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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 80
Healthy Volunteers: t
View:

• 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

• 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

Locations
Other Locations
Italy
Ospedale Santa Maria Annunziata AUSL Toscana Centro
RECRUITING
Bagno A Ripoli
Azienda Ospedaliero Universitaria Careggi
RECRUITING
Florence
IRCCS Fondazione Don Carlo Gnocchi Firenze
RECRUITING
Florence
Ospedale Apuane AUSL Toscana Nord Ovest
RECRUITING
Massa
IRCCS Istituto Auxologico Italiano, Ospedale San Luca
RECRUITING
Milan
Contact Information
Primary
Filippo Cavallo
filippo.cavallo@santannapisa.it
+390552758663
Backup
Erika Rovini
erika.rovini@unifi.it
+390553758663
Time Frame
Start Date: 2024-05-13
Estimated Completion Date: 2026-01-08
Participants
Target number of participants: 250
Treatments
Experimental: Motor Data Analysis for Healthy Subjects
All subjects who are recruited in the study undergo sensors administration for motor analysis at the enrollement
Experimental: Motor Data Analysis for patients with Parkinson's disease
All subjects who are recruited in the study undergo sensors administration for motor analysis at the enrollement
Related Therapeutic Areas
Sponsors
Leads: Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna

This content was sourced from clinicaltrials.gov