Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06907589

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Healthy Adult Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale Santa Maria Annunziata AUSL Toscana Centro, Bagno a Ripoli, Firenze, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

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.

Primary outcomes

  1. Number of repetitions

    Time frame: at Enrollment (T0)

    Number of repetitions in Finger Tapping task

  2. Number of repetitions

    Time frame: at Enrollment (T0)

    Number of repetitions in Thumb-ForeFinger Tapping task

  3. Number of repetitions

    Time frame: at Enrollment (T0)

    Number of repetitions in Opening/Closing task

  4. Number of repetitions

    Time frame: at Enrollment (T0)

    Number of repetitions in Pronosupination task

  5. Number of repetitions

    Time frame: at Enrollment (T0)

    Number of repetitions in Toe Tapping task

  6. Number of repetitions

    Time frame: at Enrollment (T0)

    Number of repetitions in Leg Agility task

  7. Number of repetitions

    Time frame: at Enrollment (T0)

    Number of repetitions in Heel Tapping task

  8. Number of repetitions

    Time frame: at Enrollment (T0)

    Number of repetitions in Heel-Toe Tapping task

  9. Time to Stand Up

    Time frame: at Enrollment (T0)

    Time to stand up from a chair

  10. Gait Time

    Time frame: at Enrollment (T0)

    Time to walk for 15 meters straight on

  11. Rotation Time

    Time frame: at Enrollment (T0)

    Time to perform a turning of 360°

  12. Fundamental frequency of accelerometer signal

    Time frame: At enrollment (T0)

    Fundamental frequency of accelerometer signal for hands resting tremor task

  13. Fundamental frequency of accelerometer signal

    Time frame: At enrollment (T0)

    Fundamental frequency of accelerometer signal for feet resting tremor task

  14. Fundamental frequency of accelerometer signal

    Time frame: At enrollment (T0)

    Fundamental frequency of accelerometer signal for hands postural tremor task

  15. Fundamental frequency of accelerometer signal

    Time frame: At enrollment (T0)

    Fundamental frequency of accelerometer signal for hands kinetic tremor task

  16. Strides Number

    Time frame: at Enrollment (T0)

    Number of strides to walk for 15 meters straight on

Study contacts

Contact information is provided by the study sponsor or research team.

Erika Rovini

CONTACT

[email protected]

+390553758663

Filippo Cavallo

CONTACT

[email protected]

+390552758663

Sponsors and collaborators

Lead sponsor

Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna

Other

Registry information

Acronym: OLIMPIA

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 2, 2025
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.