Transcranial Vibrating System for Improving Outcomes of Vestibular Physical Therapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Change in duration of the vestibular physical therapy exercise session
研究概览
简要总结
This research study aims to determine whether low-frequency transcranial vibrations can act as a possible treatment for the dizziness and nausea often associated with vestibular physical therapy.
详细描述
The purpose of this study is to determine the effectiveness of a Transcranial Vibration System (TCVS) at reducing the increased nausea and discomfort sometimes associated with vestibular physical therapy. The TCVS is a small device attached to an elastic band. It is worn around the head and produces vibrations. There is no implant or surgical procedure. The FDA has made a pre-determination that this is a low-risk device (a "Class 2 device" in FDA terminology).
The TCVS has previously been tested in healthy volunteers and has been found to safely and effectively decrease dizziness and nausea associated with vestibular discomfort. This study will expand that research to vestibular disorder patients who are undergoing physical therapy. The study compares the outcomes to not wearing a device, or to a control (inneffective) device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Arm 1: their will be no masking as the participants will either wear the transcranial vibrating system (TCVS) or not.
Arm 2: the investigators will be provided 2 TCVS by the sponsor, labeled A or B, which will be randomly assigned to participants by the sponsor. One TCVS will be set at the optimal vibration frequency and the other TCVS will be set at an irrelevant vibration frequency (sham). The investigators and the participants will not know which TCVS is optimal or sham, thus the arm 2 will be double blinded.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •reluctant or unable to perform a full session of vestibular physical therapy
排除标准
- •History of head injury within the last six months or currently suffering the effects of a head injury (i.e. concussion or traumatic brain injury)
- •Presence of severe aphasia.
- •History of diagnosed neuropsychiatric disorders (e.g. hypochondriasis, major depression, schizophrenia).
- •Documented neurodegenerative disorders.
- •Pregnancy Female candidates will be asked to take a pregnancy test first and will have to make a informed decision to participate based on the results of the pregnancy test.
- •History of Cerebrovascular disorders.
- •History of ear operation other than myringotomy and tube placement in the past.
- •Systemic disorders to include chronic renal failure, cirrhosis of the liver, autoimmune disease, heart disease, lung disease, or severe arthritis.
研究组 & 干预措施
Vs transcranial vibrating system sham
40 participants will be enrolled for a 4 week period and will have 2 vestibular physical therapy (PT) visits per week. Participants will perform their PT exercises (30 minutes or less if the participant is too dizzy to finish) wearing the transcranial vibration system (TCVS) at optimal vibrating frequency or wearing the TCVS at irrelevant vibrating frequency (sham). The TCVS and TCVS sham will be labeled A or B by the sponsor. The investigators and participants will not know which TCVS is optimal or sham. The sponsor will randomly assign participants TCVS A or B.
Outcomes measured:
- at every visit: dizziness at the end of PT exercise (with dizziness symptom scale DSS); duration of PT exercise
- at the first and last visit: force plate system assessment (balance)
干预措施: Transcranial vibrating system (Device)
Vs transcranial vibrating system sham
40 participants will be enrolled for a 4 week period and will have 2 vestibular physical therapy (PT) visits per week. Participants will perform their PT exercises (30 minutes or less if the participant is too dizzy to finish) wearing the transcranial vibration system (TCVS) at optimal vibrating frequency or wearing the TCVS at irrelevant vibrating frequency (sham). The TCVS and TCVS sham will be labeled A or B by the sponsor. The investigators and participants will not know which TCVS is optimal or sham. The sponsor will randomly assign participants TCVS A or B.
Outcomes measured:
- at every visit: dizziness at the end of PT exercise (with dizziness symptom scale DSS); duration of PT exercise
- at the first and last visit: force plate system assessment (balance)
干预措施: Transcranial vibrating system sham (Device)
Transcranial vibrating system effect
Participants will be enrolled for a 4 week period and will have 2 vestibular physical therapy (PT) visits per week. During the first 2 weeks (4 visits), 20 participants will perform their PT exercises (30 minutes or less if the participant is too dizzy to finish) wearing the transcranial vibration system (TCVS) and the other 20 participants without. The following 2 consecutive weeks (4 visits), participants will perform their PT exercises wearing the TCVS if they weren't previously, or won't wear the device during their PT exercises if they were previously.
Outcomes measured:
- at every visit: dizziness at the end of PT exercise (with dizziness symptom scale DSS); duration of PT exercise
- at the first and last visit: force plate system assessment (balance)
干预措施: Transcranial vibrating system (Device)
结局指标
主要结局
Change in duration of the vestibular physical therapy exercise session
时间窗: up to 30 minutes
The participants will perform vestibular physical therapy exercises for 30 minutes unless their dizziness symptoms prevend them to finish. The change in vestibular physical therapy exercises they can perform will be recorded by the investigator. This value will be recorded immediately after they finish their physical therapy exercises.
Change in dizziness index
时间窗: Questionaire immediately after the end of physical therapy exercise
The dizziness index will be evaluated with the Dizziness Symptom Scale (DSS) with a scale from 1 (no dizziness) to 10 (strong dizziness). The change of DSS will be evaluated between participants wearing: * the transcranial vibrating system (TCVS) * no TCVS * the TCVS sham
Change in balance
时间窗: During first and last vestibular physical therapy visit; expected duration maximum 10 minutes
Participant's balance will be evaluated with a force plate platform (Bertec Device). Participants will be placed on the plate 1. eyes open, 2. eyes closed, 3. eyes open while standing on a foam pad, 4. eyes closed while standing on a foam pad. Each of the 4 conditions will involve the participant standing barefoot on a force plate platform for 10 seconds. The change in participant's balance (X\&Y direction) will be assessed by recording values of the Bertec device in two conditions: first with participants not wearing the TCVS and second with participants wearing the TCVS at optimal vibration frequency or wearing the TCVS sham. Clinical parameters obtained from the Bertec system will be recorded, including "falls" and will be compared between conditions to evaluate participant's change in balance. Participants will always be held safe with a harness secured to a mount point in the ceiling.
次要结局
未报告次要终点