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

NCT06907589 | Recruiting

• 1 other identifier: OLIMPIA
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 5

Brief Summary

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

Parkinson Disease; Healthy Adult

Keywords

parkinson's disease; wearable sensors; motor data

Outcome Measures

Primary Outcomes (16)

• Number of repetitions

  Number of repetitions in Finger Tapping task

  at Enrollment (T0)

• Number of repetitions

  Number of repetitions in Thumb-ForeFinger Tapping task

  at Enrollment (T0)

• Number of repetitions

  Number of repetitions in Opening/Closing task

  at Enrollment (T0)

• Number of repetitions

  Number of repetitions in Pronosupination task

  at Enrollment (T0)

• Number of repetitions

  Number of repetitions in Toe Tapping task

  at Enrollment (T0)

• Number of repetitions

  Number of repetitions in Leg Agility task

  at Enrollment (T0)

• Number of repetitions

  Number of repetitions in Heel Tapping task

  at Enrollment (T0)

• Number of repetitions

  Number of repetitions in Heel-Toe Tapping task

  at Enrollment (T0)

• Time to Stand Up

  Time to stand up from a chair

  at Enrollment (T0)

• Gait Time

  Time to walk for 15 meters straight on

  at Enrollment (T0)

• Rotation Time

  Time to perform a turning of 360°

  at Enrollment (T0)

• Fundamental frequency of accelerometer signal

  Fundamental frequency of accelerometer signal for hands resting tremor task

  At enrollment (T0)

• Fundamental frequency of accelerometer signal

  Fundamental frequency of accelerometer signal for feet resting tremor task

  At enrollment (T0)

• Fundamental frequency of accelerometer signal

  Fundamental frequency of accelerometer signal for hands postural tremor task

  At enrollment (T0)

• Fundamental frequency of accelerometer signal

  Fundamental frequency of accelerometer signal for hands kinetic tremor task

  At enrollment (T0)

• Strides Number

  Number of strides to walk for 15 meters straight on

  at Enrollment (T0)

Study Arms (2)

Motor Data Analysis for Healthy Subjects

EXPERIMENTAL

All subjects who are recruited in the study undergo sensors administration for motor analysis at the enrollement

Device: Motor Data Analysis

Motor Data Analysis for patients with Parkinson's disease

EXPERIMENTAL

All subjects who are recruited in the study undergo sensors administration for motor analysis at the enrollement

Device: Motor Data Analysis

Interventions

Motor Data Analysis DEVICE

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 Healthy Subjects; Motor Data Analysis for patients with Parkinson's disease

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna: lead

Study Sites (5)

Ospedale Santa Maria Annunziata AUSL Toscana Centro

Bagno a Ripoli, Firenze, 50012, Italy

RECRUITING

Azienda Ospedaliero Universitaria Careggi

Florence, 50134, Italy

RECRUITING

IRCCS Fondazione Don Carlo Gnocchi Firenze

Florence, 50143, Italy

RECRUITING

Ospedale Apuane AUSL Toscana Nord Ovest

Massa, 54100, Italy

RECRUITING

IRCCS Istituto Auxologico Italiano, Ospedale San Luca

Milan, 20149, Italy

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Filippo Cavallo

CONTACT

+390552758663; filippo.cavallo@santannapisa.it

Erika Rovini

CONTACT

+390553758663; erika.rovini@unifi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 2, 2025
• Study Start: May 13, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 8, 2026
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (5)