Recruiting · registry statusUsing wearable sensors to support Parkinson’s care
Researchers investigate movement sensors worn on the arms and legs as tools for assessment, diagnosis and monitoring treatment.
Testing a treatment or activity · Study reference: NCT06907589
Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓
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Looking for volunteers
- Start (reported actual date)
- 2024-05-13
- Main measurements finished (planned)
- 2026-01
- Study finished (planned)
- 2026-01-08
Planned dates can move. A study finishing does not tell us when a paper will be published.
No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.
Changes we have recorded
These are dates we observed a change, not necessarily the dates it happened.
Papers connected to this study
No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.
Who can join?
Ages 50 years to 80 years · Also accepts healthy volunteers
These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.
Read all the rules for taking part
Sex eligibility reported by registry: all
Inclusion Criteria:
1. 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
2. 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
Exclusion Criteria:
1. 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
2. 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
Full study name & original research details
Official study 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
Original description
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 reported: Parkinson Disease; Healthy Adult
Registry records for this study
Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.
- Study type
- Interventional
- Interventions
- Motor Data Analysis
- Phases
- NA
- Sponsor
- Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
- Start date reported by registry
- 2024-05-13 (actual)
Registry updated: 2025-04-02 · Status last verified by the registry submitter: 2025-03
Registry records retrieved 2026-10-13 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.
Contact the research team
Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.
Filippo Cavallo · +390552758663 · filippo.cavallo@santannapisa.it
Erika Rovini · +390553758663 · erika.rovini@unifi.it
Study locations
Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.
Ospedale Santa Maria Annunziata AUSL Toscana Centro
Bagno a Ripoli, Firenze, Italy
RecruitingPaola Vanni · +390552313862 · paola.vanni@uslcentro.toscana.it
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
RecruitingSilvia Ramat · +390557947956 · silvia.ramat@unifi.it
IRCCS Fondazione Don Carlo Gnocchi Firenze
Florence, Italy
RecruitingGemma Lombardi · +3905557393917 · glombardi@dongnocchi.it
Ospedale Apuane AUSL Toscana Nord Ovest
Massa, Italy
RecruitingCarlo Maremmani · +3905854931 · carlo.maremmani@uslnordovest.toscana.it
IRCCS Istituto Auxologico Italiano, Ospedale San Luca
Milan, Italy
RecruitingAndrea Ciammola · +39026191129 · a.ciammola@auxologico.it
Facility not reported
Italy
Status not reportedThe original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.