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NCT Number: NCT07567079

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dipartimento di Medicina Sperimentale e Clinica

Florence, FI, 50134, Italy

About this study

In detail, the primary objective of this project is to evaluate the reliability of measurements obtained from sensors used for measuring limb movement in subjects with PD. Specifically, the inter-rater and intra-rater reliability of measurements recorded with inertial sensor, during the execution of some items of Section III of the MDS-UPDRS. In addition, the study aims to assess the validity of the measurements obtained from the inertial sensor set by comparing them with clinical data in a sample of patients with PD.

Specifically, the objectives of the study are as follows:

  • The verification of the reliability of sensor-derived measurements; in particular, the inter-rater and intra-rater reliability of measurements recorded with inertial sensor, while performing of some items of Section III of the MDS-UPDRS.
  • The verification of the validity (criterion validity) of the experimental device-derived measurements during the execution of the items of Section III of the MDS-UPDRS involving limbs.

The data to be collected will include: demographic variables, clinical variables (Montreal Cognitive Assessment - MoCA; Clinical Instability Scale - CIS; Hoehn and Yahr stage - H&Y; MDS-UPDRS Part III), instrumental variables (recorded by inertial sensors). Inclusion criteria for participant selection are: age over 18 years, diagnosis of PD according to the Postuma criteria, Hoehn and Yahr stages I-IV, and signed informed consent. Exclusion criteria include: presence of severe comorbidities, significant cognitive impairment, or signs of clinical instability.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Primary outcomes

  1. Participants assessed by BMR4Inertial wearable inertial sensor system

    Time frame: Baseline

    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.

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

    Time frame: At least 15 minutes after baseline

    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.

  3. Participants assessed by BMR4Inertial wearable inertial sensor system

    Time frame: At least 30 minutes after baseline

    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.

Other outcomes

  1. Demographic variables

    Time frame: Baseline

    Date of Parkinson's diagnosis, age, education level, sex, most affected side

  2. The Montreal Cognitive Assessment Test - MoCA

    Time frame: Baseline

    The Montreal Cognitive Assessment (MoCA) is a screening tool that evaluates multiple cognitive domains, including attention, visuoconstructive abilities, memory, language, executive functions, numeracy, and orientation. It has been validated for the assessment of cognitive impairment in individuals with Parkinson's disease.

    Scores range from 0 to 30, with higher scores indicating better cognitive function.

  3. Scale of clinical instability - SIC

    Time frame: Baseline

    it is a rapid-response scale used to test the degree of clinical instability. It has a score ranging from 0-5 where 0 indicates a condition requiring clinical monitoring of more than 60 days and 5 a multi-day monitoring

  4. Hoehn e Yahr scale

    Time frame: Baseline

    it is the most commonly used scale to describe the progression of Parkinson's disease. The modified version of the scale consists of a seven-point scoring distributed over 5 stages of severity where 1 corresponds to a unilateral manifestation of the disease and 5 to wheelchair or bed confinement.

Sponsors and collaborators

Lead sponsor

Francesca Cecchi

Other

Collaborators

  • Fondazione Don Carlo Gnocchi ETS

Registry information

Acronym: INERTIAL

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
May 5, 2026
Registry last updated
May 5, 2026

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.

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