The Establishment of Advanced Brain Function Evaluation Model for Anterior Cruciate Ligament Reconstruction

The Establishment of Evaluation Model About Returning to Sports Post-operation of Anterior Cruciate Ligament Reconstruction by Resting State Functional Magnetic Resonance and Three-dimensional Gait Analysis

It is difficult to establish the standard of return to sports post anterior cruciate ligament (ACL) reconstruction. The amplitude of low frequency fluctuation (ALFF) and functional connectivity (FC) of resting state functional magnetic resonance imaging (fMRI) can explore the differences in neural function of different populations, but have not been applied in the study of ACL postoperative return to sports.This project intends to use ALFF algorithm to calculate the changes of BLOD signals of coppers and non- coppers after ACL surgery in the subfrequency band and the functional network in the subfrequency band, explore the relationship between the default network (DMN) and the sensorimotor network (SMN), and use three-dimensional gait analysis to carry out accurate functional test..This project will explore the central strategy of ACL postoperative functional recovery from a new perspective, to provide a more reasonable high-level evaluation index for the timing of return to sports, and to reduce the incidence of postoperative re-tearing.

Study Overview

• Status: Unknown
• Conditions: Anterior Cruciate Ligament Reconstruction;Resting State Functional Magnetic Resonance;Three-dimensional Gait Analysis;Return to Sports

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Hongyun song
      • Contact: Hongyun Song, master; Phone Number: +86 0571-87783684; Email: hedy.song@zju.edu.cn
      • Principal Investigator: Hongyun Song, master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients post anteriorcruciate ligament (ACL) reconstruction

Description

Inclusion Criteria:

Patients who completed the same operation and completed phased home rehabilitation instruction and who underwent ACL reconstruction more than 2 years after the operation were recruited as the test subjects

Exclusion Criteria:

heart and nervous system diseases, Other sports injuries such as medial collateral ligament injury, meniscus repair, grade III-IV cartilage injury, ankle instability, metal implants in the body and medication were excluded

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
normal
copper
no-copper

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ALFF	ALFF algorithm to calculate BLOD signals in the subfrequency band of resting state functional magnetic resonance imaging (fMRI)	2 years post-operation
FC	functional connection between brain region of interest in the subfrequency band of resting state magnetic resonance imaging (fMRI)	2 years post-operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lysholm	Lysholm scale, which is used to measure the functional status of a patient's knee joint has a minimum value of 0 and a maximum value of 100, with the higher the score, the better the function	2 years post-operation
Tegner	Tegner scale，which is used to measure the functional status of patients has a minimum value of 0 and a maximum value of 10, with the higher the score, the better of the function.	2 years post-operation
COP（center of pressure ）	symmetry of center of pressure transfer path by using Plantar pressure testing system when patients are walking and running. limb symmetry index =injury limb score/good limb score *100	2 years post-operation
CR	Hamstring Co-contraction ratio(CR) in the Single foot support phase by using the Surface electromyography when patients are walking and running.	2 years post-operation
single leg jump test	Patient stands onhis or her leg , toe on starting line, try to jump forward and land on ipsilateral limb, measure the distance between starting line and patient's feet. limb symmetry index =injury limb score/good limb score *100	2 years post-operation
6M timing single leg jump test	The patient stood on his or her leg, with the toes on the starting line. After the tester gave the command of "each in position, prepare, run", the chronograph was accurate to 0.01 seconds to start the time. The patient's healthy limbs jump as soon as possible and stop the timing when reaching the 6m terminal.limb symmetry index =injury limb score/good limb score *100	2 years post-operation

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: January 13, 2021
• First Submitted That Met QC Criteria: January 18, 2021
• First Posted (Actual): January 20, 2021

Study Record Updates

• Last Update Posted (Actual): January 20, 2021
• Last Update Submitted That Met QC Criteria: January 18, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2020-144

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

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