Reliability and Validity of Sensor-derived Measurements in Individuals With Parkinson's Disease: Preliminary Results From the INERTIAL Study

NCT07567079 | Completed DMC

• 1 other identifier: INERTIAL
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Parkinson's disease (PD) is a neurodegenerative disorder that affects a significant portion of the elderly population. Gait disturbance is a core symptom of the disease and can impact stride length and height, gait speed, trunk sway, and the pendular movement of the arms. This impairment is often accompanied by postural alterations, balance difficulties, and an increased risk of falls. Additionally, freezing and festination phenomena may also occur. Inertial Movement Units are inertial sensors that are used for monitoring clinical and identification of movement biomarkers in patients with neurodegenerative diseases. In particular, among existing devices based on IMUs, prototype versions of SensMode have shown promising results in identifying objective indices to support diagnosis and monitoring in patients with PD. Recent work shows that the aforementioned wearable sensors during some tasks of the MDS-UPDRS have excellent discriminative property between subjects healthy and those with PD. The aim of the present research project is to investigate the potential of sensors in measuring limb movement in subjects with Parkinson's Disease.

Conditions

Parkinson Disease

Keywords

Parkinson disease; motor sensor; motion sensors

Outcome Measures

Primary Outcomes (3)

• Participants assessed by BMR4Inertial wearable inertial sensor system

  The Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS Part III) motor examination is acquired using the BMR4Inertial wearable inertial sensor system. The following MDS-UPDRS Part III items are assessed through the experimental setup: finger tapping, hand movements, pronation-supination movements of the hands, toe tapping, leg agility, arising from chair, gait, postural tremor of the hands, kinetic tremor of the hands, rest tremor amplitude, and constancy of rest tremor. Raw inertial signals are acquired using wearable sensors and processed to obtain quantitative sensor-derived measures of motor performance.

  Baseline

• MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

  The Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS Part III) motor examination is acquired using the BMR4Inertial wearable inertial sensor system. The following MDS-UPDRS Part III items are assessed through the experimental setup: finger tapping, hand movements, pronation-supination movements of the hands, toe tapping, leg agility, arising from chair, gait, postural tremor of the hands, kinetic tremor of the hands, rest tremor amplitude, and constancy of rest tremor. Raw inertial signals are acquired using wearable sensors and processed to obtain quantitative sensor-derived measures of motor performance.

  At least 15 minutes after baseline

• Participants assessed by BMR4Inertial wearable inertial sensor system

  The Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS Part III) motor examination is acquired using the BMR4Inertial wearable inertial sensor system. The following MDS-UPDRS Part III items are assessed through the experimental setup: finger tapping, hand movements, pronation-supination movements of the hands, toe tapping, leg agility, arising from chair, gait, postural tremor of the hands, kinetic tremor of the hands, rest tremor amplitude, and constancy of rest tremor. Raw inertial signals are acquired using wearable sensors and processed to obtain quantitative sensor-derived measures of motor performance.

  At least 30 minutes after baseline

Other Outcomes (4)

• Demographic variables

  Baseline

• The Montreal Cognitive Assessment Test - MoCA

  Baseline

• Scale of clinical instability - SIC

  Baseline

Study Arms (1)

Patients with Parkinson disease diagnosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Parkinson disease

You may qualify if:

• Age greater than or equal to 18 years
• Diagnosis of Parkinson's disease (PD) according to Postuma criteria
• Hoehn and Yahr stages I-IV
• Signed informed consent provided by the participant or, when necessary, by a legal guardian or court-appointed representative

You may not qualify if:

• Severe comorbid conditions that may alter the subject's motor function
• Cognitive impairment severe enough to prevent cooperation during the execution of the protocol
• Presence of clinical instability, defined as a score greater than zero on the Clinical Instability Scale (CIS)

Sponsors & Collaborators

• Francesca Cecchi: lead
• Fondazione Don Carlo Gnocchi Onlus: collaborator

Study Sites (1)

Dipartimento di Medicina Sperimentale e Clinica

Florence, FI, 50134, Italy

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: May 5, 2026
• Study Start: September 25, 2025
• Primary Completion: December 15, 2025
• Study Completion: February 15, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

IT (1)