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Набор скоро начнётся NCT07117292

Assessing the Validity and Reliability of IMU Systems and a Goniometer in Cervical Motion (VIRGO-CM)

Без фазы С лечением Cervical Spine Motion Assessment in Healthy Adults

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: Xsens DOT, Trigno Avanti Sensors, Universal Goniometer.
Кому может быть актуально
Состояния в реестре: Cervical Spine Motion Assessment in Healthy Adults. Базовые параметры: 18 лет — 40 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
Cyprus
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Assessing the Validity and Reliability of Two IMU Sensor Systems and a Goniometer in Multi-Planar Cervical Motion

Обзор

This study aims to evaluate how accurate and reliable two wearable sensor systems (inertial measurement units or IMUs) and a goniometer are in measuring cervical spine (neck) motion. Healthy adult volunteers will be asked to perform simple head movements in different directions while being assessed using the devices. The goal is to compare how closely these tools agree with each other and how consistently they record motion across repeated tests. This information will help determine whether the sensors are suitable for use in clinical settings to assess neck movement in future patient populations.

Подробное описание

This interventional validation study will assess the concurrent validity and test-retest reliability of two inertial measurement unit (IMU) systems (Xsens DOT and Trigno Avanti) and a universal goniometer in measuring multi-planar cervical motion. A within-subject design will be used, with participants performing standardized active cervical range of motion (AROM) tasks in flexion, extension, lateral flexion, and rotation. All measurements will be conducted in a biomechanics lab setting under controlled conditions.

Each participant will undergo three testing sessions:

Familiarization session (optional)

Test session 1

Test session 2

Primary outcomes will include:

Peak angular displacement in each movement plane

Inter-device agreement (validity)

Intra-device test-retest consistency (reliability)

Sensor placement will follow anatomical landmarks based on previous biomechanical research. The IMUs and goniometer will be used simultaneously to compare measurements. Data analysis will involve intraclass correlation coefficients (ICC), standard error of measurement (SEM), and Bland-Altman plots for agreement analysis.

The study will recruit 20-30 healthy adults aged 18-40 with no current or past neck injury. The results will inform future clinical applications of wearable sensors in cervical spine assessment, particularly for populations with neck pain or neuromusculoskeletal disorders.

Ethical approval has been granted by the Cyprus National Bioethics Committee (Approval: ΕΕΒΚ ΕΠ 2025.01.231), and all participants will provide written informed consent.

Вмешательства

  • Устройство Xsens DOT
    Wearable inertial sensor used to capture cervical range of motion in three planes.
  • Устройство Trigno Avanti Sensors
    Wearable inertial sensor used to capture cervical range of motion in three planes.
  • Устройство Universal Goniometer
    Standard clinical tool used to measure cervical spine motion angles manually.

Первичные конечные точки

  • Agreement in Cervical Range of Motion between IMUs and Goniometer [Срок оценки: Day 1 (single-session assessment)]
  • Test-Retest Reliability of IMU Systems in Cervical Range of Motion [Срок оценки: Day 1 (two repeated assessments within same session)]

Критерии участия

Критерии включения

  • Healthy adults aged 18 to 40 years
  • Able to understand and follow instructions
  • Provided informed consent

Критерии исключения

  • History of cervical spine pathology, trauma, or surgery
  • Presence of neck pain, musculoskeletal, neurological, or vestibular disorders
  • Use of medications affecting sensorimotor function
  • Pregnancy
  • Any condition that may interfere with safe participation or data accuracy

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

Cyprus · 1 центр
  • European University Cyprus — Nicosia

Идентификаторы

NCT: NCT07117292 · ΕΕΒΚ ΕΠ 2025.01.231

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗