Clinical trial NCT04464330: Biomechanical Mechanism of the Change of the Gait Touch Information After ACL Rupture
Official title: Biomechanical Mechanism of the Change of the Gait Touch Information After ACL Rupture
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anterior Cruciate Ligament Injuries
Keywords: anterior cruciate ligament
gait analysis
plantar pressure
multi-body dynamics modeling
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: walking speed
timeFrame: On the day of enrollment.
measure: ground reaction force
timeFrame: On the day of enrollment.
measure: knee flexion angle
timeFrame: On the day of enrollment.
measure: the moment of knee extension in the gait cycle
timeFrame: On the day of enrollment.
measure: the moment of knee flexion in the gait cycle
timeFrame: On the day of enrollment.
Secondary outcomes:
measure: The International Knee Documentation Committee (IKDC) score
timeFrame: On the day of enrollment.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Peking University Third Hospital
name: Hongshi Huang, Doctor
role: STUDY_CHAIR
References: