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RECRUITING
NCT07350798
NA

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

Sponsor: Somogy Megyei Kaposi Mór Teaching Hospital

View on ClinicalTrials.gov

Summary

* 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.

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-02-01

Completion Date

2028-08-01

Last Updated

2026-07-29

Healthy Volunteers

No

Conditions

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 improving performance of the participants. The movements used here require a high level of attention and executive functions, as well as rapid cognitive processing speed to visual and auditory signals. The training provides strong neuromuscular stimulation due to the constantly changing sensory environment, such as soft/hard surface tasks, heavy/light tools, slow/fast movement execution, and reflexive/conscious reactions to external stimuli during the task. 5 times/week for 3 weeks, 45 minutes each.

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 continuously adjusted to the patient's needs from an external controller, so that therapy can be performed in a specialized manner for the individual. 5 times/week for 3 weeks, 45 minutes each.

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 various tasks to be projected onto the treadmill belt, providing immediate real-time feedback to the patient and therapist via the force platform. 5 times/week for 3 weeks, 45 minutes each.

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.

Locations (1)

Somogy County Kaposi Mór Teaching Hospital

Kaposvár, Somogy County, Hungary