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
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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
Primary outcome measure(s)
- Number of repetitions — at Enrollment (T0)
Number of repetitions in Finger Tapping task - Number of repetitions — at Enrollment (T0)
Number of repetitions in Thumb-ForeFinger Tapping task - Number of repetitions — at Enrollment (T0)
Number of repetitions in Opening/Closing task - Number of repetitions — at Enrollment (T0)
Number of repetitions in Pronosupination task - Number of repetitions — at Enrollment (T0)
Number of repetitions in Toe Tapping task - Number of repetitions — at Enrollment (T0)
Number of repetitions in Leg Agility task - Number of repetitions — at Enrollment (T0)
Number of repetitions in Heel Tapping task - Number of repetitions — at Enrollment (T0)
Number of repetitions in Heel-Toe Tapping task - Time to Stand Up — at Enrollment (T0)
Time to stand up from a chair - Gait Time — at Enrollment (T0)
Time to walk for 15 meters straight on - Rotation Time — at Enrollment (T0)
Time to perform a turning of 360° - Fundamental frequency of accelerometer signal — At enrollment (T0)
Fundamental frequency of accelerometer signal for hands resting tremor task - Fundamental frequency of accelerometer signal — At enrollment (T0)
Fundamental frequency of accelerometer signal for feet resting tremor task - Fundamental frequency of accelerometer signal — At enrollment (T0)
Fundamental frequency of accelerometer signal for hands postural tremor task - Fundamental frequency of accelerometer signal — At enrollment (T0)
Fundamental frequency of accelerometer signal for hands kinetic tremor task - Strides Number — at Enrollment (T0)
Number of strides to walk for 15 meters straight on
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| Ospedale Santa Maria Annunziata AUSL Toscana Centro | Bagno a Ripoli | Firenze | Recruiting |
| Azienda Ospedaliero Universitaria Careggi | Florence | Italy | Recruiting |
| IRCCS Fondazione Don Carlo Gnocchi Firenze | Florence | Italy | Recruiting |
| Ospedale Apuane AUSL Toscana Nord Ovest | Massa | Italy | Recruiting |
| IRCCS Istituto Auxologico Italiano, Ospedale San Luca | Milan | Italy | Recruiting |
More Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06907589 on ClinicalTrials.gov ↗ ← All trials in Italy