RecruitingNot ApplicableNCT06907589

A Novel Accessible and Widespread Healthcare Service Model Based on Technology Innovation for Objective (Early) Diagnosis and Therapeutic Monitoring of Parkinson's Disease Promoting Continuity of Care

Sponsor

Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna

Enrollment

250 participants

Start Date

May 13, 2024

Study Type

INTERVENTIONAL

Conditions

Parkinson Disease Healthy Adult

Summary

The present study aims to use the SensMode System - a system composed of wearable devices for upper and lower limb movement analysis and electronic device for data acquisition and processing - on healthy subjects, subjects with idiopathic hyposmia, patients with Parkinson's disease, and subjects with de-novo drug-naïve extrapyramidal syndrome. The purpose is to identify normative data of objective motor measures obtained with such a system, as well as to increase knowledge about the potential contribution such a solution can make to the preclinical diagnosis of Parkinson's disease and the management of patients with this disease.

Eligibility

Min Age: 50 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is developing and testing a technology-based healthcare service — using digital tools and sensors — to help detect Parkinson's disease earlier and monitor how patients respond to treatment over time. **You may be eligible if...** - You are between 50 and 80 years old - You either have no neurological conditions (healthy volunteer group) or have a confirmed Parkinson's disease diagnosis - You are able to walk and move without significant physical limitations from injury - You have adequate mental function (MMSE score of 24 or higher) **You may NOT be eligible if...** - You have smell-related deficits (for healthy volunteers) - You have movement limitations from injury or other causes - You are outside the 50–80 age range Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMotor Data Analysis

The SensMode System includes wearable devices for upper and lower limb motion analysis. The upper limb device, SensHand, consists of 3 sensorized elements: 2 sensorized rings to be placed at the level of the distal phalanx of the thumb and forefinger of the hand and 1 sensorized wristband to be placed at the level of the distal portion of the forearm near the wrist. Each element of SensHand allows the acquisition of inertial data with respect to the biomechanics of the arm-forearm-wrist and the first three fingers of the hand, measuring the 3 components in space of linear acceleration, angular velocity, and magnetic field. The lower limb device, SensFoot, is a device that integrates the same electronic components as the bracelet and is placed in a plastic housing shaped like a small rectangular parallelepiped that is placed over the shoe.