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

27. april 2026 opdateret af: Francesca Cecchi

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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

50

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Italien
    • FI
      • Florence, FI, Italien, 50134
        • Dipartimento di Medicina Sperimentale e Clinica

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients with Parkinson disease

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Patients with Parkinson disease diagnosis

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Participants assessed by BMR4Inertial wearable inertial sensor system
Tidsramme: 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.
Baseline
MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Tidsramme: 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.
At least 15 minutes after baseline
Participants assessed by BMR4Inertial wearable inertial sensor system
Tidsramme: 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.
At least 30 minutes after baseline

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Demographic variables
Tidsramme: Baseline
Date of Parkinson's diagnosis, age, education level, sex, most affected side
Baseline
The Montreal Cognitive Assessment Test - MoCA
Tidsramme: 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.
Baseline
Scale of clinical instability - SIC
Tidsramme: 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
Baseline
Hoehn e Yahr scale
Tidsramme: 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.
Baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Francesca Cecchi

Samarbejdspartnere

Fondazione Don Carlo Gnocchi Onlus

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

25. september 2025

Primær færdiggørelse (Faktiske)

15. december 2025

Studieafslutning (Faktiske)

15. februar 2026

Datoer for studieregistrering

Først indsendt

30. maj 2025

Først indsendt, der opfyldte QC-kriterier

27. april 2026

Først opslået (Faktiske)

5. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • INERTIAL

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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