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NCT07350798
Applicability of Robotic Devices, Virtual and Augmented Reality in the Rehabilitation of People With Stroke During Treadmill Training
Conditions: Stroke
Sex: All
Ages: 18 Years – 99 Years
Healthy volunteers: No
Phase: NA
Enrollment: 80
Sponsor: Somogy Megyei Kaposi Mór Teaching Hospital
Location: Somogy County Kaposi Mór Teaching Hospital Kaposvár Somogy County
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.
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;
Source: ClinicalTrials.gov (NCT07350798). StuddyBuddy aggregates publicly available trial information.