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Набор скоро начнётся NCT07133100

Evaluating Upper Limb Movement Precision With AuReha in People With One-Sided Motor Impairment

Без фазы С лечением Shoulder Posterior Instability Shoulder Anterior Instability Shoulder Anterior Latarjet Instability Adhesive Capsulitis, Shoulder

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Upper limb rehabilitation wearable device.
Кому может быть актуально
Состояния в реестре: Shoulder Posterior Instability, Shoulder Anterior Instability, Shoulder Anterior Latarjet Instability, Adhesive Capsulitis, Shoulder. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
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Официальное название

Intrasubject Evaluation of Upper Limb Movement Precision Using the AuReha System in Individuals With Unilateral Motor Impairment

Обзор

The clinical investigation is designed as a controlled, two-arm, intra-patient, non-randomized interventional study aimed at assessing the capabilities of the AuReha system in detecting upper limb movement precision in patients with unilateral proprioceptive impairment. The comparison will be conducted within the same subject, between the healthy limb and the impaired limb, through the execution of proprioceptive exercises in an open kinetic chain. The biomechanical parameters collected will include movement precision, trunk stability, compensatory movements, and joint range of motion. In addition to the quantitative analysis, qualitative data will also be collected regarding usability, wearability, and user experience of the system through questionnaires administered to both patients and healthcare professionals. The study will be conducted at the Shoulder Team Outpatient Clinic in Forlì, enrolling approximately 52 patients.

Подробное описание

The primary goal of this clinical investigation is to support the CE certification process of the AuReha system, a wearable medical device designed for monitoring upper limb movement during rehabilitation.

Specifically, the study aims to assess the movement precision of the upper limb in individuals with unilateral motor impairment. The main objective is to compare, within the same individual, the movement accuracy of the healthy arm versus the impaired arm during a series of rehabilitation exercises guided by the AuReha system.

Secondary objectives include:

* Evaluating the usability of the AuReha system in clinical practice from the perspective of healthcare professionals using the Healthcare Systems Usability Scale (HSUS) and additional targeted questions. * Assessing patients' user experience during proprioceptive exercises, through the System Usability Scale (SUS), the User Engagement Scale - Short Form (UES-SF), and other custom questions. * Characterizing the wearability of the device by matching shirt sizes with patients' anthropometric measurements, using both direct observations and questionnaires. * Analyzing the movement data collected during a specific reaching task prompted by the AuReha system, to gain deeper insight into the quality and precision of the movement performed.

These aspects aim to demonstrate the system's ability to support an optimized rehabilitation process. AuReha is designed to help patients perform their prescribed rehabilitation exercises correctly while collecting detailed biomechanical data. This allows clinicians to closely monitor the patient's response to therapy and make data-driven decisions throughout the recovery process.

Вмешательства

  • Устройство Upper limb rehabilitation wearable device
    The intervention consists in using the AuReha system to perform a series of upper limb rehabilitation exercises. No therapeutic or diagnostic interventions will be administered, as this is a non-invasive study focused on system validation and user feedback.

Первичные конечные точки

  • Evaluation of the intra-subject difference in movement accuracy during a target-reaching exercise proposed by the AuReha system, between the healthy limb and the limb affected by motor deficit [Срок оценки: Day 1]
Вторичные конечные точки (9)
  • Characterization of AuReha in measuring trunk stability [Срок оценки: Day 1]
  • Characterization of AuReha in measuring limb compensation [Срок оценки: Day 1]
  • Characterization of AuReha in measuring the distance to a specified target [Срок оценки: Day 1]
  • Characterization of AuReha in measuring the duration of the movement [Срок оценки: Day 1]
  • Characterization of AuReha in terms of usability for patients with the System Usability Scale (SUS) [Срок оценки: Day 1]
  • Characterization of AuReha in terms of usability for patients with the User Engagement Scale - Short Form (UES-SF) [Срок оценки: Day 1]
  • Characterization of AuReha in terms of usability for patients [Срок оценки: Day 1]
  • Characterization of AuReha in terms of usability for healthcare professionals [Срок оценки: Day 1]
  • Correlation between AuReha shirt size (categorical: XS, S, M, L,) and the anthropometric measurements of healthy volunteers (in cm) [Срок оценки: Day 1]

Критерии участия

Критерии включения

  • patients with a healthy contralateral limb
  • patients affected by orthopedic shoulder conditions such as posterior instability, anterior instability, anterior Latarjet instability, adhesive capsulitis, or prostheses
  • age ≥18 years
  • patients who consent to participate in the study by signing the informed consent form

Критерии исключения

  • Pregnant and/or breastfeeding women (verified through self-declaration)
  • Epilepsy
  • Allergy or hypersensitivity to materials used in the medical device, specifically: polypropylene and lycra (fabric), nylon (integrated zipper), viscose and elastane (zipper integration fabric)
  • Chronic headache under treatment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Италия · 1 центр
  • Poliambulatorio Shoulder Team — Forlì

Идентификаторы

NCT: NCT07133100 · DigitalRehab_01_2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗