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RECRUITING
NCT06907589
NA

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

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

50 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2024-05-13

Completion Date

2026-01-08

Last Updated

2025-04-02

Healthy Volunteers

Yes

Interventions

DEVICE

Motor 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.

Locations (5)

Ospedale Santa Maria Annunziata AUSL Toscana Centro

Bagno a Ripoli, Firenze, Italy

Azienda Ospedaliero Universitaria Careggi

Florence, Italy

IRCCS Fondazione Don Carlo Gnocchi Firenze

Florence, Italy

Ospedale Apuane AUSL Toscana Nord Ovest

Massa, Italy

IRCCS Istituto Auxologico Italiano, Ospedale San Luca

Milan, Italy