NCT05462080已完成不适用
Correlation of Motor Metrics and Neurological Data (COMMAND)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Collection of data with Ceraxis product (stylus product with a built-in Inertial Measurement Unit (IMU) which includes a 3-axis accelerometer, gyroscope, and magnetometer, as well as a force sensing tip)
研究概览
简要总结
This is a pilot study to collect data with the Ceraxis product and standard movement disorders tests in order to prove and codify potential correlations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult with a diagnosis of idiopathic Parkinson's disease or essential tremor by a movement disorders neurologist
- •Age greater than or equal to 21 years
- •Hoehn and Yahr stage I-III
- •Ability to ambulate 200+ meters independently
- •Ability to follow 2-step commands
- •Clinically responsive to medication or Deep Brain Stimulation (DBS)
- •Clinically optimized medication or DBS for at least six months
- •Able to tolerate withdrawal of medication and/or DBS
排除标准
- •Any comorbidity which would exclude them from being able to use the Ceraxis product
- •Inability to learn how to use the system
- •Diagnosis of dementia or impairment that compromises the ability to provide informed consent
- •Neurological disease other than Parkinson's disease or essential tremor (i.e. multiple sclerosis, stroke with residual motor deficits)
- •Musculoskeletal injury that significantly alters gait
结局指标
主要结局
Collection of data with Ceraxis product (stylus product with a built-in Inertial Measurement Unit (IMU) which includes a 3-axis accelerometer, gyroscope, and magnetometer, as well as a force sensing tip)
时间窗: Day 1
Patients will be guided through a set of actions while the sensors record movement data on their upper and lower extremity motor symptoms. This data will be correlated with the secondary outcome measures post hoc.
次要结局
- Archimedes Spiral task(Day 1)
- UPDRS-I, UPDRS-II, and UPDRS-III assessment for patients with Parkinson's disease(Day 1)
- TETRAS tremor rating scale for patients with Essential Tremor(Day 1)
- Upper extremities motor strength, assessed by neurological examination(Day 1)
- Freezing of Gait questionnaire(Day 1)
- Coordination test for the upper extremities to evaluate dysdiadochokinesia(Day 1)
- Usage Survey(Day 1)
研究者
研究点 (1)
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