跳至主要内容
临床试验/NCT07036120
NCT07036120招募中不适用

A Study on the Biomechanical Mechanisms of Orthotic/Physical Training Correction of Hallux Valgus and Its Impact on the Lower Limbs

Wan Xinzhu1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年7月3日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
1
主要终点
Measuring kinematic synergy using optical infrared cameras

研究概览

简要总结

The study population of this project is mainly young people. Our goal is to investigate the kinematic and kinetic characterization brought about by different conservative treatment modalities for hallux valgus. The main study involves recruiting volunteers, grouping them into 12-week interventions with orthotics or foot exercises, and analyzing the kinematic and kinetic alterations in young and middle-aged subjects before, during, and after cessation of the interventions by motion capture, surface electromyography, and musculoskeletal ultrasound. A database of human biomechanical characteristics was constructed through in-vivo exercise techniques to analyze changes in the biomechanical characteristics of the population with hallux valgus after the use of different intervention methods.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Hallux valgus angle > 15°
  • Age 18-45 years
  • Right leg dominant (based on the Waterloo Foot Questionnaire)
  • Bilateral hallux valgus

排除标准

  • History of lower limb surgery or neuromuscular diseases causing gait abnormalities (such as lumbar disc herniation and chronic ankle instability)
  • Any treatment for hallux valgus within the past 3 months

结局指标

主要结局

Measuring kinematic synergy using optical infrared cameras

时间窗: From baseline to 12 weeks of intervention

The Pearson correlation coefficient (r) was used to measure the independence of individual modules and the consistency of synergistic effects among individuals in the same group. When r \> 0.7, it was considered that there was similarity between the two synergy modules. Degree of freedom (DoF) with a median value \> 0.25 in the spatial components of the module were considered to be activated DoF in that module.

Measuring muscle synergy using a 16-channel surface electromyography device

时间窗: From baseline to 12 weeks of intervention

The Pearson correlation coefficient (r) was used to measure the independence of individual modules and the consistency of synergistic effects among individuals in the same group. When r \> 0.7, it was considered that there was similarity between the two synergy modules. Muscles with a median value \> 0.3 in the spatial components of the module were considered to be activated muscles in that module.

Measuring muscle synergy using a 16-channel surface electromyography device

时间窗: From baseline to 12 weeks of intervention

The Pearson correlation coefficient (r) was used to measure the independence of individual modules and the consistency of synergistic effects among individuals in the same group. When r \> 0.7, it was considered that there was similarity between the two synergy modules. Muscles with a median value \> 0.3 in the spatial components of the module were considered to be activated muscles in that module.

Measuring kinematic synergy using optical infrared cameras

时间窗: From baseline to 12 weeks of intervention

The Pearson correlation coefficient (r) was used to measure the independence of individual modules and the consistency of synergistic effects among individuals in the same group. When r \> 0.7, it was considered that there was similarity between the two synergy modules. Degree of freedom (DoF) with a median value \> 0.25 in the spatial components of the module were considered to be activated DoF in that module.

次要结局

  • Using ultrasound diagnostic system to capture a cross-sectional image of the thickest part of the muscle for measuring the cross-sectional area of the muscle(From baseline to 12 weeks of intervention)
  • Using a force plate to measure the center of foot pressure(From baseline to 12 weeks of intervention)
  • Measuring hallux valgus angle with a protractor(From baseline to 12 weeks of intervention)
  • Measuring hallux valgus angle with a protractor(From baseline to 12 weeks of intervention)
  • Using a force plate to measure the center of foot pressure(From baseline to 12 weeks of intervention)

研究者

发起方
Wan Xinzhu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Wan Xinzhu

Principal Investigator, Master's Candidate, Department of Basic Medical Sciences, Southern Medical University

Southern Medical University, China

研究点 (1)

Loading locations...

相似试验

A Study on the Biomechanical Mechanisms of... | 临床试验