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

Somogy Megyei Kaposi Mór Teaching Hospital

Status: Enrolling

Conditions: Stroke

Treatments: Other: Treadmill Training; Other: Combined Treadmill Training; Other: Treadmill Training with Virtual and Augmented Reality; Other: Robot Assisted Treadmill Training

Study type: Interventional

Funder types: Other

Identifiers

NCT07350798

IG/1357-0/2025

Details and patient eligibility

About

• 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 4 patient groups

TT

Experimental group

Description:

Receiving high intensity treadmill training

Treatment:

Other: Treadmill Training

R-TT

Experimental group

Description:

Receiving high intensity treadmill training with ReStore robotic device.

Treatment:

Other: Robot Assisted Treadmill Training

VR&AR-TT

Experimental group

Description:

Receiving treadmill training with C-Mill, a special treadmill that provides virtual and augmented reality.

Treatment:

Other: Treadmill Training with Virtual and Augmented Reality

C-TT

Experimental group

Description:

Receiving treadmill training with the combination of the ReStore and C-Mill system.

Treatment:

Other: Combined Treadmill Training