The Potential of Robotic-Assisted Gait Training in a Rehabilitation Setting
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorLudwig Boltzmann Institute for Arthritis and Rehabilitation
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Lokomat + Vibramoov
DeviceThe conventional Robotic Assisted Gait Training is combined with vibrational stimuli which is a novel approach.
Lokomat
DeviceConventional Robotic Assisted Gait Training with the Lokomat
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Lokomat + VibramoovExperimental treatment 1 intervention
Group B: LokomatActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Spatio Temporal Gait Parameter (STGP)
STGP, such as cadence or step lenght measured in a clinical gait analysis by a pressure measuring plate.
Time frame
At baseline and 4 weeks later after intervention2
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.
Time frame
At baseline and 4 weeks later after interventionSecondary outcomes
1
Brain Derived Neurotrophic Factor (BDNF)
Biomarker measured in the serum, which is an indicator of the amount of neuroplasticity in the central nervous system.
Time frame
At baseline and 4 weeks later after intervention2
Routine Laboratory Parameter
Routine laboratory parameter, such as inflammatory markers measured in the serum.
Time frame
At baseline and 4 weeks later after intervention3
Berg Balance Scale
Assessment for evaluation of balance and risk of falls.
Time frame
At baseline and 4 weeks later after intervention4
Functional Ambulation Category (FAC)
FAC is a clinical scale used to assess a patient's walking ability and level of assistance required for ambulation.
Time frame
At baseline and 4 weeks later after interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ludwig Boltzmann Institute for Arthritis and Rehabilitation
Lead sponsor
Reha-Zentrum Gröbming
Collaborator
Source ClinicalTrials.gov