Vibration Impact on Parkinson's Tremor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS)
研究概览
简要总结
The primary purpose of this study is to test the safety, tolerability and efficacy of vibration (delivered by an experimental device called RMBand that is worn on the subject's arm) on parkinsonian tremor. The RMBand was developed by Resonate Forward, LLC (RF). This RMBand is designed to administer a vibration to the wearer to decrease or stop tremor in persons with Parkinson's disease (PD).
详细描述
Participation will be completed in one visit at VCU Parkinson's and Movement Disorders Center. A baseline Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) will be taken prior to vibration therapy. The RMBand (experimental device) will be placed on the arm of the participant to provide the vibration therapy. The MDS-UPDRS Part III will be repeated both during and after the therapy. Participants will be asked to provide feedback about the device, the therapy session and how they are feeling.
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)
入排标准
- 年龄范围
- 21 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parkinson's disease (PD) as diagnosed by a movement disorder specialist
- •Tremor caused by their Parkinson's disease
- •Ability to provide informed consent
排除标准
- •Known diagnosis of Parkinson Plus Syndrome
- •Other known non-PD cause of tremor
- •Other known non-PD cause of limb dysfunction
- •Presence of implantable cardiac device, severe neuropathy or sensory loss that would prevent perception of vibration stimulus
- •Non-English speaker
- •Prisoners
- •Pregnant women
结局指标
主要结局
Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS)
时间窗: This rating scale will be used at baseline, 5 minutes after vibration starts, and 5 minutes after vibration is turned off.
The "Movement Disorder Society Unified Parkinson Disease Rating Scale" (MDS-UPDRS) Part III, only, will be used at baseline, and repeated during vibration and post vibration data collection times. It is a validated scale administered by a clinician, contains 34 items to score between 0 (normal) and 4 (severe). The score range is 0 - 136. It takes \~ 5 minutes to complete. Lower scores are better. This outcome measure will be used to report a change in PD motor symptoms over time.
Clinical Rating for Tremor
时间窗: Data collection times were baseline, 5 minutes after vibration start (vibration duration was 20 minutes), 5 minutes after vibration was stopped. .
Clinical Rating Scale for Tremor (Fahn, Tolosa, \& Marin) assesses severity of tremor symptoms. This scale takes 10-minutes, Items 1 - 14 will be used to report average changes in tremor. Items are rated on a scale of 0=normal to 4=severely abnormal, total summative score range for items 1- 14 points is 0 - 56. Lower scores are better. Total time to complete the Scale for Tremor assessment is 10 minutes.
Objective Measurement of Tremor Frequency (Hz)
时间窗: Five minutes before vibration is turned on, throughout vibration treatment, and approximately five minutes post treatment.
This is a device that will objectively measure tremors frequency and amplitude pre, during, and post treatment.
Objective Measurement of Tremor Amplitude (mm).
时间窗: Five minutes before vibration is turned on, throughout vibration treatment, and approximately five minutes post treatment.
This is a device that will objectively measure tremor amplitude pre, during, and post treatment.
次要结局
未报告次要终点