Applicability of Robotic Devices, Virtual and Augmented Reality in the Rehabilitation of People With Stroke During Treadmill Training

Overview

* Objective assessment of clinical symptoms, mobility and quality of life changes resulting from stroke and determination of changes resulting from therapies. * Assessment of the rehabilitation effectiveness of traditional high intensity training. * Assessment of the rehabilitation effectiveness of gait training performed on a treadmill with a robot-assisted soft-exoskeleton. * Assessment of the rehabilitation effectiveness of treadmill training supplemented with virtual and augmented reality. * Determination of the joint application possibilities of robot-assisted and virtual and augmented reality treadmill training in order to further increase the effectiveness. * Comparison of the effectiveness of different trainings. * Mapping of changes in gait patterns due to therapies using 3D motion analysis. * Mapping of changes in postural stability due to therapies using posturography.

Interventions

• Other High Intensity Training
  During HIT participants perform gait exercises, coordination tasks, balance exercises, posture improvement exercises and muscle strengthening with and without the use of various devices (Dynair cushion, Bosu, Pilates ball, weight ball, dead weight stick, TRX, coordination ladder and obstacles). This includes surface changes and changes of direction during the tasks, manipulation of the speed of the tasks and the use of height stimuli. The difficulty of the tasks is adjusted each time to the impr
• Other Robot Assisted Treadmill Training
  The R-TT group performs high-intensity treadmill training on a conventional treadmill. Before the training begins, the ReStore Soft exoskeleton, which is a special gait assist device, is fitted. The device uses motion sensors to process the movements of the lower limb on the healthy side and uses a motor attached to the waist to map them using bowden cables while walking on the affected paretic side in real time. During therapy, the amount of assistance provided by the exoskeleton can be continu
• Other Treadmill Training with Virtual and Augmented Reality
  The VR\&AR-TT group performs treadmill training on a special treadmill, the C-Mill VR+ device, for which the virtual and augmented reality movement programs are provided by the CueFors 2.5 software, which is the original control software for the C-Mill. The C-Mill VR+ system is a 3 m long and 1 m wide treadmill with a force platform underneath. A 65" fixed-position monitor in front of the treadmill provides the virtual reality environment, and a projector placed next to the treadmill allows vari
• Other Combined Treadmill Training
  Patients in the C-TT group use the ReStore Soft exoskeleton and the C-Mill VR+ system together. 5 times/week for 3 weeks, 45 minutes each.

Primary outcome measures

• Modified Rankin Scale (mRS) [Time frame: 3 weeks]

Secondary outcome measures (10)

• Barthel Index (BI) [Time frame: 3 weeks]
• Functional Independence Measure scale (FIM) [Time frame: 3 weeks]
• Berg Balance Scale (BBS) [Time frame: 3 weeks]
• Tinetti test [Time frame: 3 weeks]
• 6 minute walking test (6MWT) [Time frame: 3 weeks]
• 10 meter walking test [Time frame: 3 weeks]
• Posturographic examination [Time frame: 3 weeks]
• 3D gait analysis - Spatiotemporal parameters [Time frame: 3 weeks]
• 3D gait analysis - Spatial parameters [Time frame: 3 weeks]
• 10. 3D gait analysis - Temporal parameters [Time frame: 3 weeks]

Eligibility criteria

Inclusion criteria

• has had a first ischemic stroke diagnosed by a neurologist based on CT or MRI;
• neurological examination shows mobility and postural limitations;
• mRS score of 2 or higher;

Exclusion criteria

• multiple strokes in the medical history;
• systolic blood pressure less than 120 or greater than 160 mmHg;
• orthostatic hypotension;
• carotid artery stenosis;
• severe heart disease;
• hemophilia;
• traumatic brain injury;
• seizure disorder; untreated diabetes;
• abnormal electroencephalography;
• Mini Mental Test score < 22;
• abnormal blood panel;
• use of sedatives; irregular medication;
• severe aphasia (Western Aphasia Battery ≤ 25);
• severe vision or hearing impairment;
• severe sensory dysfunction;
• severe orthopedic problem;
• other neurological condition affecting motor function;
• alcoholism;
• drug use;
• smoking after stroke diagnosis;
• inability to walk at least 100 m with or without assistive devices in 6 minutes;
• BBS score ≤ 32;
• BI score ≤ 70;
• inability to understand verbal instructions or signals on a television screen;
• current participation in an individual or group exercise program outside of standard physiotherapy;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Hungary · 1 center

• Somogy County Kaposi Mór Teaching Hospital — Kaposvár

Identifiers

NCT: NCT07350798 · IG/1357-0/2025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗