NCT06907589Recruiting
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
Source: ClinicalTrials.gov · Last updated 2 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- First submitted
- 26 Mar 2025
- Start date
- 13 May 2024
- Primary completion date
- 31 Jan 2026
- Lead sponsor
- Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
- Diseases
- Parkinson disease
- NCT number
- NCT06907589
What you commit to
- Study type: Interventional
- Planned participants: 250
- From 13 May 2024 to the primary completion date, 31 Jan 2026
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Subjects with Parkinson's disease - Exclusion criteria:
- 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
Age
- Healthy subjects - Exclusion criteria:
- 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
Who the study is looking for
- 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
Age in the registry: 50 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ospedale Santa Maria Annunziata AUSL Toscana Centro Coordinator of this site? Confirm its status | Bagno a Ripoli | Italy | Recruiting |
| IRCCS Fondazione Don Carlo Gnocchi Firenze Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Careggi Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| Ospedale Apuane AUSL Toscana Nord Ovest Coordinator of this site? Confirm its status | Massa | Italy | Recruiting |
| IRCCS Istituto Auxologico Italiano, Ospedale San Luca Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.