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临床试验/NCT07417345
NCT07417345已完成不适用

Biomechanical Analysis of Gait in Individuals With Low Back Pain

Arrate Pinto Carral1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
74
试验地点
1
主要终点
Step and stride length

研究概览

简要总结

The goal of this observational case-control study is to learn whether low back pain is associated with changes in gait and related clinical characteristics in adults over 18 years old. The main questions it aims to answer are:

  • Are gait biomechanics different in people with low back pain compared with people without low back pain?
  • Are pain intensity, psychosocial risk, and physical activity levels different between both groups? Participants will complete questionnaires about low back pain, physical activity, and health status, and will perform a walking test in a motion analysis laboratory where gait parameters are recorded.

详细描述

This study is an observational case-control investigation designed to explore the relationship between low back pain and gait biomechanics in adults. Low back pain is a common health problem that may affect movement patterns, physical function, and daily activities. Understanding how gait is modified in people with low back pain may help to improve assessment and rehabilitation strategies.

Participants will be divided into two groups: adults with low back pain and adults without low back pain. Sociodemographic and clinical characteristics will be collected to describe the sample and to allow comparisons between groups. The study will focus on the analysis of spatiotemporal, kinematic, and dynamic gait parameters obtained in a motion analysis laboratory.

Gait assessment will be performed using a three-dimensional motion capture system. In addition to gait analysis, participants will provide information about their health status, pain characteristics, physical activity, and psychosocial factors through self-report questionnaires. These variables will be used to describe the clinical profile of the participants and to examine potential associations with gait outcomes.

Comparisons between the low back pain group and the control group will be conducted to identify differences in gait biomechanics and clinical characteristics.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

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

入选标准

  • Adults aged 18 years or older.
  • Ability to read and understand Spanish.
  • For the low back pain group: current low back pain or low back pain within the last month lasting at least 24 hours.
  • For the control group: absence of current low back pain and no episode of low back pain during the previous month.
  • Willingness to participate and provision of written informed consent.

排除标准

  • Presence of leg pain or radicular symptoms (sciatica).
  • Pregnancy or childbirth within the last 12 months.
  • Previous lumbar spine surgery.
  • History of cancer, spinal tumor, or spinal infection.
  • Vertebral compression fracture.
  • Central nervous system disease.
  • Cauda equina syndrome.
  • Abdominal aortic aneurysm.
  • Any surgery or traumatic injury of the lower limbs within the last 5 years.
  • Any medical condition that could affect gait performance.

研究组 & 干预措施

Low Back Pain Group

Adults over 18 years with current or recent low back pain without leg pain, who undergo clinical assessment and gait analysis in a motion laboratory.

Control Group

Adults over 18 years without low back pain who undergo the same clinical assessment and gait analysis as the low back pain group.

结局指标

主要结局

Step and stride length

时间窗: Baseline

Step length and stride length measured in meters (m) during gait analysis

Cadence

时间窗: Baseline

Number of steps per minute during walking recorded with motion capture system (steps/min)

Temporal gait parameters

时间窗: Baseline

Stance time and gait cycle time measured in seconds during gait

Gait speed

时间窗: At baseline assessment

Mean walking speed during gait measured in meters per second (m/s) using 3D motion analysis.

Pelvis kinematics

时间窗: Baseline

Pelvic angles during gait in sagittal, frontal, and transverse planes, reported as maximum angle, minimum angle, and range of motion (ROM calculated as max-min). Measured in degrees.

Hip kinematics

时间窗: Baseline

Hip joint angles during gait in sagittal, frontal, and transverse planes, reported as maximum angle, minimum angle, and range of motion (ROM = max-min). Measured in degrees.

Knee kinematics

时间窗: Baseline

Knee joint angles during gait in sagittal, frontal, and transverse planes, reported as maximum angle, minimum angle, and range of motion (ROM = max-min). Measured in degrees.

Ankle kinematics

时间窗: Baseline

Ankle joint angles during gait in sagittal, frontal, and transverse planes, reported as maximum angle, minimum angle, and range of motion (ROM = max-min). Measured in degrees.

次要结局

  • Pain intensity - Numeric Pain Rating Scale (NPRS)(Baseline)
  • Psychosocial risk - STarT Back Screening Tool (SBST)(Baseline)
  • Physical activity level - International Physical Activity Questionnaire (IPAQ-SF)(Baseline)
  • Hip flexor (iliopsoas) shortening - Modified Thomas Test(Baseline)
  • Rectus femoris shortening - Modified Thomas Test(Baseline)

研究者

发起方
Arrate Pinto Carral
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Arrate Pinto Carral

Permanent Lecturer, Department of Nursing and Physiotherapy, University of León

Universidad de León

研究点 (1)

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