An interventional study of Robotic Rehabilitation and Transcutaneous Auricular Vagal Nerve Stimulation in Ischemic Stroke, Vagus Nerve Stimulation and Robotic Rehabilitation, sponsored by SEFA HAKTAN HATIK. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-24.
Sponsored by SEFA HAKTAN HATIK · Not applicable, Interventional, and Treatment
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.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 40 is below the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →SEFA HAKTAN HATIK is the lead sponsor of 14 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
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.
Device: Robotic Rehabilitation
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.
Device: Robotic Rehabilitation · Device: Transcutaneous Auricular Vagal Nerve Stimulation
Lokomat is an exoskeleton type robotic walking device that can support both extremities symmetrically.
Vagus nerve stimulation is defined as any technique that stimulates the vagus nerve in our body.
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: 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: 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: 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: 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: 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.
Time frame: 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: Time Frame: within 10 minutes after intervention
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