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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 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

50

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Patients with Parkinson disease

Beschreibung

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)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Patients with Parkinson disease diagnosis

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Participants assessed by BMR4Inertial wearable inertial sensor system
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Demographic variables
Zeitfenster: Baseline
Date of Parkinson's diagnosis, age, education level, sex, most affected side
Baseline
The Montreal Cognitive Assessment Test - MoCA
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Francesca Cecchi

Mitarbeiter

Fondazione Don Carlo Gnocchi Onlus

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

25. September 2025

Primärer Abschluss (Tatsächlich)

15. Dezember 2025

Studienabschluss (Tatsächlich)

15. Februar 2026

Studienanmeldedaten

Zuerst eingereicht

30. Mai 2025

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

27. April 2026

Zuerst gepostet (Tatsächlich)

5. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

5. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

27. April 2026

Zuletzt verifiziert

1. April 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • INERTIAL

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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