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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 aprile 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

50

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Patients with Parkinson disease

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Patients with Parkinson disease diagnosis

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Participants assessed by BMR4Inertial wearable inertial sensor system
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Demographic variables
Lasso di tempo: Baseline
Date of Parkinson's diagnosis, age, education level, sex, most affected side
Baseline
The Montreal Cognitive Assessment Test - MoCA
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Francesca Cecchi

Collaboratori

Fondazione Don Carlo Gnocchi Onlus

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

25 settembre 2025

Completamento primario (Effettivo)

15 dicembre 2025

Completamento dello studio (Effettivo)

15 febbraio 2026

Date di iscrizione allo studio

Primo inviato

30 maggio 2025

Primo inviato che soddisfa i criteri di controllo qualità

27 aprile 2026

Primo Inserito (Effettivo)

5 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • INERTIAL

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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