The Effects of Different Vibro-tactile Stimulation Intensities on Head Posture in Cervical Dystonia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Head Angle Index
研究概览
简要总结
The primary goal of this clinical trial is to examine the effects of cervical vibrotactile stimulation intensity on abnormal head posture in people with cervical dystonia. The main question is: Does higher vibration intensity correct head posture to a greater extent than lower vibration intensity? Researchers will compare the head posture of participants with cervical dystonia who receive different intensities of vibration to cervical muscles.
The secondary goal of this clinical trial is to examine the degree of proprioceptive impairment in cervical dystonia. Specifically, the study will assess proprioceptive impairment at the neck, wrist, and ankle joints, and seeks to determine whether the impairment improves with cervical vibrotactile stimulation.
Researchers will compare the proprioception testing results of these joints between cervical dystonia patients and age- and sex- matched healthy controls. Researchers will also compare the neck proprioception testing results of cervical dystonia patients before and after stimulation.
Participants will visit the lab once for three hours, where they will go through:
- clinical questionnaires;
- neck, wrist, and ankle proprioception testing,
- vibrotactile stimulation where they sit and relax
- neck proprioception testing
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Confirmed diagnosis of adult-onset, isolated idiopathic cervical dystonia.
排除标准
- •History of other neurological diseases, including Parkinson's disease, essential tremor, dementia, etc.
- •History of peripheral nervous system disease that can impair proprioception. Deep brain stimulation implanted or denervation surgery. UBACC score lower than
- •Severe head tremors or facial muscle contractions. Regular intake of benzodiazepines or antidepressant medication.
研究组 & 干预措施
Healthy Controls
Healthy people age- and sex- matched with participants with cervical dystonia will be in this group. This group will only be tested on their neck, wrist, and ankle proprioception, to compare with the cervical dystonia group.
Cervical Dystonia Group
All participants with cervical dystonia will be in this group to receive the intervention. After answer three questionnaires (The Mini Mental State Examination, the Revised Toronto Western Spasmodic Torticollis Rating Scale and Psychiatric Screening Tool, Fahn, Tolosa, Marin Tremor Rating Scale), their neck, wrist, and ankle proprioception will be tested respectively. They they will go through the intervention of cervical vibrotactile stimulation. Lastly, their neck proprioception will be tested again.
干预措施: cervical vibrotactile stimulation (Device)
结局指标
主要结局
Head Angle Index
时间窗: As part of the one-time visit, this part will take 90 minutes.
The primary outcome measure is the head angle index, which quantifies how much a participant's head posture deviates from a neutral upright position. There are three degrees of freedom for the neck joint (axial rotation, lateral bending, and flexion/extension). For each participant, the degree(s) of freedom with abnormality will be identified at baseline. For any time period during the experiment, the mean absolute neck angle in each abnormal degree of freedom will be calculated and normalized by the typical maximal range of motion in healthy individuals. These normalized values will be averaged to yield the Head Angle Index.
次要结局
- Position Matching Error(As part of the one-time visit, this part will take 60 minutes.)
- the Toronto Western Spasmodic Torticollis Rating Scale Score(As part of this one-time visit, 10 minutes.)
- Fahn-Tolosa-Marin Clinical Rating Scale Score(As part of a one-time visit, 10 minutes.)