NCT07350798

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Somogy Megyei Kaposi Mór Teaching Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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 treadmill 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 treadmill 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.

Conditions

• Stroke

Interventions

Type	Name	Description
OTHER	Treadmill Training	The TT group performs high-intensity treadmill training on a conventional treadmill. 5 times/week for 3 weeks, 30 minutes each.
OTHER	Robot Assisted Treadmill Training	The 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, 30 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, 30 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, 30 minutes each.

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-12-31
• Completion: 2028-08-01
• First posted: 2026-01-20
• Last updated: 2026-01-20

Locations

1 site across 1 country: Hungary