- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04715672
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
Studieoversigt
Status
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
-
-
Zhejiang
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Hangzhou, Zhejiang, Kina
- Rekruttering
- Hongyun song
-
Kontakt:
- Hongyun Song, master
- Telefonnummer: +86 0571-87783684
- E-mail: hedy.song@zju.edu.cn
-
Ledende efterforsker:
- Hongyun Song, master
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
normal
|
|
copper
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no-copper
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
ALFF
Tidsramme: 2 years post-operation
|
ALFF algorithm to calculate BLOD signals in the subfrequency band of resting state functional magnetic resonance imaging (fMRI)
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2 years post-operation
|
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FC
Tidsramme: 2 years post-operation
|
functional connection between brain region of interest in the subfrequency band of resting state magnetic resonance imaging (fMRI)
|
2 years post-operation
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Lysholm
Tidsramme: 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 years post-operation
|
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Tegner
Tidsramme: 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.
|
2 years post-operation
|
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COP(center of pressure )
Tidsramme: 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
|
2 years post-operation
|
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CR
Tidsramme: 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.
|
2 years post-operation
|
|
single leg jump test
Tidsramme: 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
|
2 years post-operation
|
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6M timing single leg jump test
Tidsramme: 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
|
2 years post-operation
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2020-144
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-deling Understøttende informationstype
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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