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 (OLIMPIA)

March 26, 2025 updated by: Filippo Cavallo, Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Italy
      • Firenze, Italy, 50134
        • Recruiting
        • Azienda Ospedaliero Universitaria Careggi
        • Contact:
      • Firenze, Italy, 50143
        • Recruiting
        • IRCCS Fondazione Don Carlo Gnocchi Firenze
        • Contact:
      • Massa, Italy, 54100
      • Milano, Italy, 20149
        • Recruiting
        • IRCCS Istituto Auxologico Italiano, Ospedale San Luca
        • Contact:
    • Firenze
      • Bagno a Ripoli, Firenze, Italy, 50012

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Motor Data Analysis for Healthy Subjects
All subjects who are recruited in the study undergo sensors administration for motor analysis at the enrollement
Device: 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.
Experimental: 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
Device: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of repetitions
Time Frame: at Enrollment (T0)
Number of repetitions in Finger Tapping task
at Enrollment (T0)
Number of repetitions
Time Frame: at Enrollment (T0)
Number of repetitions in Thumb-ForeFinger Tapping task
at Enrollment (T0)
Number of repetitions
Time Frame: at Enrollment (T0)
Number of repetitions in Opening/Closing task
at Enrollment (T0)
Number of repetitions
Time Frame: at Enrollment (T0)
Number of repetitions in Pronosupination task
at Enrollment (T0)
Number of repetitions
Time Frame: at Enrollment (T0)
Number of repetitions in Toe Tapping task
at Enrollment (T0)
Number of repetitions
Time Frame: at Enrollment (T0)
Number of repetitions in Leg Agility task
at Enrollment (T0)
Number of repetitions
Time Frame: at Enrollment (T0)
Number of repetitions in Heel Tapping task
at Enrollment (T0)
Number of repetitions
Time Frame: at Enrollment (T0)
Number of repetitions in Heel-Toe Tapping task
at Enrollment (T0)
Time to Stand Up
Time Frame: at Enrollment (T0)
Time to stand up from a chair
at Enrollment (T0)
Gait Time
Time Frame: at Enrollment (T0)
Time to walk for 15 meters straight on
at Enrollment (T0)
Rotation Time
Time Frame: at Enrollment (T0)
Time to perform a turning of 360°
at Enrollment (T0)
Fundamental frequency of accelerometer signal
Time Frame: At enrollment (T0)
Fundamental frequency of accelerometer signal for hands resting tremor task
At enrollment (T0)
Fundamental frequency of accelerometer signal
Time Frame: At enrollment (T0)
Fundamental frequency of accelerometer signal for feet resting tremor task
At enrollment (T0)
Fundamental frequency of accelerometer signal
Time Frame: At enrollment (T0)
Fundamental frequency of accelerometer signal for hands postural tremor task
At enrollment (T0)
Fundamental frequency of accelerometer signal
Time Frame: At enrollment (T0)
Fundamental frequency of accelerometer signal for hands kinetic tremor task
At enrollment (T0)
Strides Number
Time Frame: at Enrollment (T0)
Number of strides to walk for 15 meters straight on
at Enrollment (T0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 13, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 8, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 2, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OLIMPIA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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