Optimizing Vibrational Therapy to Improve Gait and Balance in Parkinson's Disease - Phase 1
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Functional Ambulation Profile (FAP) Score
研究概览
简要总结
The purpose of this research study is to determine optimum dose of vibration delivered by an experimental device called PDVibe2 required to treat freezing of gait in persons with Parkinson's disease (PD). The PDVibe2 was developed by Resonate Forward, LLC (RF). This PDVibe2 was designed to administer vibration therapy to the wearer to improve gait and balance in persons with PD while wearing the device.
详细描述
Participation will require up to 8 treatment sessions within 5 days (no more than 2 sessions in one day) plus an additional day for screening and another for follow-up (7 days total). All visits will occur at the Virginia Commonwealth University Parkinson's Movement and Disorders Center in Richmond, VA. Participants will be asked to walk for a brief period of time while wearing the PDVibe2. The PDVibe2 will provide vibration therapy and study staff will measure the number of "freezes" before, during and after therapy. Participants will be asked to provide feedback on 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
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Investigators and outcomes assessors will be blinded to the dose of vibration randomly assigned to participants.
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
- 未提供
排除标准
- •diagnosed with a known Parkinson plus syndrome
- •were previously exposed to vibration treatment for gait and balance
- •presence of dementia (Montreal Cognitive Assessment < 21)
- •additional disorders (not related to PD)impairing gait, stance, balance or coordination (e.g. stroke, leg amputations, or multiple sclerosis)
- •history of implantable cardiac device or any other implanted electronic device except a deep brain stimulator (DBS)
- •use of braces/orthotics that assist with walking
- •are currently in physical therapy (PT) treatment for balance or gait
- •peripheral neuropathy by exam
- •any condition that, in the opinion of the PIs, would compromise participant safety, data integrity, or data interpretation.
- •Children under the age of 18
- •Prisoners
- •Women who are pregnant or may become pregnant during the course of this study since the safety of this device for an unborn child is unknown.
研究组 & 干预措施
Setting 1
PDVibe2 set to high frequency and low amplitude
干预措施: PDVibe2 (Device)
Setting 2
PDVibe2 set to high frequency and medium amplitude
干预措施: PDVibe2 (Device)
Setting 3
PDVibe2 set to high frequency and high amplitude
干预措施: PDVibe2 (Device)
Setting 4
PDVibe2 set to medium frequency and low amplitude
干预措施: PDVibe2 (Device)
Setting 5
PDVibe2 set to medium frequency and medium amplitude
干预措施: PDVibe2 (Device)
Setting 6
PDVibe2 set to medium frequency and high amplitude
干预措施: PDVibe2 (Device)
Setting 7
PDVibe2 set to low frequency and low amplitude
干预措施: PDVibe2 (Device)
Setting 8
PDVibe2 set to low frequency and medium amplitude
干预措施: PDVibe2 (Device)
Setting 9
PDVibe2 set to low frequency and high amplitude
干预措施: PDVibe2 (Device)
结局指标
主要结局
Functional Ambulation Profile (FAP) Score
时间窗: Throughout study completion, from 9 to 34 days.
The FAP score is the gold standard for spatiotemporal gait parameter analysis. For this study, it will be calculated by participants walking on the Zeno walkway, which will measure the patient's physical measurements, step length, step time and degree of symmetry.Step length, step time, degree of symmetry, dynamic base of support and the use of ambulatory aids are factored into the score. The Zeno instrumented walkway (PKMAS) is a 20-foot computerized instrumented walkway containing sensor pads.
次要结局
- Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) Part III(Throughout study completion, between 9 to 34 days.)
- Berg Balance Scale(Throughout study completion, between 9 to 34 days.)
- Freezing of Gait Questionnaire(Throughout study completion, between 9 to 34 days)
- Fall Efficacy Scale - International(Throughout study completion, between 9 to 34 days.)
- Timed Up and Go Test(Throughout study completion, between 9 to 34 days.)
- Parkinson's Disease Questionnaire - 39(Throughout study completion, between 9 to 34 days.)