About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Adult subjects, both sexes, aged 50-80 years old
MMSE score >= 24 absence of olfactory deficit detected on IOIT olfactory test (22). Age class 50-59 years: normal with score <=5; age class 60-69 years: normal with score <=6; age class > 70 years: normal with score <=7
absence of neurological diseases
absence of functional deficit in the sphere of locomotion as a result of traumatic injury or from other cause to the upper and/or lower limbs and/or pelvis and/or spine
Disqualifiers
denial of informed consent to participate in the study
Presence of olfactory deficit detected on IOIT olfactory test. Age class 50-59 years: hyposmia with score >=6; age class 60-69 years: hyposmia with score >=7; age class > 70 years: hyposmia with score >=8
body weight greater than 120 kg
insufficient degree of cooperation
Trial design
Single group
Treatments tested in this trial
Motor Data Analysis
DeviceThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Number of repetitions
Number of repetitions in Finger Tapping task
Number of repetitions
Number of repetitions in Thumb-ForeFinger Tapping task
Number of repetitions
Number of repetitions in Opening/Closing task
Number of repetitions
Number of repetitions in Pronosupination task
Sponsors and contacts
Click on the lead sponsor to view all of their trials.