Effects of Vagus Nerve Stimulation on Motor Function, Respiratory Muscle Strength, and Quality of Life 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
Stroke is one of the leading causes of death and permanent disability worldwide. Loss of upper extremity (UE) function after stroke significantly reduces independence and quality of life. Moreover, weakness in the respiratory muscles negatively affects trunk control and respiratory function, limiting overall functional recovery. In recent years, robot-assisted training (RAT) and non-invasive neuromodulation techniques-particularly transcutaneous auricular vagus nerve stimulation (taVNS)-have emerged as promising approaches to enhance neuroplasticity in stroke rehabilitation.
This study aims to investigate the effects of taVNS combined with robot-assisted training on upper extremity motor function, respiratory muscle strength, and quality of life in individuals with stroke.
This randomized controlled trial will be conducted in collaboration between Istanbul University-Cerrahpaşa and Istanbul Medeniyet University. Thirty individuals aged 18-70 years, with moderate-to-severe upper extremity weakness and a history of stroke of at least six months, will be included. Participants will be randomly assigned to two groups: RAT + taVNS (n=15), RAT + sham taVNS (n=15). Both groups will receive conventional rehabilitation for 45 minutes, three times per week for five weeks. Additionally, each group will undergo 45-minute sessions of RAT twice per week for five weeks, with either active or sham taVNS applied concurrently.
The primary outcome measure will be the Fugl-Meyer Upper Extremity Motor Assessment (FM-UE). Secondary outcomes will include the Stroke Impact Scale (SIS), Maximum Inspiratory Pressure (MIP), Maximum Expiratory Pressure (MEP), and Fatigue Assessment Scale (FAS). Assessments will be conducted at baseline and at the end of the fifth week.
Combining taVNS with robot-assisted upper extremity rehabilitation is expected to result in greater improvements in motor function, respiratory muscle strength, and quality of life compared to robot-assisted rehabilitation alone. This study will provide valuable insights into the synergistic effects of neuromodulation and robotic therapy in stroke rehabilitation and contribute to the growing body of evidence supporting non-invasive, technology-assisted treatment approaches.
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
- None
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
- •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),
- •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 + sham
干预措施: Robotics Assisted Education + sham (Other)
Robotics Assisted Education + taVNS
干预措施: Robotics Assisted Education + taVNS (Device)
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.
次要结局
- Stroke Impact Scale (SIS)(Outcome measures will be assessed and recorded at baseline (assessment session) and after intervention (week 5).)
- Maximum Inspiratory Pressure (MIP)(Outcome measures will be assessed and recorded at baseline (assessment session) and after intervention (week 5).)
- Maximum Expiratory Pressure (MEP)(Outcome measures will be assessed and recorded at baseline (assessment session) and after intervention (week 5).)
- Fatigue Assessment Scale(FAS)(Outcome measures will be assessed and recorded at baseline (assessment session) and after intervention (week 5).)
研究者
Yusuf AÇIKGÖZ
Principal Investigator
Istanbul University - Cerrahpasa