The Effect of Robotic Rehabilitation and Vagus Nerve Stimulation in Addition to Robotic Rehabilitation on the Patient's Functional Level and Autonomic Nervous System in Patients With Ischemic Stroke
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 主要终点
- Stroke Specific Quality of Life Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being diagnosed with ischemic stroke
- •Having a stroke for the first time
- •Having hemiparesis
- •≤ 6 months after stroke
- •Being able to walk with or without support
- •Understanding and focusing on Lokomat exercises and being able to do them
- •Having received walking training with Lokomat in our hospital
- •Having signed the voluntary consent form
- •Being over 18 years of age
排除标准
- •Body weight more than 135 kg
- •The person's height is more than two meters
- •Femur length outside the range of 35-47 cm
- •Intolerable leg length differences
- •Peripheral nerve injury
- •Peripheral neuropathy
- •Anticholinergic drug use
- •Presence of skin lesions
- •Spasticity that prevents the locomotive from working
- •Having diagnosed psychiatric problems
- •Severe contracture in lower extremity muscles
- •Not being able to walk before stroke
- •Having a history of additional neurological diseases (Parkinson, etc.)
- •Unstable cardio-pulmonary disease
- •Having orthopedic fractures (lower extremity fractures) and/or joint implants
- •Severe osteoporosis
- •Uncontrolled hypertension despite medication use
- •Lower extremity amputation
结局指标
主要结局
Stroke Specific Quality of Life Scale
时间窗: Time Frame: within 10 minutes after intervention
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.
Numerical Pain Rating Scale
时间窗: Time Frame: within 10 minutes after intervention
Numerical pain scale is used to classify pain from 0 to 10. '0' means no pain and '10' means unbearable pain.
10 Meter Walk Test
时间窗: Time Frame: within 10 minutes after intervention
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.
Fugl-Meyer Assessment Lower Extremity
时间窗: Time Frame: within 10 minutes after intervention
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.
Modified Ashworth Scale
时间窗: Time Frame: within 10 minutes after intervention
It is the universally accepted clinical tool used to measure increases in muscle tone.
Electromyography
时间窗: Time Frame: within 10 minutes after intervention
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.
Autonomic Nervous System
时间窗: Time Frame: within 10 minutes after intervention
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.
次要结局
未报告次要终点
研究者
SEFA HAKTAN HATIK
Assistant Professor
Sinop University