Effect of Transcutaneous Auricular Vagus Nerve Stimulation Combined With Upper Extremity Robot-Assisted Training on Upper Extremity Motor Functions in Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Fugl Meyer Upper Extremity Evaluation (FM-UE)
研究概览
简要总结
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 quality of life in individuals with stroke. Stroke medications were randomly assigned to RDE+taVNS (n=15) and RDE+sham taVNS (n=15). All participants will receive conventional treatment for 45 minutes per day, 3 days per week, for 5 weeks. One group will also receive RDE+taVNS treatment for 45 minutes per day, 2 days per week, for 5 weeks, while the other group will receive RDE+sha taVNS. Participants will be assessed using the Fugl-Meyer Upper Extremity Assessment, ARAT (Action Research Arm Test), and Box and Block Test as primary outcomes at baseline and after 5 weeks.
This project will contribute to the literature by demonstrating the effectiveness of taVNS, one of the most promising methods available. Furthermore, the results will prompt discussion on the applicability of the method not only to stroke patients but also to other disease groups. The unique value of this project is that it is the first study to investigate product improvements in taVNS systems.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Robotics Assisted Education + taVNS
干预措施: Robotics Assisted Education + taVNS (Device)
Robotics Assisted Education + sham
干预措施: Robotics Assisted Education + sham (Other)
结局指标
主要结局
Fugl Meyer Upper Extremity Evaluation (FM-UE)
时间窗: Outcome measures will be assessed and recorded at baseline (assessment session) and after intervention (week 5).
We will use the Fugl-Meyer Upper Motor Assessment score, which is the most sensitive for treatment outcomes in stroke patients presenting with unilateral paresis in the post-stroke period. It measures upper extremity use and impairment, measuring shoulder, elbow, forearm, wrist, finger, and reflex movements from proximal to distal, synergistic to extrinsic. The score ranges from 0 to 66 and consists of 33 items. 0-28 indicates severe motor impairment; 29-42 indicates moderate motor impairment; and 43-66 indicates mild motor impairment. Higher scores indicate better performance. The FM-UE consists of one component, each rated on a 3-point ordinal scale (0=not achieved, 1=partially contributed, 2=completely contributed). The minimum clinically meaningful change on the FM-UE for chronic stroke has been determined to be 4.25 to 7.25. Consistent with the literature, we define an improvement of at least 6 points or more as significant.
Box and Block Test (BBT)
时间窗: Outcome measures will be assessed and recorded at baseline (assessment session) and after intervention (week 5).
The Box and Block Test is a manual dexterity test used to assess upper extremity motor function. It primarily assesses gross motor function. It is calculated by the number of 2.5 cm3 blocks thrown from one side to the other in 1 minute. A box and block test kit has been prepared to meet international standards.
次要结局
- Hand Grip Strength(Outcome measures will be assessed and recorded at baseline (assessment session) and after intervention (week 5).)
- Stroke Impact Scale (SIS)(Outcome measures will be assessed and recorded at baseline (assessment session) and after intervention (week 5).)
研究者
rustem mustafaoglu
associate professor
Istanbul University - Cerrahpasa