Actively Recruiting
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
Led by Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna · Updated on 2025-04-02
250
Participants Needed
5
Research Sites
86 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 50 to 80 years, both sexes
- MMSE score of 24 or higher
- No olfactory deficit based on IOIT olfactory test (age-specific scores for normal)
- No neurological diseases (for healthy subjects)
- No functional locomotion deficits due to injury or other causes affecting limbs, pelvis, or spine
- Diagnosis of Parkinson's disease with Hoehn and Yahr stage 1, 2, or 3 (for Parkinson's patients)
- Parkinson's patients with no motor fluctuations or mild fluctuations examined in ON phase without dyskinesias
- Ability to provide informed consent
You will not qualify if you...
- Refusal to give informed consent
- Presence of olfactory deficit based on IOIT olfactory test (age-specific scores for hyposmia)
- Body weight over 120 kg
- Insufficient cooperation
- Active malignant neoplasm or cancer with less than 6 years follow-up
- Joint stiffness preventing proper movement of upper or lower limbs
- Muscle weakness or paralysis from nerve injury
- Sensory or motor neuropathy
- Chronic inflammatory joint diseases
- Acute vertigo
- Neurodegenerative diseases other than Parkinson's
- Fever
- Venous thrombosis
- Cardiovascular or other acute/chronic conditions affecting motor exercise
- Spinal or joint pain affecting motor exercises
- History of recurrent acute neck or lower back pain
- Hoehn and Yahr stage 4 or 5 (for Parkinson's patients)
- Need for walking aid or assistance (for Parkinson's patients)
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Ospedale Santa Maria Annunziata AUSL Toscana Centro
Bagno a Ripoli, Firenze, Italy, 50012
Actively Recruiting
2
Azienda Ospedaliero Universitaria Careggi
Florence, Italy, 50134
Actively Recruiting
3
IRCCS Fondazione Don Carlo Gnocchi Firenze
Florence, Italy, 50143
Actively Recruiting
4
Ospedale Apuane AUSL Toscana Nord Ovest
Massa, Italy, 54100
Actively Recruiting
5
IRCCS Istituto Auxologico Italiano, Ospedale San Luca
Milan, Italy, 20149
Actively Recruiting
Research Team
F
Filippo Cavallo
CONTACT
E
Erika Rovini
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
2
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