Applicability of Robotic Devices, Virtual and Augmented Reality in the Rehabilitation of People With Stroke During Treadmill Training
1 other identifier
interventional
80
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Aug 2025
Typical duration for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2025
CompletedFirst Submitted
Initial submission to the registry
December 15, 2025
CompletedFirst Posted
Study publicly available on registry
January 20, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2028
January 20, 2026
January 1, 2026
1.4 years
December 15, 2025
January 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Modified Rankin Scale (mRS)
The modified Rankin Scale (mRS) indicates the degree of independence in daily activities and the severity of disability. The method for assessing mRs is a guided interview. . The scoring is divided as follows: 0-No symptoms; 1-No significant disability. Able to carry out activities of daily living despite some symptoms; 2-Mild disability. Able to look after himself without assistance but not able to carry out all previous activities; 3-Moderate disability. Needs some assistance with activities of daily living but can walk without assistance; 4-Moderately severe disability. Unassisted, unable to meet his/her own physical needs, unable to walk without assistance; 5-Severe disability. Bedridden, incontinent, requires constant nursing care; 6-Dead
3 weeks
Secondary Outcomes (10)
36-Item Short Form Survey (SF-36)
3 weeks
Stroke Impact Scale-16 (SIS-16)
3 weeks
Berg Balance Scale (BBS)
3 weeks
Tinetti test
3 weeks
6 minute walking test (6MWT)
3 weeks
- +5 more secondary outcomes
Study Arms (4)
TT
EXPERIMENTALReceiving high intensity treadmill training
R-TT
EXPERIMENTALReceiving high intensity treadmill training with ReStore robotic device.
VR&AR-TT
EXPERIMENTALReceiving treadmill training with C-Mill, a special treadmill that provides virtual and augmented reality.
C-TT
EXPERIMENTALReceiving treadmill training with the combination of the ReStore and C-Mill system.
Interventions
The TT group performs high-intensity treadmill training on a conventional treadmill. 5 times/week for 3 weeks, 30 minutes each.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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;
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Somogy County Kaposi Mór Teaching Hospital
Kaposvár, Somogy County, 7400, Hungary
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
József Dr. habil. Tollár
Somogy County Kaposi Mór Teaching Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Department
Study Record Dates
First Submitted
December 15, 2025
First Posted
January 20, 2026
Study Start
August 1, 2025
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
August 1, 2028
Last Updated
January 20, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share