Evaluating the Effects of a Removable Dental Mouthpiece on Symptoms Associated With Parkinson's
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Changes in Mini-Balance Evaluation Systems Test (Mini-BESTest)
研究概览
简要总结
The investigators are evaluating the immediate effect of a dental mouthpiece on gait and balance among people with Parkinson disease as well as longer-term feasibility use and the effect of the mouthpiece on sleep and quality of life.
详细描述
The investigators are conducting a pilot study with participants who have been diagnosed with Parkinson disease recruited from the community. Participants will attend one in-person visit and be custom fitted with a dental mouthpiece. Participants will be asked to wear the mouthpiece as much as possible for one month including while sleeping and during the day, except while eating.
Participants will be asked to return for a second in-person visit to repeat gait and balance (motor) measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 否
入选标准
- •have a diagnosis of idiopathic, typical Parkinson Disease according to the United Kingdom Brain Bank Criteria, Hoehn & Yahr stages 1-3;
- •stable Parkinson disease medications for the two weeks prior to baseline visit;
- •be able to walk at least 10 meters at baseline with or without an assistive device;
- •have their own teeth and/or dentures;
- •be willing to try to wear a mouthpiece for one month;
- •are over the age of 30; and
- •provide written or verbal informed consent.
排除标准
- •pre-existing medical conditions that would inhibit full participation in the study's tasks;
- •absence of any dentition;
- •cognitive impairments indicated by Mini Mental Status Exam (MMSE) score of <24;
- •freezing of gait which moderately or severely impacts walking; or
- •current use of an oral appliance (e.g., a dental mouthpiece, retainer, or braces).
结局指标
主要结局
Changes in Mini-Balance Evaluation Systems Test (Mini-BESTest)
时间窗: Baseline in-person visit
Balance will be measured with the Mini-Balance Evaluation Systems Test (Mini-BESTest) with and without the mouthpiece. The assessment includes 14 items each of which is rated on a three-point scale (2: Normal, 1: Moderate, 0: Severe). The 14 item scores are summed for a total score. The range of scores is 0 to 28, and higher scores indicate better balance function.
Changes in Gait Velocity
时间窗: Baseline in-person visit
Gait velocity will be measured while walking forwards with and without the mouthpiece
次要结局
- Changes in Parkinson Disease Questionnaire-39(Baseline and One month)
- Changes in Parkinson Disease Sleep Scale(Baseline and One month)
研究者
Gammon M Earhart
Director, Program in Physical Therapy
Washington University School of Medicine