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This study was conducted in patients with ischemic stroke; This study was conducted to examine the effect of robotic rehabilitation and transcutaneous auricular vagal nerve stimulation applied in addition to robotic rehabilitation on the patient's functional level and autonomic nervous system.
40 people over the age of 18 participated in the study. They were randomly divided into two groups: robotic rehabilitation and transcutaneous auricular vagal nerve stimulation applied in addition to robotic rehabilitation. While the robotic rehabilitation group received Lokomat and neurological rehabilitation, the other group received stimulation with the Vagustim device, which is applied non-invasively through the ear, in addition to Lokomat and neurological rehabilitation. Spasticity, autonomic nervous system, walking speed, motor function, quality of life, muscle activity and pain were evaluated in both groups before starting treatment and six weeks after treatment. In the study, significance was evaluated at p<0.05 level.
A study group was formed, consisting of individuals who had an ischemic stroke over the age of 18, who complied with the research criteria and who signed the voluntary consent form. Age, gender, height, weight, body mass index, dominant side, affected side and time since stroke of the participants who met the inclusion criteria were recorded and randomly divided into 2 groups.
The groups are; They were divided into Robotic Rehabilitation (RRG) (n=20, 11 women, 9 men) and Transcutaneous Auricular Vagal Nerve Stimulation (VRRG) applied in addition to Robotic Rehabilitation (n=20, 9 women, 11 men) groups.
A 6-week protocol was applied in the study. In addition to the neurological rehabilitation program, robotic rehabilitation was applied to the RRG group 2 days a week. In addition to the neurological rehabilitation program, both robotic rehabilitation and transcutaneous auricular vagal nerve stimulation were applied to the VRRG group 2 days a week. Some evaluations were made by the researcher at two different time periods throughout the study. Evaluation times; T0 (before robotic rehabilitation/vagal nerve stimulation application in addition to robotic rehabilitation), T1 (robotic rehabilitation/after vagal nerve stimulation application applied in addition to robotic rehabilitation). These time periods were planned and carried out immediately before the study and after 6 weeks of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic Rehabilitation Group (RRG) | Experimental | A 6-week protocol will be applied in the study. In addition to the neurological rehabilitation program, robotic rehabilitation will be applied to the RRG group 2 days a week. Some evaluations will be made by the researcher at two different time periods throughout the study. These time periods will be planned and carried out immediately before the study and after the 6-week treatment. |
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| Vagal Nerve Stimulation With Robotic Rehabilitation Group (VRRG) | Experimental | In addition to the neurological rehabilitation program, the VRRG group will receive both robotic rehabilitation and t-VNS 2 days a week. Some evaluations will be made by the researcher at two different time periods throughout the study. These time periods will be planned and carried out immediately before the study and after the 6-week treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic Rehabilitation | Device | Lokomat is an exoskeleton type robotic walking device that can support both extremities symmetrically. |
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| Measure | Description | Time Frame |
|---|---|---|
| Numerical Pain Rating Scale | Numerical pain scale is used to classify pain from 0 to 10. '0' means no pain and '10' means unbearable pain. | Time Frame: within 10 minutes after intervention |
| Stroke Specific Quality of Life Scale | The stroke-specific quality of life scale consists of a total of 49 items in 12 domains. Each item is scored between 1 (strongly agree) and 5 (strongly disagree). The total score is evaluated between 49 and 245 points. A score of 49 indicates the lowest quality of life and 245 indicates the highest quality of life. | Time Frame: within 10 minutes after intervention |
| 10 Meter Walk Test | During the test, the patient's walking performance is recorded in terms of time between two markers located 10 meters apart. It is used to determine functional mobility and walking speed. | Time Frame: within 10 minutes after intervention |
| Fugl-Meyer Assessment Lower Extremity | It is a widely used scale in the evaluation of motor function after stroke. The lower extremity section consists of 17 items and its maximum score is 34 points. | Time Frame: within 10 minutes after intervention |
| Modified Ashworth Scale | It is the universally accepted clinical tool used to measure increases in muscle tone. | Time Frame: within 10 minutes after intervention |
| Electromyography | It refers to the collective electrical signals during the contraction of muscles connected to the nervous system. EMG devices evaluate and interpret the electrical potential that enables the contraction of voluntary muscles. The EMG device evaluates voluntarily working skeletal muscles. EMG, a muscle examination, monitors and interprets the electrical activity that causes muscles to contract. EMG examinations are defined as a set of tests that include nerve examination as well as examination of muscle activation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sefa Haktan HATIK, PhD | Contact | 00905058761533 | haktanhtk@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| SEFA HAKTAN HATIK, PhD | Sinop University | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41742071 | Derived | Kizil OD, Ural IH, Hatik SH, Ozden AV, Aydin EB. Effects of transcutaneous auricular vagus nerve stimulation added to robotic rehabilitation in patients with ischemic stroke: a randomized clinical trial. BMC Neurol. 2026 Feb 25;26(1):213. doi: 10.1186/s12883-026-04743-6. |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Transcutaneous Auricular Vagal Nerve Stimulation | Device | Vagus nerve stimulation is defined as any technique that stimulates the vagus nerve in our body. |
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| Time Frame: within 10 minutes after intervention |
| Autonomic Nervous System | The Polar H10 device is a gold-standard HRV sensor of high sensitivity and accuracy that comes with a wearable chest strap. The device comes with a soft, adjustable sensor that contacts the chest to capture HRV in real time. | Time Frame: within 10 minutes after intervention |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |