The Effects of Vibrotactile Stimulation (Not Impossible Vibrohealth) on Motor Control and Symptoms in Patients With Movement Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Quantitative Tremor Assessment
研究概览
简要总结
Vibration applied to the skin has been anecdotally reported to potentially improve motor control in patients with movement disorders including Parkinson's disease, however few devices have been studied formally. In this study, the investigators will test the effect of skin surface vibration applied non-invasively to patients with movement disorders to determine if there are any beneficial effects on common tasks of motor control and/or abnormal motor symptoms in patients with Parkinson's disease (PD), essential tremor (ET), and dystonia.
详细描述
This study is to evaluate the feasibility, reliability, and clinical effects of Non-invasive vibrotactile stimulation (VTS) on basic tasks of motor control and on the motor symptoms of patients with movement disorders. VTS Settings will include continuous stimulation, intermittent stimulation during walking, and sham stimulation.
The investigators will recruit 30 patients with PD who are between the ages of 18-80 years old and independently living in the community. The investigators will additionally recruit up to 5 patients with ET and up to 5 patients with dystonia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The research subjects will be blinded regarding stimulation or sham and specific stimulation settings. Walking will be scored by a blinded rater for number of freezing episodes and walking completion time in seconds in the timed up and go task.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 and able to provide informed consent.
- •Have a diagnosis of Parkinson's disease, essential tremor, or cervical dystonia made by a movement disorders specialist.
- •Medically optimized without planned medication changes for the duration of the study.
- •For patients with ET, they will have a score of at least 2 on items 5 and 6 of the Fahn-Tolosa-Marin (FTM) Tremor Rating Scale.
- •For patients with dystonia, they will have abnormal dystonic postures of the head and not isolated head tremor
排除标准
- •The presence of additional neurologic diseases, that might confound testing or the coexistence of PD and ET together (action tremor that was present prior to the development of parkinsonism).
- •Symptoms of peripheral neuropathy at the wrist (reduced vibratory, pinprick, or temperature sensation)
- •Montreal cognitive assessment (MoCA) score < 20 or previously documented dementia
- •Unable to walk without a walking aid (e.g. cane, stick, walker)
结局指标
主要结局
Quantitative Tremor Assessment
时间窗: Baseline up to immediately after the sham intervention
An external accelerometer will be adhered to the skin of the dorsum of the hand and will be used to quantify displacement of the hand due to tremor in the following conditions: * 1\. Sitting at rest * 2\. Sitting with both arms outstretched * 3\. Sitting at rest while performing a distracting cognitive task * 4\. Transition from rest to posture (arms held directly in front of patient) for 10 seconds
次要结局
- Functional Dexterity Task (FDT)(Baseline up to immediately after the sham intervention)
- Timed-up-and-go (TUG) gait task(Baseline up to immediately after the sham intervention)
- Reaction time task(Baseline up to immediately after the sham intervention)