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

NCT07529054 | Recruiting

• 1 other identifier: LudwigBoltzmannAR
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Robotic Assisted Gait Training; Vibration Therapy; Gait Biomechanics

Keywords

Robotic Assisted Gait Training; Functional Proprioceptive Stimulation; Gait Parameter

Outcome Measures

Primary Outcomes (2)

• Spatio Temporal Gait Parameter (STGP)

  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)

  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 Outcomes (6)

• Brain Derived Neurotrophic Factor (BDNF)

  At baseline and 4 weeks later after intervention

• Routine Laboratory Parameter

  At baseline and 4 weeks later after intervention

• Berg Balance Scale

  At baseline and 4 weeks later after intervention

• Functional Ambulation Category (FAC)

  At baseline and 4 weeks later after intervention

• Patient Health Questionnaire-4 (PHQ-4)

  At baseline and 4 weeks later after intervention

Study Arms (2)

Lokomat + Vibramoov

EXPERIMENTAL

Patients in the interventional group receive RAGT (Lokomat) combined with vibrational stimuli (Vibramoov). Additionally they receive the standard rehabiliation procedure.

Device: Lokomat + Vibramoov

Lokomat

ACTIVE COMPARATOR

Patients in the interventional group receive the conventional RAGT (Lokomat) without vibrational stimuli (Vibramoov). Additionally they receive the standard rehabiliation procedure.

Device: Lokomat

Interventions

Lokomat + Vibramoov DEVICE

The conventional Robotic Assisted Gait Training is combined with vibrational stimuli which is a novel approach.

Lokomat + Vibramoov

Lokomat DEVICE

Conventional Robotic Assisted Gait Training with the Lokomat

Lokomat

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ludwig Boltzmann Institute for Arthritis and Rehabilitation: lead
• Reha-Zentrum Gröbming: collaborator

Study Sites (1)

Reha-Zentrum Gröbming

Gröbming, Styria, 8962, Austria

RECRUITING

Related Publications (1)

• [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.

  BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Bibiane Steinecker-Frohnwieser, Priv. Doz. Mag. Dr.

  Ludwig Boltzmann Institut Arthritis und Rehabilitation

  STUDY DIRECTOR

Central Study Contacts

Maximilian Kondler, BSc, MMSc

CONTACT

+43(0)3685-22323; maximilian.kondler@pv.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Participants are randomized to either the control group or the intervention group. To ensure a balanced distribution between groups, a minimization approach considering four stratification factors-age, sex, spasticity, and stroke phase-is used.

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 14, 2026
• Study Start: January 5, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)