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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 апреля 2026 г. обновлено: 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.

Обзор исследования

Статус

Завершенный

Условия

Болезнь Паркинсона

Подробное описание

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.

Тип исследования

Наблюдательный

Регистрация (Действительный)

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

Италия
- FI
  - Florence, FI, Италия, 50134
    - Dipartimento di Medicina Sperimentale e Clinica

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

Взрослый
Пожилой взрослый

Принимает здоровых добровольцев

Нет

Метод выборки

Невероятностная выборка

Исследуемая популяция

Patients with Parkinson disease

Описание

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)

Учебный план

В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Количество групп / когорт

Когорты и вмешательства

Группа / когорта
Patients with Parkinson disease diagnosis

Что измеряет исследование?

Первичные показатели результатов

Мера результата	Мера Описание	Временное ограничение
Participants assessed by BMR4Inertial wearable inertial sensor system Временное ограничение: 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) Временное ограничение: 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 Временное ограничение: 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

Другие показатели результатов

Мера результата	Мера Описание	Временное ограничение
Demographic variables Временное ограничение: Baseline	Date of Parkinson's diagnosis, age, education level, sex, most affected side	Baseline
The Montreal Cognitive Assessment Test - MoCA Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Francesca Cecchi

Соавторы

Fondazione Don Carlo Gnocchi Onlus

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

25 сентября 2025 г.

Первичное завершение (Действительный)

15 декабря 2025 г.

Завершение исследования (Действительный)

15 февраля 2026 г.

Даты регистрации исследования

Первый отправленный

30 мая 2025 г.

Впервые представлено, что соответствует критериям контроля качества

27 апреля 2026 г.

Первый опубликованный (Действительный)

5 мая 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)