The Potential of Robotic-Assisted Gait Training in a Rehabilitation Setting (RAGT_RGB)

April 7, 2026 updated by: Ludwig Boltzmann Institute for Arthritis and Rehabilitation

The Potential of Robotic-Assisted Gait Training in a Rehabilitation Settin

Robotic-assisted gait training (RAGT) devices, such as the Lokomat®, are commonly used to support gait rehabilitation by enabling repetitive, task-specific walking movements. The functional proprioceptive stimulation (FPS) device Vibramoov® represents a novel technology designed to stimulate proprioceptors at the muscle-tendon junction through targeted vibratory stimuli, thereby activating sensorimotor centers in the brain and potentially facilitating movement execution.

The aim of this randomized controlled trial is to investigate whether Lokomat® training combined with Vibramoov® leads to greater improvements in qualitative and quantitative gait parameters in stroke patients compared with Lokomat® training alone. The study will be conducted at the Gröbming Rehabilitation Center and will include patients undergoing a four-week neurological inpatient rehabilitation program. Participants will be randomly assigned to an intervention group (Lokomat® + Vibramoov®) or a control group (Lokomat® only), with 20 patients per group.

Primary outcomes include the 6-Minute Walk Test (6MWT) and spatiotemporal gait parameters. Additional assessments include functional scores, patient-reported outcome measures, and blood biomarkers. Statistical analyses will be performed depending on data distribution. A follow-up assessment evaluating EQ-5D and PHQ-4 will be conducted six months after completion of the rehabilitation program.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Stroke is the most common cause of physical disability in Western industrialized countries, with approximately 70% of patients experiencing moderate to severe physical impairments [1]. In addition to the negative impact on mobility and balance, activities of daily living are often affected [2]. In particular, gait impairments-manifested, for example, by reduced walking speed or shortened step length-can significantly reduce the quality of life of patients after stroke [2,3]. Therefore, the restoration of a physiological gait pattern in terms of both qualitative and quantitative parameters represents a key objective of post-stroke rehabilitation.

In addition to conventional therapeutic approaches, robotic-assisted gait training (RAGT) devices such as the Lokomat® are frequently used [4]. With this device, patients are able to walk actively on a treadmill while being supported by an exoskeleton that simulates a symmetrical, bilateral gait pattern [3]. RAGT devices aim to improve walking by enabling a high number of repetitions of task-oriented movements, thereby facilitating the relearning of movement patterns [5].

Novel technologies such as the functional proprioceptive stimulation (FPS) device Vibramoov® may have the potential to enhance the effectiveness of RAGT. This therapeutic device aims to stimulate proprioceptors located at the muscle-tendon junction through targeted vibratory stimuli, thereby activating sensorimotor centers in the brain via afferent Ia fibers [6]. As a result, the execution of movements-for example during walking-may be facilitated. According to the manufacturer, Vibramoov® can be used during walking on level ground, during treadmill walking, or in combination with the Lokomat®. However, to date there is no research investigating the effects of Vibramoov® on gait parameters in stroke patients undergoing inpatient rehabilitation.

The aim of the present study is therefore to contribute to the investigation of FPS as a potential approach to maximize the effectiveness of RAGT. The primary research question is: Does Lokomat® training combined with the Vibramoov® device have a greater effect on qualitative and quantitative gait parameters in patients after stroke compared with Lokomat® training alone? To address this research question, a randomized controlled trial will be conducted at the Gröbming Rehabilitation Center. Patients after stroke who are undergoing a four-week neurological inpatient rehabilitation program will be randomly assigned to either an intervention group or a control group. Based on data regarding the effect of RAGT on the 6-Minute Walk Test (6MWT), and accounting for potential dropouts, a sample size of 20 patients per group was calculated [4].

Patients in both groups will receive the conventional rehabilitation program according to the medical service profile, in which RAGT represents part of the standard treatment for stroke patients with gait impairments. Patients in the control group will perform RAGT using the Lokomat®, while patients in the intervention group will perform RAGT using the Lokomat® in combination with Vibramoov®. The extent of RAGT will be identical in both groups.

The effects of the intervention will be quantified using several outcome parameters, including the 6-Minute Walk Test (6MWT) and spatiotemporal gait parameters. In addition, various functional scores and patient-reported outcome measures will be collected, and laboratory parameters and blood biomarkers will be analyzed. Depending on the distribution of the data, standard statistical methods such as the independent t-test or the Mann-Whitney U test will be applied to address the research question. A follow-up assessment six months after completion of the study (telephone interview) evaluating EQ-5D and PHQ-4 is planned.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
    • Styria
      • Gröbming, Styria, Austria, 8962
        • Recruiting
        • Reha-Zentrum Gröbming

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of stroke (ischemic or hemorrhagic) ≥ 3 months
  • Age ≥ 18a and ≤ 80a
  • 6MWT ≤ 200m
  • Barthel Index ≤ 95
  • Mini Mental State Exam (MMSE) ≥ 24
  • FAC: ≤ 4
  • BBS): ≤49
  • Modified Ashworth Scale (MAS): 0-3 for the lower extremity

Exclusion Criteria:

  • The presence of any comorbidity or disability other than stroke that would preclude gait training
  • Any uncontrolled health condition for which exercise is contraindicated

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lokomat + Vibramoov
Patients in the interventional group receive RAGT (Lokomat) combined with vibrational stimuli (Vibramoov). Additionally they receive the standard rehabiliation procedure.
Device: Lokomat + Vibramoov
The conventional Robotic Assisted Gait Training is combined with vibrational stimuli which is a novel approach.
Active Comparator: Lokomat
Patients in the interventional group receive the conventional RAGT (Lokomat) without vibrational stimuli (Vibramoov). Additionally they receive the standard rehabiliation procedure.
Device: Lokomat
Conventional Robotic Assisted Gait Training with the Lokomat

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spatio Temporal Gait Parameter (STGP)
Time Frame: At baseline and 4 weeks later after intervention
STGP, such as cadence or step lenght measured in a clinical gait analysis by a pressure measuring plate.
At baseline and 4 weeks later after intervention
6 Minute Walk Test (6MWT)
Time Frame: At baseline and 4 weeks later after intervention
The 6MWT is a simple functional exercise test used to assess a person's walking capacity and endurance. It measures the distance a patient can walk in six minutes on a flat surface and reflects their submaximal level of functional capacity.
At baseline and 4 weeks later after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain Derived Neurotrophic Factor (BDNF)
Time Frame: At baseline and 4 weeks later after intervention
Biomarker measured in the serum, which is an indicator of the amount of neuroplasticity in the central nervous system.
At baseline and 4 weeks later after intervention
Routine Laboratory Parameter
Time Frame: At baseline and 4 weeks later after intervention
Routine laboratory parameter, such as inflammatory markers measured in the serum.
At baseline and 4 weeks later after intervention
Berg Balance Scale
Time Frame: At baseline and 4 weeks later after intervention
Assessment for evaluation of balance and risk of falls.
At baseline and 4 weeks later after intervention
Functional Ambulation Category (FAC)
Time Frame: At baseline and 4 weeks later after intervention
FAC is a clinical scale used to assess a patient's walking ability and level of assistance required for ambulation.
At baseline and 4 weeks later after intervention
Patient Health Questionnaire-4 (PHQ-4)
Time Frame: At baseline and 4 weeks later after intervention
The PHQ-4 is a brief screening questionnaire for anxiety and depression.
At baseline and 4 weeks later after intervention
European Quality of Life 5 Dimensions (EQ-5D)
Time Frame: At baseline and 4 weeks later after intervention
The EQ-5D is a standardized questionnaire used to measure health-related quality of life.
At baseline and 4 weeks later after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ludwig Boltzmann Institute for Arthritis and Rehabilitation

Collaborators

Reha-Zentrum Gröbming

Investigators

  • Study Director: Bibiane Steinecker-Frohnwieser, Priv. Doz. Mag. Dr., Ludwig Boltzmann Institut Arthritis und Rehabilitation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • [1] D. Calafiore, F. Negrini, N. Tottoli, F. Ferraro, O. Ozyemisci-Taskiran, und A. de Sire, "Efficacy of robotic exoskeleton for gait rehabilitation in patients with subacute stroke : a sys-tematic review", Eur J Phys Rehabil Med, Bd. 58, Nr. 1, S. 1-8, Feb. 2022, doi: 10.23736/S1973-9087.21.06846-5. [2] L. Wu, G. Xu, und Q. Wu, "The effect of the Lokomat® robotic-orthosis system on lower extremity rehabilitation in patients with stroke: a systematic review and meta-analysis", Front Neurol, Bd. 14, S. 1260652, 2023, doi: 10.3389/fneur.2023.1260652. [3] F. Baronchelli, C. Zucchella, M. Serrao, D. Intiso, und M. Bartolo, "The Effect of Robot-ic Assisted Gait Training With Lokomat® on Balance Control After Stroke: Systematic Review and Meta-Analysis", Front. Neurol., Bd. 12, Juli 2021, doi: 10.3389/fneur.2021.661815. [4] R. Mustafaoglu, B. Erhan, I. Yeldan, B. Gunduz, und E. Tarakci, "Does robot-assisted gait training improve mobility, activities of daily living and quality of life in stroke? A single-blinded, randomized controlled trial", Acta Neurol Belg, Bd. 120, Nr. 2, S. 335-344, Apr. 2020, doi: 10.1007/s13760-020-01276-8. [5] C. Schneider u. a., "Disentangling the percepts of illusory movement and sensory stimulation during tendon vibration in the EEG", NeuroImage, Bd. 241, S. 118431, Nov. 2021, doi: 10.1016/j.neuroimage.2021.118431. [6] R. S. Calabrò u. a., "Shaping neuroplasticity by using powered exoskeletons in pa-tients with stroke: a randomized clinical trial", J NeuroEngineering Rehabil, Bd. 15, Nr. 1, S. 35, Dez. 2018, doi: 10.1186/s12984-018-0377-8.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

April 7, 2026

First Submitted That Met QC Criteria

April 7, 2026

First Posted (Actual)

April 14, 2026

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LudwigBoltzmannAR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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