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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Austria
Reha-Zentrum Gröbming
RECRUITING
Gröbming
Contact Information
Primary
Maximilian Kondler, BSc, MMSc
maximilian.kondler@pv.at
+43(0)3685-22323
Time Frame
Start Date: 2026-01-05
Estimated Completion Date: 2027-12
Participants
Target number of participants: 40
Treatments
Experimental: Lokomat + Vibramoov
Patients in the interventional group receive RAGT (Lokomat) combined with vibrational stimuli (Vibramoov). Additionally they receive the standard rehabiliation procedure.
Active_comparator: Lokomat
Patients in the interventional group receive the conventional RAGT (Lokomat) without vibrational stimuli (Vibramoov). Additionally they receive the standard rehabiliation procedure.
Related Therapeutic Areas
Sponsors
Leads: Ludwig Boltzmann Institute for Arthritis and Rehabilitation
Collaborators: Reha-Zentrum Gröbming

This content was sourced from clinicaltrials.gov