Biomechanical Mechanism of the Change of the Gait Touch Information After ACL Rupture

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.

Study Overview

• Status: Unknown
• Conditions: Anterior Cruciate Ligament Injuries
• Intervention / Treatment: Other: no intervention

Detailed Description

The purpose of this study is to identify the characteristics of the disease, diagnose the disease by computer and evaluate the rehabilitation based on gait touch information after ACL rupture and reconstruction, combined with the methods of multi-body dynamics, machine learning and biomechanics analysis. Methods: 55 healthy volunteers, 55 patients with ACL rupture were recruited. Three dimensional gait analysis and dynamic plantar pressure were used to test the kinematic and dynamic data of lower limbs and gait touch information when walking, jogging, stopping and jumping, and running side cutting.

Outcome evaluation indexes and statistical methods:

the following indexes were measured repeatedly by two factor ANOVA method, and 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 gait touch information were analyzed. To study the biomechanical status of different knee joints and the mechanism of the change of gait touch information. Finally, based on the information of gait touch, a biomechanical evaluation model of knee joint during walking or jogging is established, which provides the exact basis for quantifying and evaluating the biomechanical state of knee joint under the dynamic load-bearing state of gait touch information.

• Study Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100191
    • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Inclusion criteria: Age: 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.

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Cognitive impairment
• Other injuries affecting movement performance.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
normal control group; According to the previous clinical diagnosis, volunteers who has never suffered the lower extremity sports injuries.	Other: no intervention; This is an observation study, with no intervention
Anterior Cruciate Ligament injury and reconstruction group; According to the previous clinical diagnosis, patients who has suffered the Anterior Cruciate Ligament injury.	Other: no intervention; This is an observation study, with no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
walking speed	Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.	On the day of enrollment.
ground reaction force	Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.	On the day of enrollment.
knee flexion angle	Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.	On the day of enrollment.
the moment of knee extension in the gait cycle	Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.	On the day of enrollment.
the moment of knee flexion in the gait cycle	Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.	On the day of enrollment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The International Knee Documentation Committee (IKDC) score	The International Knee Documentation Committee (IKDC) score was used to evaluate the knee health.The patients completed score by themselves. The lowest score is 0 and the highest score is 100. The higher is better.	On the day of enrollment.

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 2, 2017
• Primary Completion (ACTUAL): January 8, 2020
• Study Completion (ANTICIPATED): December 30, 2020

Study Registration Dates

• First Submitted: June 29, 2020
• First Submitted That Met QC Criteria: July 6, 2020
• First Posted (ACTUAL): July 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 9, 2020
• Last Update Submitted That Met QC Criteria: July 6, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: gait analysis; plantar pressure; anterior cruciate ligament; multi-body dynamics modeling
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Rupture; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: OR004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No