RecruitingNot ApplicableNCT06907589

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

Enrollment

250 participants

Start Date

May 13, 2024

Study Type

INTERVENTIONAL

Conditions

Parkinson Disease Healthy Adult

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

Min Age: 50 YearsMax Age: 80 Years

Inclusion Criteria11

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
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 Criteria32

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
malignant neoplasm in progress or with negative follow-up of less than 6 years
structured joint stiffness in the upper and/or lower extremities preventing proper execution of movements
paresis and/or plegia of upper and/or lower limb muscle groups from both peripheral and central nerve injury
mono/multi/poly sensory and/or motor neuropathy
chronic inflammatory diseases with joint involvement of the upper and/or lower limbs
vertiginous syndromes in the acute phase
neurodegenerative diseases
fever
venous thrombosis
cardiovascular disorders or other acute or chronic conditions capable of affecting the proper performance of motor exercises
spinal or joint pain of various etiologies that may affect the performance of motor exercises
positive history of recurrent acute cervico-brachialgia and/or lumbosciatica
Denial of informed consent to participate in the study
Hoenn and Yahr stage 4, 5
Patient who needs to use an aid (cane or walker) while walking or cannot walk unless aided by a person
body weight greater than 120 kg
insufficient degree of cooperation
malignant neoplasm in place or with negative follow-up of less than 6 years
structured joint stiffness in the upper and/or lower extremities that prevents proper execution of movements
paresis and/or plegia of upper and/or lower limb muscle groups from both peripheral and central nerve injury mono/multi/poly sensory and/or motor neuropathy
chronic inflammatory diseases with joint involvement of the upper and/or lower limbs
vertiginous syndromes in the acute phase
neurodegenerative diseases, excluding Parkinson's disease
fever
venous thrombosis
cardiovascular disorders or other acute or chronic conditions capable of affecting the proper performance of motor exercises
spinal or joint pain of various etiologies that may affect the performance of motor exercises
positive history of recurrent acute cervico-brachialgia and/or low back pain

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.