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临床试验/NCT07327554
NCT07327554招募中不适用

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

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2026年2月23日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
25
试验地点
1
主要终点
Correlation between the evolution of trunk flexion movement fluidity and the evolution of disability before and after rehabilitation program

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Compare Movement Fluidity Before and After Rehabilitation

Experimental

Evolution of Movement Fluidity Before and After Rehabilitation in patients with chronic low back pain

干预措施: X-sens sensor (Device)

结局指标

主要结局

Correlation between the evolution of trunk flexion movement fluidity and the evolution of disability before and after rehabilitation program

时间窗: 2 weeks

Movement velocity will be measured during flexion using Xsens inertial measurement units (head, T8, L1, L4, S1). Velocity profiles will identify acceleration and deceleration phases. Movement fluidity will be quantified by a normalized jerk metric: the count of local minima and maxima on the angular velocity curve divided by flexion/extension duration (peaks/s). This normalization accounts for variations in movement speed between individuals and measurement sessions, providing a standardized measure of movement smoothness where lower values indicate more fluid motion. Disability will be measured by the change in the score of Oswestry Disability Index (ODI) questionary between the first and last day of rehabilitation. The ODI questionary contains ten topics concerning intensity of pain and activities of daily life. Each question is scored on a scale of 0-5 where zero indicates the least amount of disability and 5 indicating most severe disability. The ODI scale range from 0 to 100

次要结局

  • Changes in lumbopelvic rhythm between the first and last day of rehabilitation program(2 weeks)
  • Changes in range of motion (ROM) between the first and last day of rehabilitation program(2 weeks)
  • Changes in popliteal angle between the first and last day of rehabilitation program(2 weeks)
  • Changes in maximum angular velocity between the first and last day of rehabilitation program(2 weeks)
  • Changes in functional disability between the first and last day of rehabilitation program(2 weeks)
  • Changes in pain between the first and last day of rehabilitation program(2 weeks)
  • Changes in psychological impact between the first and last day of rehabilitation program(2 weeks)
  • Changes in fingertip-to-floor distance between the first and last day of rehabilitation program(2 weeks)
  • Changes in kinesiophobia between the first and last day of rehabilitation program(2 weeks)
  • Changes in catastrophizing between the first and last day of rehabilitation program(2 weeks)
  • Changes in fears and beliefs regarding work and physical activity between the first and last day of rehabilitation program(2 weeks)
  • Changes in Schober index between the first and last day of rehabilitation program(2 weeks)
  • Changes in heel-to-buttock distance between the first and last day of rehabilitation program(2 weeks)
  • Changes in Sorensen test between the first and last day of rehabilitation program(2 weeks)
  • Changes in Shirado test between the first and last day of rehabilitation program(2 weeks)
  • Changes in isometric endurance of trunk muscles between the first and last day of rehabilitation program(2 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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