About this trial
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 criteria
Qualifiers
Diagnosis of stroke (ischemic or hemorrhagic) ≥ 3 months
Age ≥ 18a and ≤ 80a
6MWT ≤ 200m
Barthel Index ≤ 95
Disqualifiers
The presence of any comorbidity or disability other than stroke that would preclude gait training
Any uncontrolled health condition for which exercise is contraindicated
Trial design
Treatments tested in this trial
- Lokomat + Vibramoov
- Lokomat
Treatment groups
Sponsors and collaborators
Ludwig Boltzmann Institute for Arthritis and Rehabilitation
Lead sponsor
Reha-Zentrum Gröbming
Collaborator