Robotic and virtual/augmented reality treadmill training to improve walking after stroke

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

This trial will try different treadmill trainings—including regular walking, robot-assisted exoskeleton support, virtual and augmented reality, and combined approaches—to help people after a first ischemic stroke walk and balance better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Somogy Megyei Kaposi Mór Teaching Hospital (Academic / other)
• Locations: 1 site (Kaposvár, Somogy County)
• Trial ID: NCT07350798 on ClinicalTrials.gov

What this trial studies

Adults who had a first ischemic stroke and meet mobility and cognitive criteria are assigned to one of four treadmill-based rehabilitation programs: traditional treadmill training, robot-assisted soft-exoskeleton treadmill training, treadmill training with virtual and augmented reality, or a combined robot plus virtual/augmented reality program. Participants undergo pre- and post-intervention testing using clinical scales for mobility and function, 3D motion capture to map gait changes, and posturography to quantify balance. Therapists deliver supervised gait sessions on-site at the Kaposi Mór Teaching Hospital, and outcomes are compared across the different training modalities to determine which approach produces greater improvements. The study also examines safety and feasibility of combining robotic assistance with virtual and augmented reality during treadmill rehabilitation.

Who should consider this trial

Good fit: Ideal candidates are adults after a first ischemic stroke with measurable mobility and postural deficits (mRS ≥ 2) who can walk at least 100 m in six minutes and have sufficient cognition (Mini Mental Test ≥ 22) and sensory function to participate.

Not a fit: Patients with multiple strokes, severe cardiovascular or neurological comorbidities, uncontrolled blood pressure, severe cognitive or language impairment, inability to walk 100 m, or very low balance or functional scores are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the approaches could speed recovery of walking ability and balance after stroke and offer more effective, engaging rehabilitation options.

How similar studies have performed: Previous studies of robot-assisted gait training and VR-enhanced rehabilitation after stroke have shown promising but mixed improvements in walking and balance, so combining these approaches builds on partially validated methods.

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;

Where this trial is running

Kaposvár, Somogy County

• Somogy County Kaposi Mór Teaching Hospital — Kaposvár, Somogy County, Hungary (Recruiting)

Study contacts

• Principal investigator: József Dr. habil. Tollár — Somogy County Kaposi Mór Teaching Hospital
• Study coordinator: Nándor Prontvai

Conditions Stroke; stroke; robotic; virtual reality; augmented reality; rehabilitation; treadmill training