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Effect of Transcutaneous Auricular Vagus Nerve Stimulation Combined With Upper Extremity Robot-Assisted Training on Upper Extremity Motor Functions in Stroke Patients

RecruitingNAAges 18 Years - 70 YearsAllIstanbul University - Cerrahpasa
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In plain words

What the trial is, and whether it could suit you

The effects of stroke on the upper extremity are a common and significant cause of long-term disability, with 65% of patients reporting an inability to participate in daily activities with the affected upper extremity after 6 months. Robotic-assisted training (RAT) has been widely used in recent years to improve upper extremity function. RAT positively impacts upper extremity function and activities of daily living by inducing motor learning from intense, highly repetitive, and task-focused movements of the upper extremity. However, current, limited clinical solutions, including minimally invasive transcutaneous auricular vagus nerve stimulation (taVNS), have not yielded promising results. Therefore, the aim of this study was to investigate the effects of the combination of taVNS and RTA on motor impairment, upper extremity motor function, grip strength, daily living characteristics, and

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📋 Eligibility rules (as published)
Inclusion Criteria: * 1\) Individuals aged 18-70 years diagnosed with ischemic or hemorrhagic stroke lasting longer than 6 months, * Moderate to severe upper extremity weakness (20-50 out of 66 on the Fugl-Meyer Upper Extremity Motor Assessment Scale), * Ability to communicate and understand (Mini Mental State Examination (MMSE) score ≥ 23), and 4) Upper extremity spasticity of 2 or less on the Modified Ashworth Scale. Exclusion Criteria: * Use of any stimulation device, such as a pacemaker or other neurostimulator, * Presence of a medical or cognitive condition (personality disorder, anxiety, depression, etc.) that would prevent participants from participating in the study, * Receiving a Botox injection into the affected upper extremity at least 4 weeks prior, * Severe spasticity in the upper extremity (Modified Ashworth Scale ≥3), * Presence of dysphagia or aphasia, * Presence of cardiac problems such as atrial fibrillation, atrial flutter, sick sinus syndrome, or atrioventricular block.
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What it tests

  • Robotics Assisted Education + taVNS
  • Robotics Assisted Education + sham
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Where

1 site
İstanbul Üniversitesi-Cerrahpaşa Sağlık Bilimleri Fakültesi Büyükçekmece Yerleşkesi
Istanbul, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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