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
1 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the SensMode System, a set of wearable devices designed to analyze upper and lower limb movements. This study involves healthy adults, subjects with idiopathic hyposmia, patients with Parkinson's disease, and individuals with newly diagnosed drug-nafve extrapyramidal syndrome. The goal is to establish normal ranges for objective motor measurements and explore how this technology might aid in early diagnosis and management of Parkinson's disease. Participants will use the SensMode System, which includes SensHand and SensFoot devices. SensHand consists of sensorized rings and a wristband that measure movement and orientation of the hand and forearm, while SensFoot is a device placed over the shoe to assess lower limb motion. All subjects undergo motor analysis using these sensors at enrollment. During the study, researchers will monitor various motor outcome measures such as the number of repetitions of specific movements, time to stand up, gait time, rotation time, fundamental frequencies from accelerometer signals, and stride count at enrollment. This data will help characterize motor function and support further research into Parkinson's disease diagnosis and care. The study runs from May 2024 to January 2026 and includes adults aged 50 to 80 years.
CONDITIONS
Brief 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...
- Adult subjects, both sexes, aged 50-80 years old
- MMSE score of 24 or higher
- For healthy subjects: no olfactory deficit as measured by IOIT olfactory test with age-specific normal scores
- No neurological diseases
- No functional deficits in locomotion due to injury or other causes affecting limbs, pelvis, or spine
- Informed consent to participate in the study
- For Parkinson's disease subjects: diagnosis of Parkinson's disease without severe motor fluctuations or dyskinesias
- Hoehn and Yahr stage 1, 2, or 3
- Examined in the ON phase and absence of dyskinesias
- Informed consent to participate in the study
You will not qualify if you...
- Denial of informed consent
- Olfactory deficit detected on IOIT olfactory test above age-specific hyposmia thresholds for healthy subjects
- Body weight greater than 120 kg
- Insufficient cooperation
- Active malignant neoplasm or negative follow-up less than 6 years
- Structured joint stiffness preventing movement execution
- Paresis or plegia of upper or lower limbs from nerve injury
- Sensory and/or motor neuropathy
- Chronic inflammatory joint diseases
- Acute vertiginous syndromes
- Neurodegenerative diseases other than Parkinson's disease
- Fever
- Venous thrombosis
- Cardiovascular or other acute or chronic conditions affecting motor exercise performance
- Spinal or joint pain affecting motor exercises
- History of recurrent acute cervico-brachialgia or low back pain
- For Parkinson's disease subjects: Hoehn and Yahr stage 4 or 5
- Need for walking aid or inability to walk without assistance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo sensor administration for motor analysis using wearable devices to measure upper and lower limb motion.
1 baseline visit (in-person)
Duration - Up to study completion in January 2026
Participants are observed for motor function through wearable device data collection to assess Parkinson's disease symptoms and motor performance.
Ongoing data collection without additional visits
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
E
Erika Rovini
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here