RecruitingNot ApplicableNCT07529054

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

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


Sponsor

Ludwig Boltzmann Institute for Arthritis and Rehabilitation

Enrollment

40 participants

Start Date

Jan 5, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria8

  • 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

Exclusion Criteria2

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

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Interventions

DEVICELokomat + Vibramoov

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

DEVICELokomat

Conventional Robotic Assisted Gait Training with the Lokomat


Locations(1)

Reha-Zentrum Gröbming

Gröbming, Styria, Austria

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NCT07529054


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