Free-living Monitoring of Parkinson's Disease Using Smart Objects

Study Overview
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Brief Summary
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Parkinson's disease, one of the most common neurodegenerative diseases of the central nervous system, presents motor symptoms, including tremor, rigidity, bradykinesia, and postural instability. Assessments of patients with Parkinson's disease are typically performed using clinical scales, compiled by the healthcare staff or by the patient. Although commonly used in clinical practice, they have some limitations, including the low temporal resolution of the scales, the low granularity of the scores and the possible low inter- and intra-operator reliability. The recent development of digital technologies has led to the creation of IoT (Internet of Things) devices capable of providing quantitative indicators, potentially useful for an accurate differential diagnosis, as well as for monitoring the effects of therapeutic interventions. The peculiarity of these systems is the ability to provide indicators not only during periodic visits to the clinic, but also the ability to remotely monitor the patient's daily life activities. In this scenario, this study wants to test the hypothesis that the IoT devices like smart-ink pens and insoles are usable options for monitoring patients with Parkinson's disease.

Official Title
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Free-living Monitoring of Parkinson's Disease Using Smart Objects: Towards Digital Medicine

Conditions
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Parkinson Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult individuls Cognitive impairments Ability to independently sign the written informed consent Exclusion Criteria: Unstable pharmacological treatment for Parkinson's Disease during the study Previous history of major neurological, vascular, musculoskeletal disorders

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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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| System Usability Scale | Score ranges from 0 (no usability) to 100 (excellent usability) | 1-2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Movement Disordered Society - Unified Parkinson's Disease Rating Scale | Parkinson's Disease prognosis information. Score ranges from 0 (normal) to 199 (severe impairment). | Baseline | 
| Execution handwriting time | Time required to complete the handwriting task measured by the smart ink pen, in seconds | Baseline | 
| Execution handwriting time | Time required to complete the handwriting task measured by the smart ink pen, in seconds | 1-2 weeks | 
| Average handwriting force | The average exerted force during handwriting task measured by the smart ink pen, in arbitrary units | Baseline | 
| Average handwriting force | The average exerted force during handwriting task measured by the smart ink pen, in arbitrary units | 1-2 weeks | 
| Gait speed | Gait speed [cm/s] measured by sensorized insoles | Baseline | 
| Gait speed | Gait speed [cm/s] measured by sensorized insoles | 1-2 weeks |