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临床试验/NCT04462432
NCT04462432Unknown不适用

Spatiotemporal Characteristics and Multi-body Dynamics Modeling of Gait Touch Information After Anterior Cruciate Ligament Rupture and Reconstruction

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2017年3月2日最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
1
主要终点
walking speed

研究概览

简要总结

High incidence rate of knee osteoarthritis and gait analysis are important for early assessment of biomechanics. ACL injury is an ideal clinical model for studying knee osteoarthritis.

To clarify the mechanism between the biomechanical status of knee joint and the change of gait touch information, and to provide scientific basis for quantifying and evaluating the biomechanical status of knee joint in dynamic load-bearing state.

详细描述

Purpose: To clarify the relationship between the normal and abnormal biomechanical status of the knee joint and the gait touch information, and to establish the biomechanical evaluation model of the knee joint during walking or jogging, taking into account the comprehensive effects of sports parameters, individual attribute parameters and other factors. An automatic analysis and expert diagnosis system was established to evaluate the biomechanics of knee joint.

Methods: 50 young male (23-35 years old) healthy volunteers and 100 patients with unilateral simple ACL rupture who need surgical treatment were recruited, 150 subjects in total. Three tests were performed before surgery, at the end of the 24th and 48th weeks after surgery. All were tested with three-dimensional gait analysis, dynamic plantar pressure measurement and isokinetic muscle strength during walking, jogging, emergency stop and take-off, side cut.

Outcome evaluation indicators and statistical methods: Two-way ANOVA method of repeated measurement was used, the left and right sides and different rehabilitation time were used as the variables of repeated measurement: the biomechanics of the lower limb joint and the change of the biological characteristics of the gait touch information were analyzed. Three dimensional gait analysis and computer-aided analysis of gait touch information were used to study the changes of ACL rupture and reconstruction. Based on the information of gait touch, taking into account the comprehensive effects of sports parameters, individual attribute parameters and other factors, a biomechanical evaluation model of knee joint during walking or jogging is established, which provides the exact basis for quantifying the information of gait touch and evaluating the biomechanical state of knee joint after ACL rupture and reconstruction under dynamic load-bearing state, and establishes a clinical practical automatic analysis and expert diagnosis system of gait touch information to evaluate the biomechanics of the knee joint.

研究设计

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

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 18-35 years old
  • Patients who have isolated ACL injury and receive ACL reconstruction surgery at Peking University Third Hospital.
  • With isolated ACL injury (an ACL injury with no need for surgical repairs to other knee structures).
  • All participants have no known disorders or diseases other than ACL rupture.

排除标准

  • Female patients who are pregnant, or suspected pregnant, or in breastfeeding will be excluded from this study.

结局指标

主要结局

walking speed

时间窗: at 48th weeks after Anterior Cruciate Ligament reconstruction.

Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.

ground reaction force

时间窗: at 48th weeks after Anterior Cruciate Ligament reconstruction.

Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.

knee flexion angle

时间窗: at 48th weeks after Anterior Cruciate Ligament reconstruction.

Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.

the moment of knee extension in the gait cycle

时间窗: at 48th weeks after Anterior Cruciate Ligament reconstruction.

Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.

the moment of knee flexion in the gait cycle

时间窗: at 48th weeks after Anterior Cruciate Ligament reconstruction.

Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.

次要结局

  • The International Knee Documentation Committee (IKDC) score(On the day of enrollment, at 24th and 48th weeks after Anterior Cruciate Ligament reconstruction.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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