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Assessment of the Evolution of Lumbar Spine Movement Fluidity Using Xsens Inertial Sensors in Subjects With Chronic Low Back Pain Before and After Rehabilitation

Без фазы С лечением Low Back Pain

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: X-sens sensor.
Кому может быть актуально
Состояния в реестре: Low Back Pain. Базовые параметры: 18 лет — 65 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
Франция
Следующий шаг
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Официальное название

Xmouv - Assessment of the Evolution of Lumbar Spine Movement Fluidity Using Xsens Inertial Sensors in Subjects With Chronic Low Back Pain Before and After Rehabilitation

Обзор

Low back pain, defined as pain located between the thoracolumbar junction and the lower gluteal fold, becomes chronic in 8% of patients. As the leading cause of disability worldwide, it has major individual and medico-economic consequences. Three-dimensional biomechanical analysis allows exploration of movement alterations related to low back pain. Although several parameters have already been studied (maximum joint range of motion (ROM), lumbopelvic rhythm, movement variability, gait), no consistent kinematic profile has emerged. Movement fluidity, assessed by the presence of jerks (brief movement disturbances), remains under-described despite its relevance in evaluating movement quality. Invistigators hypothesize that lumbar spine movement fluidity during flexion improves after a rehabilitation program and correlates with clinical response. This project stands out by exploring a rarely studied parameter (movement fluidity) and integrating it as a potential indicator for rehabilitation monitoring.

Вмешательства

  • Устройство X-sens sensor
    kinematic movement measurement using 5 Xsens inertial sensors (Awinda) placed on the head, thoracic vertebrae (T8), lumbar vertebrae (L1, L4), and sacrum (S1), before and after the rehabilitation program (ten working days). Movement will be measured during standardized tasks including 3 lumbar spine flexions and 3 right and left lumbar rotations. Movements will be recorded by the sensors at a frequency of 100 Hz.

Первичные конечные точки

  • Correlation between the evolution of trunk flexion movement fluidity and the evolution of disability before and after rehabilitation program [Срок оценки: 2 weeks]
Вторичные конечные точки (12)
  • Changes in range of motion (ROM) between the first and last day of rehabilitation program [Срок оценки: 2 weeks]
  • Changes in maximum angular velocity between the first and last day of rehabilitation program [Срок оценки: 2 weeks]
  • Changes in lumbopelvic rhythm between the first and last day of rehabilitation program [Срок оценки: 2 weeks]
  • Changes in functional disability between the first and last day of rehabilitation program [Срок оценки: 2 weeks]
  • Changes in pain between the first and last day of rehabilitation program [Срок оценки: 2 weeks]
  • Changes in psychological impact between the first and last day of rehabilitation program [Срок оценки: 2 weeks]
  • Changes in kinesiophobia between the first and last day of rehabilitation program [Срок оценки: 2 weeks]
  • Changes in catastrophizing between the first and last day of rehabilitation program [Срок оценки: 2 weeks]
  • Changes in fears and beliefs regarding work and physical activity between the first and last day of rehabilitation program [Срок оценки: 2 weeks]
  • Changes in Schober index between the first and last day of rehabilitation program [Срок оценки: 2 weeks]
  • Changes in fingertip-to-floor distance between the first and last day of rehabilitation program [Срок оценки: 2 weeks]
  • Changes in heel-to-buttock distance between the first and last day of rehabilitation program [Срок оценки: 2 weeks]

Критерии участия

Критерии включения

  • Age between 18 and 65 years inclusive
  • BMI between 18-30 kg/m²
  • Chronic low back pain lasting more than three months
  • Rehabilitation care in the Physical Medicine and Rehabilitation Department of Montpellier University Hospital

Критерии исключения

  • Sciatica episode within the last three months
  • Traumatic, tumoral, or infectious cause of low back pain
  • History of spinal, pelvic, or hip fracture
  • Inflammatory rheumatism
  • Lumbar arthrodesis
  • Severe scoliosis
  • Subject with a legal protection measure (guardianship, curatorship)
  • Subject under legal protection
  • Subject not affiliated to a social security system or not benefiting from such a system
  • Absence of informed written consent
  • Pregnant or breastfeeding women

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

Франция · 1 центр
  • University Hospital of Montpellier — Montpellier

Идентификаторы

NCT: NCT07327554 · RECHMPL25_0310 · 2025-A02160-49

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗