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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorScuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: Motor Data Analysis for Healthy SubjectsExperimental treatment 1 intervention
Group B: Motor Data Analysis for patients with Parkinson's diseaseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of repetitions

Number of repetitions in Finger Tapping task

Time frame
at Enrollment (T0)
2

Number of repetitions

Number of repetitions in Thumb-ForeFinger Tapping task

Time frame
at Enrollment (T0)
3

Number of repetitions

Number of repetitions in Opening/Closing task

Time frame
at Enrollment (T0)
4

Number of repetitions

Number of repetitions in Pronosupination task

Time frame
at Enrollment (T0)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.