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

Overview

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.

Interventions

• 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

Primary outcome measures

• Number of repetitions [Time frame: at Enrollment (T0)]
• Number of repetitions [Time frame: at Enrollment (T0)]
• Number of repetitions [Time frame: at Enrollment (T0)]
• Number of repetitions [Time frame: at Enrollment (T0)]
• Number of repetitions [Time frame: at Enrollment (T0)]
• Number of repetitions [Time frame: at Enrollment (T0)]
• Number of repetitions [Time frame: at Enrollment (T0)]
• Number of repetitions [Time frame: at Enrollment (T0)]
• Time to Stand Up [Time frame: at Enrollment (T0)]
• Gait Time [Time frame: at Enrollment (T0)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Device feasibility

Study locations

Italy · 5 centers

• Ospedale Santa Maria Annunziata AUSL Toscana Centro — Bagno a Ripoli
• Azienda Ospedaliero Universitaria Careggi — Florence
• IRCCS Fondazione Don Carlo Gnocchi Firenze — Florence
• Ospedale Apuane AUSL Toscana Nord Ovest — Massa
• IRCCS Istituto Auxologico Italiano, Ospedale San Luca — Milan

Identifiers

NCT: NCT06907589 · OLIMPIA

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗