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

Anterior Cruciate Ligament Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04464330
• Other study ID #: OR004
• Status: Active, not recruiting
• Start date: April 2, 2017
• Est. completion date: December 30, 2020

Study information

• Verified date: June 2020
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: December 30, 2020
• Est. primary completion date: January 8, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Rupture

Intervention

Other:
• no intervention
This is an observation study, with no intervention

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	walking speed	Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.	On the day of enrollment.
Primary	ground reaction force	Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.	On the day of enrollment.
Primary	knee flexion angle	Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.	On the day of enrollment.
Primary	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.
Primary	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	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.