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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04715672
Enrollment
50
Registered
2021-01-20
Start date
2021-01-01
Completion date
2022-12-31
Last updated
2021-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Reconstruction;Resting State Functional Magnetic Resonance;Three-dimensional Gait Analysis;Return to Sports

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.

Interventions

None listed

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to 50 Years
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

Design outcomes

Primary

MeasureTime frameDescription
ALFF2 years post-operationALFF algorithm to calculate BLOD signals in the subfrequency band of resting state functional magnetic resonance imaging (fMRI)
FC2 years post-operationfunctional connection between brain region of interest in the subfrequency band of resting state magnetic resonance imaging (fMRI)

Secondary

MeasureTime frameDescription
COP(center of pressure )2 years post-operationsymmetry 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
CR2 years post-operationHamstring Co-contraction ratio(CR) in the Single foot support phase by using the Surface electromyography when patients are walking and running.
Lysholm2 years post-operationLysholm 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
6M timing single leg jump test2 years post-operationThe 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
single leg jump test2 years post-operationPatient 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
Tegner2 years post-operationTegner 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026