Personal KinetiGraph® Clinical Validation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Evaluation of new PKG assessments to be clinically validated for Percent Time Bradykinesia using movement data collected from the PKG Watch (PTB)
研究概览
简要总结
The purpose of this study is to clinically validate new measures of the Personal KinetiGraph® (PKG®).
详细描述
This is a prospective, observational research study of the Personal KinetiGraph (PKG) System. The PKG System is intended to quantify kinematics of movement disorder symptoms in conditions such as Parkinson's disease, including tremor, bradykinesia and dyskinesia. This study aims to clinically validate new PKG assessments such as walking, Device Assisted Therapy readiness, Percent Time Bradykinesia, Percent Time Dyskinesia, fall prediction, disease progression and non-motor. The clinical validation will require enrollment of both subjects with a diagnosis of movement disorder, such as Parkinson's disease, and healthy control subjects who do not a neurological disorder.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able and willing to sign a written informed consent for study participation
- •Existing diagnosis of a movement disorder or a healthy control subject without diagnosis of a movement disorder
排除标准
- •Bedridden, wheelchair confined, or requires the regular use of an assistive gait device (e.g., walker, cane, etc.)
- •Occupation that involves repetitive movement or complete immobility (e.g., janitor, construction, or sedentary with no/limited arm movements such as a taxi driver)
- •In the investigator's or sponsor's opinion, subject has any unstable or clinically significant condition that would impair the participant's ability to complete the required PKG watch wear (e.g., subject unable to complete PKG wear instructions per Patient Instruction Manual), complete required assessments or interfere with data collection.
结局指标
主要结局
Evaluation of new PKG assessments to be clinically validated for Percent Time Bradykinesia using movement data collected from the PKG Watch (PTB)
时间窗: 2-3 years
Data collected from the PKG system may be compared to scores from the Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and the Parkinson's Disease Questionnaire (PDQ-39). The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson's and consists of 4 parts. Parts I and II each contain 13 questions, Part III contains 33 and Part IV contains 6. Each score ranges from 0 (normal) to 4 (severe). Higher scores indicate a greater impact of Parkinson's disease symptoms. The PDQ-39 includes 39 questions that assess Parkinson's disease health related quality of life. Each dimension total score range from 0 (never have difficulty) to 100 (always have difficulty).
Evaluation of new PKG assessments to be clinically validated for fall prediction using movement data collected from the PKG Watch
时间窗: 2-3 years
PKG measurements may be compared to data collected from freezing of gait questionnaire (FOG-Q) and posture analysis. The FOG-Q assesses freezing of gait severity and consists of 4 questions, each scored from 0-4. Higher scores indicates more severe freezing of gait. Step count performance may also be used to evaluate fall prediction. The PKG's step detection system and manual step counts may be compared between healthy controls and person's with Parkinson's disease, while their walking is video recorded.
Evaluation of new PKG assessments to be clinically validated for disease progression using movement data collected from the PKG Watch
时间窗: 2-3 years
Disease progression may be evaluated by predicting the levodopa response using severity levels of the Bradykinesia Score (BKS) and early morning Bradykinesia. Changes in PKG measurements may be compared to the MDS-UPDRS which evaluates motor and non-motor symptoms in persons with Parkinson's and consists of 4 parts. Parts I and II each contain 13 questions, Part III contains 33 and Part IV contains 6. Each score ranges from 0 (normal) to 4 (severe). Higher scores indicate a greater impact of Parkinson's disease symptoms.
Evaluation of new PKG assessments to be clinically validated for non-motor outcomes using non-motor scales
时间窗: 2-3 years
PKG system data may be compared to non-motor assessments such as the non-motor questionnaire (NMSQ). The NMSQ includes questions regarding non-motor symptoms such as difficulty swallowing, constipation, difficulty sleeping, cognition, mood. Higher scores indicate more non-motor symptoms.
Evaluation of new PKG assessments to be clinically validated for Percent Time Dyskinesia (PTD) using movement data collected from the PKG Watch
时间窗: 2-3 years
Data collected from the PKG system may be compared to scores from the Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and the Parkinson's Disease Questionnaire (PDQ-39). The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson's and consists of 4 parts. Parts I and II each contain 13 questions, Part III contains 33 and Part IV contains 6. Each score ranges from 0 (normal) to 4 (severe). Higher scores indicate a greater impact of Parkinson's disease symptoms. The PDQ-39 includes 39 questions that assess Parkinson's disease health related quality of life. Each dimension total score range from 0 (never have difficulty) to 100 (always have difficulty).
Evaluation of new PKG assessments to be clinically validated for Gait/walking using movement data collected from the PKG Watch
时间窗: 2-3 years
The PKG's step detection system and manual step counts may be compared between healthy controls and person's with Parkinson's disease, while their walking is video recorded.
Evaluation of new PKG assessments to be clinically validated for Device Assisted Therapy readiness using movement data collected from the PKG Watch
时间窗: 2-3 years
For this outcome, patients may be classified as Device Assisted Therapy (DAT) criteria positive or criteria negative. DAT readiness may be evaluated using the Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS). The MDS-UPDRS evaluates motor and non-motor symptoms in persons with Parkinson's and consists of 4 parts. Parts I and II each contain 13 questions, Part III contains 33 and Part IV contains 6. Each score ranges from 0 (normal) to 4 (severe). Higher scores indicate a greater impact of Parkinson's disease symptoms. PKG measurements may be compared to the patient's clinical characteristics and MDS-UPDRS scores.
次要结局
- To compare PKG scores to subject diaries(2-3 years)
- To compare PKG scores to quality of life measurements such as EuroQual 5-D (EQ-5D)(2-3 years)
- Evaluation of PKG scores to assess differences by age category(2-3 years)
- To evaluate product usability and satisfaction for PKG Watch, docking station and PKG Portal(2-3 years)
- To compare PKG scores to sleep assessments such as Epworth Sleepiness Scale (ESS) and Parkinson's Disease Sleep Scale (PDSS)(2-3 years)
- To compare PKG scores to standard Parkinson's disease assessments such as the Movement Disorder Specialist Unified Parkinson's Disease Scale(2-3 years)
- To compare PKG scores to non-motor assessments such as the Non-Motor Symptoms Questionnaire (NMSQ)(2-3 years)
- To compare PKG scores to the Montreal Cognitive Assessment (MoCA)(2-3 years)
- To compare PKG scores to standard Parkinson's disease assessments such as Parkinson's Disease Questionnaire (PDQ-39)(2-3 years)
- To compare PKG scores to standard Parkinson's disease assessments such as the Freezing of Gait Questionnaire (FOG-Q)(2-3 years)
- To compare PKG scores to standard Parkinson's disease assessments such as The Essential Tremor Rating Assessment Scale (TETRAS)(2-3 years)