---
title: The Effects of Gait Rehabilitation After Stroke by Treadmill-based Robotics Versus Traditional Gait Training
nct_id: NCT03688165
overall_status: COMPLETED
sponsor: IRCCS San Raffaele Roma
study_type: OBSERVATIONAL
primary_condition: Stroke
countries: Italy
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03688165.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03688165"
ct_last_update_post_date: 2025-04-02
last_seen_at: "2026-05-12T06:31:49.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# The Effects of Gait Rehabilitation After Stroke by Treadmill-based Robotics Versus Traditional Gait Training

**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

**NCT ID:** [NCT03688165](https://clinicaltrials.gov/study/NCT03688165)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 87
- **Lead Sponsor:** IRCCS San Raffaele Roma
- **Collaborators:** Ospedale Santo Stefano, APSS Trento, Azienda Sanitaria n. 4 Chiavarese, Fondazione Don Carlo Gnocchi Onlus, Azienda Ospedaliera San Gerardo di Monza, University Hospital of Ferrara, Privatklinik Villa Melitta, Centro Ricerche Cliniche di Verona, Unità di Neuroriabilitazione, HABILITA, Istituto Piero Redaelli, Milano, S. Anna Hospital, Azienda Sanitaria Locale n.2 Savonese, Fondazione Centri di Riabilitazione Padre Pio Onlus, Habilita, Ospedale di Sarnico, I.R.C.C.S. Fondazione Santa Lucia, Azienda Ospedaliero, Universitaria Pisana, Azienda Socio Sanitaria Territoriale di Mantova
- **Conditions:** Stroke, Acute Stroke, Chronic Stroke
- **Start Date:** 2018-06-20
- **Completion Date:** 2022-07-30
- **CT.gov Last Update:** 2025-04-02

## Brief 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 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

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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 85 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
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
```

## Arms

- **Treadmill-based Robotic Gait Training** — The Treadmill-based Robotic Gait Training (TRGT) period will last 20 sessions, 3-5 days/week for at least 400' of exercise totally. The parameters to be respected for the robotic training will be the following for all patients: 0.9 km / h starting speed up to a maximum of 2.5 km / h; weight support not exceeding 40-45% of the body weight at the beginning and gradual progressive reduction depending on the case; for Lokomat: maximum assistance required at the start of treatment and gradual decrease during the treatment. The TRGT will always be associated with the traditional gait rehabilitation, and will be part of the Individual Rehabilitation Project which normally includes 3 hours of rehabilitation treatments for patients in the subacute phase, 60' of treatment for those in chronic phase.
- **Traditional Over-ground Gait Training** — The Traditional Over-ground Gait Training (TOGT) period will last 20 sessions, 3-5 days / week for a total time that corresponds to the same total time of traditional overground gait training, or at least 400' totally at the end of the period.

By Traditional Therapy we mean any technical approach aimed at achieving control of the postural passages from sitting upright, of load transfer in laterality and antero-posterior in orthostatism and reorganization of the step up to the assisted path to the parallels and then with various aids.

## Interventions

- **Treadmill-based Robotic Gait Training** (DEVICE) — 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 Training** (OTHER) — 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.

## Primary Outcomes

- **Change in 10 Meter Walk Test (10MWT)** _(time frame: at baseline (T0), at 2 months-the end of treatment (T1) and at 3 months after the end of rehabilitation-follow up (T2))_ — This test will assess the patient's speed during gait. Patients will be asked to walk at their preferred maximum and safe speed. Patients will be positioned 1 meter before the start line and instructed to walk 10 meters, and pass the end line approximately 1 meter after. The distance before and after the course are meant to minimize the effect of acceleration and deceleration. Time will be measured using a stopwatch and recorded to the one hundredth of a second (ex: 2.15 s). The test will be recorded 3 times, with adequate rests between them. The average of the 3 times should be recorded.

## Secondary Outcomes

- **Change in Timed Up and Go test (TUG)** _(time frame: at baseline (T0), at 2 months-the end of treatment (T1) and at 3 months after the end of rehabilitation-follow up (T2))_
- **Change in 6 Minute Walking Test (6MWT)** _(time frame: at baseline (T0), at 2 months-the end of treatment (T1) and at 3 months after the end of rehabilitation-follow up (T2))_
- **Change in Trunk Control Test (TCT)** _(time frame: at baseline (T0), at 2 months-the end of treatment (T1) and at 3 months after the end of rehabilitation-follow up (T2))_
- **Change in Motricity Index (MI)** _(time frame: at baseline (T0), at 2 months-the end of treatment (T1) and at 3 months after the end of rehabilitation-follow up (T2))_
- **Change in ModifiedAshworth Scale (MAS)** _(time frame: at baseline (T0), at 2 months-the end of treatment (T1) and at 3 months after the end of rehabilitation-follow up (T2))_
- **Change in Modified Barthel Index (mBI)** _(time frame: at baseline (T0), at 2 months-the end of treatment (T1) and at 3 months after the end of rehabilitation-follow up (T2))_
- **Change in Walking Handicap Scale (WHS)** _(time frame: at baseline (T0), at 2 months-the end of treatment (T1) and at 3 months after the end of rehabilitation-follow up (T2))_

## Locations (4)

- IRCCS San Raffaele Pisana, Roma, Italy, Italy
- U.O.C. Medicina Fisica e Riabilitazione, osp.S.Gerardo, Monza, Lombardy, Italy
- Irccs Centro Neurolesi Bonino Pulejo, Messina, Italy
- Irccs Fondazione Santa Lucia, Roma, Italy

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.irccs san raffaele pisana|roma|italy|italy` — added _(2026-05-12)_
- `locations.u.o.c. medicina fisica e riabilitazione, osp.s.gerardo|monza|lombardy|italy` — added _(2026-05-12)_
- `locations.irccs centro neurolesi bonino pulejo|messina||italy` — added _(2026-05-12)_
- `locations.irccs fondazione santa lucia|roma||italy` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03688165.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03688165*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*