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

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04715672
Collaborator
(none)
50
1
24
2.1

Study Details

Study Description

Brief Summary

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 Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
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
Actual Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
copper

no-copper

normal

Outcome Measures

Primary Outcome Measures

  1. ALFF [2 years post-operation]

    ALFF algorithm to calculate BLOD signals in the subfrequency band of resting state functional magnetic resonance imaging (fMRI)

  2. FC [2 years post-operation]

    functional connection between brain region of interest in the subfrequency band of resting state magnetic resonance imaging (fMRI)

Secondary Outcome Measures

  1. Lysholm [2 years post-operation]

    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. Tegner [2 years post-operation]

    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.

  3. COP(center of pressure ) [2 years post-operation]

    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

  4. CR [2 years post-operation]

    Hamstring Co-contraction ratio(CR) in the Single foot support phase by using the Surface electromyography when patients are walking and running.

  5. single leg jump test [2 years post-operation]

    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

  6. 6M timing single leg jump test [2 years post-operation]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hongyun song Hangzhou Zhejiang China

Sponsors and Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT04715672
Other Study ID Numbers:
  • 2020-144
First Posted:
Jan 20, 2021
Last Update Posted:
Jan 20, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 20, 2021