Wearable Sensors to Measure Movement in Parkinson's Disease
Tests wearable motion sensors for early detection and monitoring of Parkinson's disease in adults.
Key facts
- Who runs it
- Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
- Where
- Bagno a Ripoli, Florence, Massa, and Milan, ItalySee the 5 sites
- Trial code
- Registry 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
- Status
- Recruiting
- People taking part
- 250 people, planned
- Started
- 13 May 2024
- Planned end
- 8 Jan 2026
- Type of study
- Interventional, 2 groups
- Treatments tested
- Motor Data Analysis
- Record updated
- 2 April 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for healthy adults and adults with Parkinson's disease. It tests a wearable system that measures arm and leg movement.
- Age
- 50 to 80 years
- Sex
- Men and women
- Disease stage
- People with Parkinson's disease: Hoehn and Yahr stage 1, 2 or 3. Without motor fluctuations or dyskinesias, or with mild motor fluctuations tested in the ON phase without dyskinesias.
- Biomarker or test result
- MMSE score of 24 or more. Healthy people must also have a normal sense of smell on the IOIT olfactory test.
Main reasons for not taking part
- Body weight over 120 kg (265 lb)
- Parkinson's disease at Hoehn and Yahr stage 4 or 5
- Needs a cane or walker, or cannot walk without help from a person
- Cancer in progress or less than 6 years of negative follow-up
- Other neurodegenerative diseases, or conditions affecting the arms, legs or spine that disturb the movement exercises
The registry criteria, word for word
Show all 4 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 50 and 80 years old?
Where in Italy
- Ospedale Santa Maria Annunziata AUSL Toscana CentroBagno a Ripoli, ItalyContact: Paola VanniTaking people
- Azienda Ospedaliero-Universitaria CareggiFlorence, ItalyContact: Silvia RamatTaking people
- IRCCS Fondazione Don Carlo Gnocchi FirenzeFlorence, ItalyContact: Gemma LombardiTaking people
- Ospedale Apuane AUSL Toscana Nord OvestMassa, ItalyContact: Carlo MaremmaniTaking people
- IRCCS Istituto Auxologico Italiano, Ospedale San LucaMilan, ItalyContact: Andrea CiammolaTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Motor Data Analysis for Healthy SubjectsTreatment being tested
All subjects who are recruited in the study undergo sensors administration for motor analysis at the enrollement
Treatment: Motor Data Analysis
- Motor Data Analysis for patients with Parkinson's diseaseTreatment being tested
All subjects who are recruited in the study undergo sensors administration for motor analysis at the enrollement
Treatment: Motor Data Analysis
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- Wearable Sensors to Measure Movement in Parkinson's DiseaseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06907589, who can take part
- Record updated
- 2 April 2025