Personal KinetiGraph® Clinical Validation Study

Study Overview
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Brief Summary
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The purpose of this study is to clinically validate new measures of the Personal KinetiGraph® (PKG®).

Detailed Description
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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.

Official Title
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Personal KinetiGraph® Clinical Validation Study

Conditions
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Movement Disorders, Parkinson Disease

Intervention / Treatment
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* Device: Personal KinetiGraph® (PKG®) System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Personal KinetiGraph® (PKG®) System|The PKG® System includes a wrist-worn device that records and measures movement patterns in conditions such as Parkinson's disease.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of new PKG assessments to be clinically validated for Gait/walking using movement data collected from the PKG Watch | 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. | 2-3 years | 
| Evaluation of new PKG assessments to be clinically validated for Device Assisted Therapy readiness using movement data collected from the PKG Watch | 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. | 2-3 years | 
| Evaluation of new PKG assessments to be clinically validated for Percent Time Bradykinesia using movement data collected from the PKG Watch (PTB) | 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). | 2-3 years | 
| Evaluation of new PKG assessments to be clinically validated for Percent Time Dyskinesia (PTD) using movement data collected from the PKG Watch | 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). | 2-3 years | 
| Evaluation of new PKG assessments to be clinically validated for fall prediction using movement data collected from the PKG Watch | 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. | 2-3 years | 
| Evaluation of new PKG assessments to be clinically validated for disease progression using movement data collected from the PKG Watch | 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. | 2-3 years | 
| Evaluation of new PKG assessments to be clinically validated for non-motor outcomes using non-motor scales | 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. | 2-3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of PKG scores to assess differences by age category | PKG measurements will be recorded and compared across age ranges (40-90 years old as defined in the Inclusion Criteria) for subjects enrolled. Age categories from 40-59 years old, 60-79 years old and 80-90 years old will be evaluated. | 2-3 years | 
| To compare PKG scores to standard Parkinson's disease assessments such as the Movement Disorder Specialist Unified Parkinson's Disease Scale | 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. | 2-3 years | 
| To compare PKG scores to standard Parkinson's disease assessments such as Parkinson's Disease Questionnaire (PDQ-39) | 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). | 2-3 years | 
| To compare PKG scores to standard Parkinson's disease assessments such as the Freezing of Gait Questionnaire (FOG-Q) | 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. | 2-3 years | 
| To compare PKG scores to standard Parkinson's disease assessments such as The Essential Tremor Rating Assessment Scale (TETRAS) | TETRAS assesses essential tremor severity and its impact on activities of daily living (ADL). The ADL section includes 12 items and the performance section includes 9. Each item is rated 0-4. Higher scores indicate more severe impacts of ADL and tremor. | 2-3 years | 
| To compare PKG scores to subject diaries | Subject diaries will include recordings of medication times, falls, symptoms and sleep. | 2-3 years | 
| To compare PKG scores to non-motor assessments such as the Non-Motor Symptoms Questionnaire (NMSQ) | The NMSQ includes 30 questions, answered either yes or no, and assesses the presence, not severity, of non-motor symptoms. | 2-3 years | 
| To compare PKG scores to sleep assessments such as Epworth Sleepiness Scale (ESS) and Parkinson's Disease Sleep Scale (PDSS) | The ESS includes 8 questions each scored from 0-3 with a maximum score of 24. The higher the ESS score, the higher that person's average sleep propensity or 'daytime sleepiness'. The PDSS includes 15 questions, each rated from 0 to 10, with 0 being Awful or Always and 10 being Excellent or Never. | 2-3 years | 
| To compare PKG scores to the Montreal Cognitive Assessment (MoCA) | The MoCA is an assessment used for detecting cognitive impairment. The scores range from 0 to 30 with 0 being the lowest and 30 being the highest. | 2-3 years | 
| To compare PKG scores to quality of life measurements such as EuroQual 5-D (EQ-5D) | The EQ-5D assesses health-related quality of life. Each question is scored from either 1-3 or 1-5, with 1 indicating no problems and 3 or 5 indicating extreme problems. | 2-3 years | 
| To evaluate product usability and satisfaction for PKG Watch, docking station and PKG Portal | PKG product usability and satisfaction questionnaires will be used to evaluate this outcome. Responses to questions range from very difficult to very easy, strongly disagree to strongly agree, very uncomfortable to very comfortable. | 2-3 years |