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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
250
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.
Ospedale Santa Maria Annunziata AUSL Toscana Centro
Bagno a Ripoli, Firenze, Italy
RECRUITINGAzienda Ospedaliero Universitaria Careggi
Florence, Italy
RECRUITINGIRCCS Fondazione Don Carlo Gnocchi Firenze
Florence, Italy
RECRUITINGOspedale Apuane AUSL Toscana Nord Ovest
Massa, Italy
RECRUITINGIRCCS Istituto Auxologico Italiano, Ospedale San Luca
Milan, Italy
RECRUITINGNumber of repetitions
Number of repetitions in Finger Tapping task
Time frame: at Enrollment (T0)
Number of repetitions
Number of repetitions in Thumb-ForeFinger Tapping task
Time frame: at Enrollment (T0)
Number of repetitions
Number of repetitions in Opening/Closing task
Time frame: at Enrollment (T0)
Number of repetitions
Number of repetitions in Pronosupination task
Time frame: at Enrollment (T0)
Number of repetitions
Number of repetitions in Toe Tapping task
Time frame: at Enrollment (T0)
Number of repetitions
Number of repetitions in Leg Agility task
Time frame: at Enrollment (T0)
Number of repetitions
Number of repetitions in Heel Tapping task
Time frame: at Enrollment (T0)
Number of repetitions
Number of repetitions in Heel-Toe Tapping task
Time frame: at Enrollment (T0)
Time to Stand Up
Time to stand up from a chair
Time frame: at Enrollment (T0)
Gait Time
Time to walk for 15 meters straight on
Time frame: at Enrollment (T0)
Rotation Time
Time to perform a turning of 360°
Time frame: at Enrollment (T0)
Fundamental frequency of accelerometer signal
Fundamental frequency of accelerometer signal for hands resting tremor task
Time frame: At enrollment (T0)
Fundamental frequency of accelerometer signal
Fundamental frequency of accelerometer signal for feet resting tremor task
Time frame: At enrollment (T0)
Fundamental frequency of accelerometer signal
Fundamental frequency of accelerometer signal for hands postural tremor task
Time frame: At enrollment (T0)
Fundamental frequency of accelerometer signal
Fundamental frequency of accelerometer signal for hands kinetic tremor task
Time frame: At enrollment (T0)
Strides Number
Number of strides to walk for 15 meters straight on
Time frame: at Enrollment (T0)
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