NCT05120609Unknown不适用
A Randomized, Cross-Over, Placebo-Controlled Pilot Study to Evaluate the Self-Management of Gait, Speech and Dexterity in Patients With Parkinson's Disease Using a Novel Digital Therapeutic Approach
Beats Medical2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in Gait Velocity (m/s)
研究概览
简要总结
The purpose of this study is to evaluate the impact of a smartphone application that delivers at-home therapy exercises on patients' self-management of gait, speech, and dexterity symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Male and female subjects at least 30 years of age or older,
- •History of idiopathic Parkinson's Disease (Hoehn and Yahr stage of II-IV),
- •Normal joint range of motion in both legs,
- •Able to walk independently for 10 feet with or without an assistive device,
- •Parkinson's gait and mild to moderate speech impairment,
- •No history of vestibular disease,
- •No evidence of dementia (MMSE ≥24),
- •Clear benefit from Levodopa,
- •Agrees to Beats Medical Application Privacy Policy and Terms of Use,
- •Access to an iPhone 7 or higher to use the Beats Medical applications.
排除标准
- •Medical condition for which exercise is contraindicated,
- •History or evidence of neurological deficit other than Parkinson's Disease that could interfere, such as previous stroke or muscle disease,
- •History or evidence of orthopaedic or muscular problems,
- •Subject is currently enrolled in a study to evaluate an investigational drug or device,
- •Subject unable or unwilling to provide informed consent,
- •Vulnerable populations as deemed inappropriate for the study by site Principal Investigator,
- •History of falls in the past 6 months,
- •Pregnancy,
- •Current or previous use of the Beats Medical Parkinson's application.
结局指标
主要结局
Change in Gait Velocity (m/s)
时间窗: Baseline, Week 4, Week 8, Week 12
Gait velocity on a 10-Meter Walk Test (10MWT) conducted in-clinic.
次要结局
- Step Length (m)(Baseline, Week 4, Week 8, Week 12)
- MDS-UPDRS Total Score for Part II Item 2.1 + Part III Item 3.1(Baseline, Week 4, Week 8, Week 12)
- Step Frequency (steps/min)(Baseline, Week 4, Week 8, Week 12)
- MDS-UPDRS Part II Total Score(Baseline, Week 4, Week 8, Week 12)
- MDS-UPDRS Total Score for Part II Item 2.7 + Part III Item 3.4 + Part III 3.5(Baseline, Week 4, Week 8, Week 12)
- Daily steps(Week 1,2,3,4,5,6,7,8)
研究者
研究点 (2)
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