Healthy Adult, Parkinson Disease
Conditions
Keywords
parkinson's disease, wearable sensors, motor data
Brief 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.
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.
Sponsors
Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy subjects - Inclusion Criteria: * 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 * expression of informed consent to participate in the study 2. Subjects with Parkinson's disease -- Inclusion criteria: * adult subjects, both sexes, 50-80 years of age * MMSE score \>= 24 * subjects with Parkinson's disease in the absence of motor fluctuations and dyskinesias, or subjects with Parkinson's disease with mild motor fluctuations throughout the day, but to be examined in the ON phase and in the absence of dyskinesias * Hoehn and Yahr stage 1, 2, 3 * 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 * expression of informed consent to participate in the study
Exclusion criteria
1. Healthy subjects -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of repetitions | at Enrollment (T0) | Number of repetitions in Finger 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 |
| Strides Number | at Enrollment (T0) | Number of strides to walk for 15 meters straight on |
Countries
Italy
Contacts
Primary ContactFilippo Cavallo
Backup ContactErika Rovini
Outcome results
None listed