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
NCT ID: NCT06907589
Last Updated: 2025-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
250 participants
INTERVENTIONAL
2024-05-13
2026-01-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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Motor Data Analysis for Healthy Subjects
All subjects who are recruited in the study undergo sensors administration for motor analysis at the enrollement
Motor Data Analysis
The SensMode System includes wearable devices for upper and lower limb motion analysis. The upper limb device, SensHand, consists of 3 sensorized elements: 2 sensorized rings to be placed at the level of the distal phalanx of the thumb and forefinger of the hand and 1 sensorized wristband to be placed at the level of the distal portion of the forearm near the wrist. Each element of SensHand allows the acquisition of inertial data with respect to the biomechanics of the arm-forearm-wrist and the first three fingers of the hand, measuring the 3 components in space of linear acceleration, angular velocity, and magnetic field. The lower limb device, SensFoot, is a device that integrates the same electronic components as the bracelet and is placed in a plastic housing shaped like a small rectangular parallelepiped that is placed over the shoe.
Motor Data Analysis for patients with Parkinson's disease
All subjects who are recruited in the study undergo sensors administration for motor analysis at the enrollement
Motor Data Analysis
The SensMode System includes wearable devices for upper and lower limb motion analysis. The upper limb device, SensHand, consists of 3 sensorized elements: 2 sensorized rings to be placed at the level of the distal phalanx of the thumb and forefinger of the hand and 1 sensorized wristband to be placed at the level of the distal portion of the forearm near the wrist. Each element of SensHand allows the acquisition of inertial data with respect to the biomechanics of the arm-forearm-wrist and the first three fingers of the hand, measuring the 3 components in space of linear acceleration, angular velocity, and magnetic field. The lower limb device, SensFoot, is a device that integrates the same electronic components as the bracelet and is placed in a plastic housing shaped like a small rectangular parallelepiped that is placed over the shoe.
Interventions
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Motor Data Analysis
The SensMode System includes wearable devices for upper and lower limb motion analysis. The upper limb device, SensHand, consists of 3 sensorized elements: 2 sensorized rings to be placed at the level of the distal phalanx of the thumb and forefinger of the hand and 1 sensorized wristband to be placed at the level of the distal portion of the forearm near the wrist. Each element of SensHand allows the acquisition of inertial data with respect to the biomechanics of the arm-forearm-wrist and the first three fingers of the hand, measuring the 3 components in space of linear acceleration, angular velocity, and magnetic field. The lower limb device, SensFoot, is a device that integrates the same electronic components as the bracelet and is placed in a plastic housing shaped like a small rectangular parallelepiped that is placed over the shoe.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
* 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
50 Years
80 Years
ALL
Yes
Sponsors
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Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
OTHER
Responsible Party
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Filippo Cavallo
Associate Professor
Locations
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Ospedale Santa Maria Annunziata AUSL Toscana Centro
Bagno a Ripoli, Firenze, Italy
Azienda Ospedaliero Universitaria Careggi
Florence, , Italy
IRCCS Fondazione Don Carlo Gnocchi Firenze
Florence, , Italy
Ospedale Apuane AUSL Toscana Nord Ovest
Massa, , Italy
IRCCS Istituto Auxologico Italiano, Ospedale San Luca
Milan, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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OLIMPIA
Identifier Type: -
Identifier Source: org_study_id
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