Instrumental Assessment of Motor Symptoms by Means of Wearable Sensors in Patients With Parkinson's Disease

Study Overview
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Brief Summary
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The clinical management of Parkinson's disease (PD) is frequently challenged by the occurrence of motor disorders and complications, such as freezing of gait, fluctuations and the ON-OFF phenomenon, primarily manifesting at home. Therapeutic decisions are usually based on periodic neurological examinations and patients' anamnestic experience collected in an outpatient setting, thus limited by several issues, including recall bias and subjective, semi-quantitative and operator-dependent evaluations in non-ecological settings. In the last two decades, new wearable technologies, consisting of wireless sensors (e.g., inertial, electromyography), have been widely applied to quantitatively assess movements in physiological and pathological conditions, even for prolonged periods in free-living settings (i.e., long-term monitoring). The aim of this study is to evaluate motor symptoms in patients with PD, such as bradykinesia, tremor, gait disturbances and balance disorders, objectively and quantitatively through the application of wearable sensors in intra- and extra hospital settings, also during common activities of daily living, in order to obtain ecological data possibly useful in the therapeutic management of the disease.

Official Title
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Instrumental Assessment of Motor Symptoms by Means of Wearable Sensors in Patients With Parkinson's Disease

Conditions
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Parkinson Disease, Motor Disorders

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of idiopathic Parkinson's disease according to current consensus criteria and confirmed by follow-up clinical evaluations; ability to walk independently Exclusion Criteria: dementia (MMSE < 24/30); comorbidities affecting gait (e.g., rheumatological or orthopedic issues); atypical parkinsonism.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy Subjects<br>Cohort of healthy subjects as control. | |
| Patients with Parkinson's disease<br>Cohort of patients with Parkinson's disease | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of OFF state of therapy during daily activity hours; | Time spent with poor motor control despite optimized pharmacological therapy | 24 hours | 
| Number of Wearing Off and ON-OFF phenomena | Number of motor complications despite optimized pharmacological therapy | 24 hours | 
| Number of freezing of gait episodes | Number of paroxysmal gait disorders despite optimized pharmacological therapy | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's disease, Wearable sensors