke. N Engl J Med. 2011 May 26;364(21):2026-36. doi: 10.1056/NEJMoa1010790.
PubMed 21612471
Hidler JM, Wall AE. Alterations in muscle activation patterns during robotic-assisted walking. Clin Biomech (Bristol). 2005 Feb;20(2):184-93. doi: 10.1016/j.clinbiomech.2004.09.016.
PubMed 15621324
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
Sale P, Franceschini M, Waldner A, Hesse S. Use of the robot assisted gait therapy in rehabilitation of patients with stroke and spinal cord injury. Eur J Phys Rehabil Med. 2012 Mar;48(1):111-21.
PubMed 22543557
Esquenazi A, Talaty M, Jayaraman A. Powered Exoskeletons for Walking Assistance in Persons with Central Nervous System Injuries: A Narrative Review. PM R. 2017 Jan;9(1):46-62. doi: 10.1016/j.pmrj.2016.07.534. Epub 2016 Aug 24.
PubMed 27565639

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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Study at a glance

From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Longitudinal Pilot Study on the Feasibility of Integrating Gait Training Through a Novel Over-ground Wearable Robotic System to Traditional Rehabilitation in People With Pyramidal Hemisyndromes.
ClinicalTrials.gov ID: NCT04559724
Acronym / sponsor ID: GAITGO / RP 20/13
Conditions: Stroke, Brain Injuries, Traumatic, Brain Tumor Benign
Keywords: Gait rehabilitation, Robot-assisted rehabilitation, Walking recovery, Cerebro-vascular disease, Cereberal activity
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 30 participants (actual)
Lead sponsor: IRCCS San Raffaele RomaUniversity, hospital or other
Study start: 1 Sep 2020 (actual)
Primary completion: Dec 2026 (estimated)
Study completion: Dec 2026 (estimated)
First posted: 23 Sep 2020 (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

Secondary objectives of the study are:

To explore the clinical effects of the treatment;
To evaluate the feasibility of implementing this system in clinical practice from experienced therapists (Indego Specialists)' point of view.

Two Sub-Studies (SS) will be conducted with the following aims:

Kinematic gait analysis (in subjects able to walk) associated with surface electromyography (sEMG) of 4 muscle groups of the lower limbs in order to evaluate changes in the gait pattern and muscle activity following gait rehabilitation through an over-ground wearable exoskeleton system;
Electroencephalographic (EEG) analysis in order to: identify prognostic factors for walking recovery; investigate the effect of the treatment on functional connectivity.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Indego-Assisted Gait Rehabilitation	Experimental	Device: Indego TherapyEvery session of Indego-assisted gait rehabilitation will last 30 minutes, excluding preparation times (dressing, measurements, and adaptation of the brace to the anthropological measures of the various patients). The Indego program will be set based on the patient's ambulatory abilities, assessed by the Functional Ambulation Classification (FAC): * subjects unable to walk or high-.assistance needed (FAC = 0-2): Motion + program; * Subjects able to walk with mid/mini assistance or with supervision only (FAC = 3-5): Therapy + program. * During the treatment, the program change from Motion + to Therapy + is allowed based on the experts' opinion.

Who may qualify

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

Key inclusion criteria (10 listed)

Single or multiple unilateral Cerebral Stroke
Mild / moderate Traumatic Brain Injury
Brain Tumor Benign
Possibility to keep the upright position for at least 1 minute with good cardiovascular compensation and:

Key exclusion criteria (10 listed)

Severe cognitive impairment or behavioral dysfunction such as not to understand or participate in the whole execution
Refusal or impossibility to provide informed consent
Impossibility to wear the robot:
Sever cardio-respiratory co-morbidities.

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
Indego TherapyIndego Therapy consists of 15 + 2 sessions of Indego - Therapy, each lasting 30 minutes for a maximum of 6 weeks. All the device parameters such as step height (knee and hip), step length, step cycle speed, single and bilateral assistance are customizable. The use of aids during Idego-Therapy is allowed if needed. The Indego specialist should initially be positioned behind the patient, checking the exoskeleton and patient's gait pattern. The supervision of an assistant placed on the patient's healthy side is recommended in the first sessions in order to ensure greater safety to the patient. Constant supervision should be provided by Indego specialist during the whole treatment.	Device	Indego-Assisted Gait Rehabilitation

Primary outcome

Changes in 6 Minute Walk Test (6MWT)
Time frame: Session 1 (Baseline-day1, T1), and Session 15 (end of treatment-day 35, 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.

8 secondary outcomes

Change in 10 Meter Walk Test (10MWT)
Time frame: Session 1 (Baseline-day1, T1), and Session 15 (end of treatment-day 35, T2).
Change in Timed Up And Go (TUG)
Time frame: Session 1 (Baseline-day1, T1), and Session 15 (end of treatment-day 35, T2).
Change in Modified Ashworth Scale (MAS)
Time frame: Session 1 (treatment onset, T1), and Session 15+2 (end of treatment, T2).
Change in Trunk Control Test (TCT)
Time frame: Session 1 (treatment onset, T1), and Session 15+2 (end of treatment, T2).
Change in Functional Ambulation Classification (FAC)
Time frame: Session 1 (treatment onset, T1), and Session 15+2 (end of treatment, T2).
Change in Barthel Index (BI)
Time frame: Session 1 (Baseline-day1, T1), and Session 15 (end of treatment-day 35, T2).
Change in Walking Handicap Scale (WHS)
Time frame: Session 1 (Baseline-day1, T1), and Session 15 (end of treatment-day 35, T2).
Change in Motricity Index (MI)
Time frame: Session 1 (Baseline-day1, T1), and Session 15 (end of treatment-day 35, T2).

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
Background: PubMed 14966707Lord SE, McPherson K, McNaughton HK, Rochester L, Weatherall M. Community ambulation after stroke: how important and obtainable is it and what measures appear predictive? Arch Phys Med Rehabil. 2004 Feb;85(2):234-9. doi: 10.1016/j.apmr.2003.05.002.
Background: PubMed 22003172Robinson CA, Shumway-Cook A, Ciol MA, Kartin D. Participation in community walking following stroke: subjective versus objective measures and the impact of personal factors. Phys Ther. 2011 Dec;91(12):1865-76. doi: 10.2522/ptj.20100216. Epub 2011 Oct 14.
BackgroundPerry J. Analisi del movimento. Elsevier Italia srl, Milano 2005.
Background: PubMed 8460894Pearson KG. Common principles of motor control in vertebrates and invertebrates. Annu Rev Neurosci. 1993;16:265-97. doi: 10.1146/annurev.ne.16.030193.001405. No abstract available.
Background: PubMed 3607464Barbeau H, Rossignol S. Recovery of locomotion after chronic spinalization in the adult cat. Brain Res. 1987 May 26;412(1):84-95. doi: 10.1016/0006-8993(87)91442-9.
Background: PubMed 7851518Dietz V, Zijlstra W, Duysens J. Human neuronal interlimb coordination during split-belt locomotion. Exp Brain Res. 1994;101(3):513-20. doi: 10.1007/BF00227344.
Background: PubMed 15217329Edgerton VR, Tillakaratne NJ, Bigbee AJ, de Leon RD, Roy RR. Plasticity of the spinal neural circuitry after injury. Annu Rev Neurosci. 2004;27:145-67. doi: 10.1146/annurev.neuro.27.070203.144308.
Background: PubMed 15537991Richards CL, Malouin F, Bravo G, Dumas F, Wood-Dauphinee S. The role of technology in task-oriented training in persons with subacute stroke: a randomized controlled trial. Neurorehabil Neural Repair. 2004 Dec;18(4):199-211. doi: 10.1177/1545968304269397.
Background: PubMed 15947263Nichols-Larsen DS, Clark PC, Zeringue A, Greenspan A, Blanton S. Factors influencing stroke survivors' quality of life during subacute recovery. Stroke. 2005 Jul;36(7):1480-4. doi: 10.1161/01.STR.0000170706.13595.4f. Epub 2005 Jun 9.
Background: PubMed 19556526Franceschini M, Carda S, Agosti M, Antenucci R, Malgrati D, Cisari C; Gruppo Italiano Studio Allevio Carico Ictus. Walking after stroke: what does treadmill training with body weight support add to overground gait training in patients early after stroke?: a single-blind, randomized, controlled trial. Stroke. 2009 Sep;40(9):3079-85. doi: 10.1161/STROKEAHA.109.555540. Epub 2009 Jun 25.
Background: PubMed 21612471Duncan PW, Sullivan KJ, Behrman AL, Azen SP, Wu SS, Nadeau SE, Dobkin BH, Rose DK, Tilson JK, Cen S, Hayden SK; LEAPS Investigative Team. Body-weight-supported treadmill rehabilitation after stroke. N Engl J Med. 2011 May 26;364(21):2026-36. doi: 10.1056/NEJMoa1010790.
Background: PubMed 15621324Hidler JM, Wall AE. Alterations in muscle activation patterns during robotic-assisted walking. Clin Biomech (Bristol). 2005 Feb;20(2):184-93. doi: 10.1016/j.clinbiomech.2004.09.016.
Individual participant dataSharing planned: No

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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.

Sanaz Pournajaf, Dr. principal investigator

IRCCS San Raffaele Pisana

Marco Franceschini, Prof. study chair

IRCCS San Raffaele Pisana

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

Questions about this trial

What is this clinical trial studying?

A study testing Indego Therapy in people with Stroke and Brain Injuries, Traumatic, run by IRCCS San Raffaele Roma at 1 site 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 10 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

This study is still under way. Results are not available in the source record yet.

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?

Changes in 6 Minute Walk Test (6MWT) (time frame: Session 1 (Baseline-day1, T1), and Session 15 (end of treatment-day 35, 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 NCT04559724, which also lists 20 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 19 Oct 2026; AzTrials last refreshed its copy on 31 Oct 2026.