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Parkinson DiseaseOLIMPIANCT06907589

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

A study testing Motor Data Analysis in people with Parkinson Disease and Healthy Adult, run by Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna at 5 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 50 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Parkinson Disease, Healthy Adult
What is being tested?
Motor Data Analysis
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
5 sitesItaly
Study dates
13 May 2024to 8 Jan 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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 join

  • 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
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  • 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
  • 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

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Filippo Cavallo contact

+390552758663

filippo.cavallo@santannapisa.it

Erika Rovini contact

+390553758663

erika.rovini@unifi.it

5 sites in 1 country

Italy5 sites, 5 recruiting

  • Ospedale Santa Maria Annunziata AUSL Toscana Centro

    Bagno a Ripoli, Firenze, 50012

    Paola Vanni, +390552313862, paola.vanni@uslcentro.toscana.it

    Recruiting

  • Azienda Ospedaliero Universitaria Careggi

    Florence, 50134

    Silvia Ramat, +390557947956, silvia.ramat@unifi.it

    Recruiting

  • IRCCS Fondazione Don Carlo Gnocchi Firenze

    Florence, 50143

    Gemma Lombardi, +3905557393917, glombardi@dongnocchi.it

    Recruiting

  • Ospedale Apuane AUSL Toscana Nord Ovest

    Massa, 54100

    Carlo Maremmani, +3905854931, carlo.maremmani@uslnordovest.toscana.it

    Recruiting

  • IRCCS Istituto Auxologico Italiano, Ospedale San Luca

    Milan, 20149

    Andrea Ciammola, +39026191129, a.ciammola@auxologico.it

    Recruiting

Other trials in Italy

About this study

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.

Being tested
Motor Data Analysis
Keywords
parkinson&amp;#39;s disease, wearable sensors, motor data
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Motor Data AnalysisDevice

    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.

Study groups in NCT06907589
Study groupRoleWhat they receive
Motor Data Analysis for Healthy SubjectsExperimentalAll subjects who are recruited in the study undergo sensors administration for motor analysis at the enrollement
Receives: Device: Motor Data Analysis
Motor Data Analysis for patients with Parkinson's diseaseExperimentalAll subjects who are recruited in the study undergo sensors administration for motor analysis at the enrollement
Receives: Device: Motor Data Analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of repetitions

    Number of repetitions in Finger Tapping task

    Measured: at Enrollment (T0)

  2. Number of repetitions

    Number of repetitions in Thumb-ForeFinger Tapping task

    Measured: at Enrollment (T0)

  3. Number of repetitions

    Number of repetitions in Opening/Closing task

    Measured: at Enrollment (T0)

  4. Number of repetitions

    Number of repetitions in Pronosupination task

    Measured: at Enrollment (T0)

  5. Number of repetitions

    Number of repetitions in Toe Tapping task

    Measured: at Enrollment (T0)

  6. Number of repetitions

    Number of repetitions in Leg Agility task

    Measured: at Enrollment (T0)

  7. Number of repetitions

    Number of repetitions in Heel Tapping task

    Measured: at Enrollment (T0)

  8. Number of repetitions

    Number of repetitions in Heel-Toe Tapping task

    Measured: at Enrollment (T0)

  9. Time to Stand Up

    Time to stand up from a chair

    Measured: at Enrollment (T0)

  10. Gait Time

    Time to walk for 15 meters straight on

    Measured: at Enrollment (T0)

  11. Rotation Time

    Time to perform a turning of 360°

    Measured: at Enrollment (T0)

  12. Fundamental frequency of accelerometer signal

    Fundamental frequency of accelerometer signal for hands resting tremor task

    Measured: At enrollment (T0)

  13. Fundamental frequency of accelerometer signal

    Fundamental frequency of accelerometer signal for feet resting tremor task

    Measured: At enrollment (T0)

  14. Fundamental frequency of accelerometer signal

    Fundamental frequency of accelerometer signal for hands postural tremor task

    Measured: At enrollment (T0)

  15. Fundamental frequency of accelerometer signal

    Fundamental frequency of accelerometer signal for hands kinetic tremor task

    Measured: At enrollment (T0)

  16. Strides Number

    Number of strides to walk for 15 meters straight on

    Measured: at Enrollment (T0)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2025
  2. Study start13 May 2024
  3. Primary completionJan 2026 (estimated)
  4. Study completion8 Jan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06907589
Sponsor's protocol ID
OLIMPIA
Acronym
OLIMPIA
Status last verified
Mar 2025
First submitted
26 Mar 2025
Last updated
2 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Motor Data Analysis in people with Parkinson Disease and Healthy Adult, run by Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna at 5 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Filippo Cavallo (+390552758663, filippo.cavallo@santannapisa.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of repetitions (time frame: at Enrollment (T0)). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06907589.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.

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