Investigation of the Effects of Auricular Vagus Nerve Stimulation Combined With Neurological Physiotherapy and Rehabilitation on Balance, Gait, and Clinical Symptoms in People With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Movement Disorders Society-Unified Parkinson's Disease Rating Scale
研究概览
简要总结
Parkinson's disease (PD) is a progressive, neurodegenerative movement disorder characterized by a combination of motor and non-motor symptoms. Auricular vagus nerve stimulation (aVNS), one of the physiotherapy methods used in PD, has been shown in studies to have a positive effect on symptoms such as motor symptoms, gait disturbance, freezing, and cognitive impairment, and is considered a safe and feasible method. The aim of this study is to investigate the effects of neurological physiotherapy and rehabilitation, in combination with aVNS application, on balance, gait, and clinical symptoms in individuals with PD.
详细描述
Parkinson's disease (PD) is a progressive, neurodegenerative movement disorder characterized by a combination of motor symptoms such as bradykinesia, rigidity, tremor, and postural instability, and non-motor symptoms such as depression, anxiety, and cognitive impairment. Neurological physiotherapy and rehabilitation are among the most important components of PD in the literature to prevent progression, alleviate symptoms, and slow neurodegeneration. Auricular vagus nerve stimulation (aVNS), one of the physiotherapy methods used in PD, has been shown in studies to have a positive effect on symptoms such as motor symptoms, gait disturbance, freezing, and cognitive impairment, and is considered a safe and feasible method. Looking at PD studies in the literature, it is seen that participants applied aVNS at home on their own, in an isolated study design, and individuals were not included in any rehabilitation program. The aim of this study is to investigate the effects of neurological physiotherapy and rehabilitation, in combination with aVNS application, on balance, gait, and clinical symptoms in individuals with PD. The study will include individuals diagnosed with Parkinson's disease. Individuals will be divided into two groups: a control group and a study group. In this blinded study, individuals in both groups will be included in a physiotherapy and rehabilitation program at the Neurological Physiotherapy and Rehabilitation Unit. Individuals in the control group will receive sham aVNS, while individuals in the active treatment group will receive active aNVS. Individuals will be evaluated twice, before and after their three-week, five-day-a-week program. Balance, gait, and clinical symptoms will be assessed using tests and scales.
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)
盲法说明
Participants in the study will not be informed that the vagus nerve stimulation being administered is sham. The physiotherapist responsible for the rehabilitation program will provide the same program to both groups and conduct the evaluations. Participants will not be informed about vagus nerve stimulation. The groups will be blinded to the treatment results, and statistical analyses will be performed by a blind evaluator.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Parkinson's disease confirmed by a neurologist according to the United Kingdom Brain Bank criteria
- •Age 40 years or older
- •Hoehn and Yahr stage between 1 and 3 according to the Modified Hoehn and Yahr Staging Scale
- •Stable pharmacological treatment regimen
- •Ability to turn 180 degrees and walk 30 meters independently without assistance
排除标准
- •Score below 21 on the Montreal Cognitive Assessment (MoCA)
- •Presence of uncorrected visual or hearing impairments
- •Presence of additional neurological (e.g., migraine), orthopedic (e.g., osteoarthritis), or cardiovascular conditions (e.g., myocardial infarction, uncontrolled hypertension, arrhythmias)
- •Presence of a cardiac pacemaker
- •Presence of metallic implants in the head or neck region
- •History of deep brain stimulation surgery
研究组 & 干预措施
Active Auricular Vagus Nerve Stimulation Group
干预措施: Neurological Physiotherapy and Rehabilitation Combined with Active Vagus Nerve Stimua (Other)
Sham Auricular Vagus Nerve Stimulation Group
干预措施: Neurological Physiotherapy and Rehabilitation Combined with Sham Vagus Nerve Stimua (Other)
结局指标
主要结局
Movement Disorders Society-Unified Parkinson's Disease Rating Scale
时间窗: twice: once on the initial assessment day and once after the 3-week program.
The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) was used to assess motor and non-motor symptom severity in individuals with Parkinson's disease. The MDS-UPDRS is a validated, comprehensive clinical rating scale consisting of four parts: non-motor experiences of daily living (Part I), motor experiences of daily living (Part II), motor examination (Part III), and motor complications (Part IV). Higher scores indicate greater symptom severity. The scale has demonstrated excellent reliability, validity, and sensitivity to change in clinical trials and is widely recommended as a primary outcome measure in Parkinson's disease research.
Postural Stability
时间窗: twice: once on the initial assessment day and once after the 3-week program.
The force platform, considered the gold standard for the quantitative assessment of postural stability, is a valid and reliable method that enables objective evaluation of balance. In this study, postural stability during quiet standing will be assessed using a force platform. Participants will stand on the platform in a standardized foot position, with their arms at their sides and their gaze fixed forward. Measurements will be performed under eyes-open and eyes-closed conditions. For each condition, trials of fixed duration will be recorded, and center of pressure (CoP) parameter will be calculated. Higher CoP value will indicate reduced postural stability. Measurements will be repeated according to a standardized protocol, and the average values will be used for analysis.
Spatiotemporal Gait Parameters
时间窗: twice: once on the initial assessment day and once after the 3-week program.
Spatiotemporal gait characteristics will be evaluated using a gait analysis system. Participants will walk across the walkway six times at their self-selected comfortable speed. Temporal and spatial parameters (step length, stride length, step time, stride time, double support time) of gait, as well as variability measures, will be calculated.
Functional Walking Capacity
时间窗: twice: once on the initial assessment day and once after the 3-week program.
Functional walking capacity will be assessed using the 6-Minute Walk Test (6MWT). Participants will be instructed to walk as far as possible within six minutes along a standardized walkway. The total distance covered will be recorded in meters. In individuals with Parkinson's disease, the minimal clinically important difference has been reported as 82 meters.
次要结局
- Berg Balance Sclae(twice: once on the initial assessment day and once after the 3-week program.)
- Activities-specific Balance Confidence Scale(twice: once on the initial assessment day and once after the 3-week program.)
- Functional Mobility(twice: once on the initial assessment day and once after the 3-week program.)
- Trail Making Test(twice: once on the initial assessment day and once after the 3-week program.)
- Stroop Test(twice: once on the initial assessment day and once after the 3-week program.)
- Quality of Life Assessment(twice: once on the initial assessment day and once after the 3-week program.)
- Fatigue Assessment(twice: once on the initial assessment day and once after the 3-week program.)
研究者
Mustafa Can Salamci
Principal Investigator
Gazi University