Treatment of Balance Disorders in Parkinson's Patients Using SpotOn Balance Glasses
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Freeze of gait (FOG) Questionnaire
研究概览
简要总结
An open-label study to evaluate the effect of SpotOn balance glasses in non-demented Parkinson's patients with balance disorders.
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
- •Female or men
- •Diagnosed with Parkinson's disease (according to Brain Bank UK criteria)
- •Non-demented
- •Age: ≥ 30 years
- •Gait disturbances
- •Patients who are able to perform questionnaires and physical tests (including computerized tests)
- •Gave informed consent for participation in the study
排除标准
- •Unstable (less than 1 month) use of concomitant medications that might affect the balance system
- •Change of PD medications during the past month
- •Any medical condition or disorder that could produce gait or balance disturbances unless well controlled for at least 3 months
- •Currently taking part in a clinical trial or within 30 days prior to screening
- •Any known condition which in the opinion of the investigator may impair gait or balance and/or limits the successful trial completion
结局指标
主要结局
Freeze of gait (FOG) Questionnaire
时间窗: 3 weeks
Consists of 16 items assessing freeze of gait. Total score ranges from 0 to 24, higher score corresponds to more severe FOG.
39-item Parkinson's Disease Questionnaire (PDQ-39)
时间窗: 3 weeks
This questionnaire assesses how often people affected by Parkinson's experience difficulties across 8 dimensions of daily living. It is scored on a scale of 0-100, with lower scores indicating better health and high scores more severe symptoms.
TIMED UP AND GO (TUG)
时间窗: 3 weeks
The TUG test is a physical performance measure in which the ability to rise up from a seated chair position, walk 3m, turn, walk back, and sit down is timed.
Unified Parkinson's disease rating scale
时间窗: 3 weeks
A comprehensive 50 question clinical rating scale for the assessment of both motor and non-motor symptoms associated with Parkinson's. The total cumulative score will range from 0 (no disability) to 199 (total disability).
Berg Balance Scale (BBS)
时间窗: 3 weeks
The BBS is a widely used clinical test of a person's static and dynamic balance abilities. t is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function.A score of 56 indicates functional balance.
Non-Motor Symptoms Scale (NMSS)
时间窗: 3 weeks
The non-motor symptoms questionnaire is a 30-point, patient-based questionnaire used to determine the non-motor symptoms experienced by the patient during the past month.Responses quantify symptoms according severity (using a scale of 0-3) and frequency (using a scale of 0-4). Higher scores represent more severe and more frequent symptoms.
次要结局
未报告次要终点