- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT03130400
Kinematic Parameters to Predict Knee Diseases.
17. května 2017 aktualizováno: Yu Zhang, Guangzhou General Hospital of Guangzhou Military Command
Can Gait Parameters Predict Knee Injuries/Arthritis?
There is no study to explore the prediction of knee diseases using kinematic parameters of knee during gait.
The aim of this study is to explore the possibility of predicting knee diseases by gait parameters.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Typ studie
Pozorovací
Zápis (Aktuální)
1914
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
-
Guangdong
-
Guangzhou, Guangdong, Čína, 510010
- Hospital of Orthopedics, Guangzhou General Hospital of Guangzhou Military Command
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 90 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Všechno
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
All the patients were from January 2013 to March 2017.
Popis
Inclusion Criteria:
- age> 18 years
- body mass index<30;
- confirmed radiographically or by surgery to have knee injuries/arthritis;
- knee pain in their knees at least one months;
- able to walk unaided
Exclusion Criteria:
- history of other lower limbs' surgery/injuries/arthritis (hip or ankle);
- Corticosteroid or Sodium Hyaluronate injection within 6 months;
- neuropathic arthropathy or rheumatoid arthritis;
- any other muscular or neurological diseases that affected the condition of the lower limbs;
- unable to walk independently;
- history of heart disease;
- body mass index> 30;
- age> 90 years;
- unable to finish the procedure
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
Normal
This group is control group.
Participants in this group do not have knee diseases or any other bad injuries in lower limbs.
|
All the participants underwent a standard observational procedure: i) diagnosed with knee injuries/arthritis; ii) For KOA, take radiographic examination (x-ray) and take gait analysis on a treadmill in barefoot; iii) For knee injuries, take gait analysis before surgery, the disease of patients was confirmed by surgery (knee arthroscopy); iv)Normal people take an physical examination to avoid other disease;
|
|
KOA
Participants in this group have knee osteoarthritis and have no other bad injuries in lower limbs.
|
All the participants underwent a standard observational procedure: i) diagnosed with knee injuries/arthritis; ii) For KOA, take radiographic examination (x-ray) and take gait analysis on a treadmill in barefoot; iii) For knee injuries, take gait analysis before surgery, the disease of patients was confirmed by surgery (knee arthroscopy); iv)Normal people take an physical examination to avoid other disease;
|
|
ACLD
Participants in this group have anterior cruciate ligament deficiency with or without meniscus deficiency and have no other bad injuries in lower limbs.
|
All the participants underwent a standard observational procedure: i) diagnosed with knee injuries/arthritis; ii) For KOA, take radiographic examination (x-ray) and take gait analysis on a treadmill in barefoot; iii) For knee injuries, take gait analysis before surgery, the disease of patients was confirmed by surgery (knee arthroscopy); iv)Normal people take an physical examination to avoid other disease;
|
|
MD
Participants in this group have meniscus deficiency and have no other bad injuries in lower limbs.
|
All the participants underwent a standard observational procedure: i) diagnosed with knee injuries/arthritis; ii) For KOA, take radiographic examination (x-ray) and take gait analysis on a treadmill in barefoot; iii) For knee injuries, take gait analysis before surgery, the disease of patients was confirmed by surgery (knee arthroscopy); iv)Normal people take an physical examination to avoid other disease;
|
|
Plica
Participants in this group have plica syndrome and have no other bad injuries in lower limbs.
|
All the participants underwent a standard observational procedure: i) diagnosed with knee injuries/arthritis; ii) For KOA, take radiographic examination (x-ray) and take gait analysis on a treadmill in barefoot; iii) For knee injuries, take gait analysis before surgery, the disease of patients was confirmed by surgery (knee arthroscopy); iv)Normal people take an physical examination to avoid other disease;
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Knee flexion/extension angle at initial contact during gait.
Časové okno: About 15 min
|
The gait cycle include seven key events (e.g.
initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation.
The unit of angle is degree and that of translation is millimetre.
|
About 15 min
|
|
Knee internal/external rotation angle at initial contact during gait.
Časové okno: About 15 min
|
The gait cycle include seven key events (e.g.
initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation.
The unit of angle is degree and that of translation is millimetre.
|
About 15 min
|
|
Knee adduction/abduction angle at initial contact during gait.
Časové okno: About 15 min
|
The gait cycle include seven key events (e.g.
initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation.
The unit of angle is degree and that of translation is millimetre.
|
About 15 min
|
|
knee anterior/posterior translation at initial contact during gait.
Časové okno: About 15 min
|
The gait cycle include seven key events (e.g.
initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation.
The unit of angle is degree and that of translation is millimetre.
|
About 15 min
|
|
Knee medial/lateral translation at initial contact during gait.
Časové okno: About 15 min
|
The gait cycle include seven key events (e.g.
initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation.
The unit of angle is degree and that of translation is millimetre.
|
About 15 min
|
|
Knee proximal/distal translation at initial contact during gait.
Časové okno: About 15 min
|
The gait cycle include seven key events (e.g.
initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation.
The unit of angle is degree and that of translation is millimetre.
|
About 15 min
|
|
Knee flexion/extension angle at opposite toe off during gait.
Časové okno: About 15 min
|
The gait cycle include seven key events (e.g.
initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation.
The unit of angle is degree and that of translation is millimetre.
|
About 15 min
|
|
Knee internal/external rotation angle at opposite toe off during gait.
Časové okno: About 15 min
|
The gait cycle include seven key events (e.g.
initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation.
The unit of angle is degree and that of translation is millimetre.
|
About 15 min
|
|
Knee adduction/abduction angle at opposite toe off during gait.
Časové okno: About 15 min
|
The gait cycle include seven key events (e.g.
initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation.
The unit of angle is degree and that of translation is millimetre.
|
About 15 min
|
|
Knee anterior/posterior translation at opposite toe off during gait.
Časové okno: About 15 min
|
The gait cycle include seven key events (e.g.
initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation.
The unit of angle is degree and that of translation is millimetre.
|
About 15 min
|
|
Knee distal/proximal translation at opposite toe off during gait.
Časové okno: About 15 min
|
The gait cycle include seven key events (e.g.
initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation.
The unit of angle is degree and that of translation is millimetre.
|
About 15 min
|
|
Knee medial/lateral translation at opposite toe off during gait.
Časové okno: About 15 min
|
The gait cycle include seven key events (e.g.
initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation.
The unit of angle is degree and that of translation is millimetre.
|
About 15 min
|
|
Knee flexion/extension angle at heel rise during gait.
Časové okno: About 15 min
|
The gait cycle include seven key events (e.g.
initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation.
The unit of angle is degree and that of translation is millimetre.
|
About 15 min
|
|
Knee internal/external rotation angle at heel rise during gait.
Časové okno: About 15 min
|
The gait cycle include seven key events (e.g.
initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation.
The unit of angle is degree and that of translation is millimetre.
|
About 15 min
|
|
Knee adduction/abduction angle at heel rise during gait.
Časové okno: About 15 min
|
The gait cycle include seven key events (e.g.
initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation.
The unit of angle is degree and that of translation is millimetre.
|
About 15 min
|
|
Knee anterior/posterior translation at heel rise during gait.
Časové okno: About 15 min
|
The gait cycle include seven key events (e.g.
initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation.
The unit of angle is degree and that of translation is millimetre.
|
About 15 min
|
|
Knee distal/proximal translation at heel rise during gait.
Časové okno: About 15 min
|
The gait cycle include seven key events (e.g.
initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation.
The unit of angle is degree and that of translation is millimetre.
|
About 15 min
|
|
Knee medial/lateral translation at heel rise during gait.
Časové okno: About 15 min
|
The gait cycle include seven key events (e.g.
initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation.
The unit of angle is degree and that of translation is millimetre.
|
About 15 min
|
|
Knee flexion/extension angle at opposite initial contact during gait.
Časové okno: About 15 min
|
The gait cycle include seven key events (e.g.
initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation.
The unit of angle is degree and that of translation is millimetre.
|
About 15 min
|
|
Knee internal/external angle at opposite initial contact during gait.
Časové okno: About 15 min
|
The gait cycle include seven key events (e.g.
initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation.
The unit of angle is degree and that of translation is millimetre.
|
About 15 min
|
|
Knee adduction/abduction angle at opposite initial contact during gait.
Časové okno: About 15 min
|
The gait cycle include seven key events (e.g.
initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation.
The unit of angle is degree and that of translation is millimetre.
|
About 15 min
|
|
Knee anterior/posterior translation at opposite initial contact during gait.
Časové okno: About 15 min
|
The gait cycle include seven key events (e.g.
initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation.
The unit of angle is degree and that of translation is millimetre.
|
About 15 min
|
|
Knee distal/proximal translation at opposite initial contact during gait.
Časové okno: About 15 min
|
The gait cycle include seven key events (e.g.
initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation.
The unit of angle is degree and that of translation is millimetre.
|
About 15 min
|
|
Knee medial/lateral translation at opposite initial contact during gait.
Časové okno: About 15 min
|
The gait cycle include seven key events (e.g.
initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation.
The unit of angle is degree and that of translation is millimetre.
|
About 15 min
|
|
Knee flexion/extension angle at toe off during gait.
Časové okno: About 15 min
|
The gait cycle include seven key events (e.g.
initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation.
The unit of angle is degree and that of translation is millimetre.
|
About 15 min
|
|
Knee adduction/abduction angle at toe off during gait.
Časové okno: About 15 min
|
The gait cycle include seven key events (e.g.
initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation.
The unit of angle is degree and that of translation is millimetre.
|
About 15 min
|
|
Knee internal/external rotation angle at toe off during gait.
Časové okno: About 15 min
|
The same as the first primary outcome measure.
|
About 15 min
|
|
Knee anterior/posterior translation at toe off during gait.
Časové okno: About 15 min
|
The gait cycle include seven key events (e.g.
initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation.
The unit of angle is degree and that of translation is millimetre.
|
About 15 min
|
|
Knee distal/proximal translation at toe off during gait.
Časové okno: About 15 min
|
The gait cycle include seven key events (e.g.
initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation.
The unit of angle is degree and that of translation is millimetre.
|
About 15 min
|
|
Knee medial/lateral translation at toe off during gait
Časové okno: About 15 min
|
The gait cycle include seven key events (e.g.
initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation.
The unit of angle is degree and that of translation is millimetre.
|
About 15 min
|
|
Knee flexion/extension angle at feet adjacent during gait.
Časové okno: About 15 min
|
The gait cycle include seven key events (e.g.
initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation.
The unit of angle is degree and that of translation is millimetre.
|
About 15 min
|
|
Knee internal/external rotation angle at feet adjacent during gait.
Časové okno: About 15 min
|
The gait cycle include seven key events (e.g.
initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation.
The unit of angle is degree and that of translation is millimetre.
|
About 15 min
|
|
Knee adduction/abduction angle at feet adjacent during gait.
Časové okno: About 15 min
|
The gait cycle include seven key events (e.g.
initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation.
The unit of angle is degree and that of translation is millimetre.
|
About 15 min
|
|
Knee anterior/posterior translation at feet adjacent during gait.
Časové okno: About 15 min
|
The same as the first primary outcome measure.
|
About 15 min
|
|
Knee distal/proximal translation at feet adjacent during gait.
Časové okno: About 15 min
|
The gait cycle include seven key events (e.g.
initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation.
The unit of angle is degree and that of translation is millimetre.
|
About 15 min
|
|
Knee medial/lateral translation at feet adjacent during gait.
Časové okno: About 15 min
|
The gait cycle include seven key events (e.g.
initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation.
The unit of angle is degree and that of translation is millimetre.
|
About 15 min
|
|
Knee flexion/extension angle at tibia vertical during gait.
Časové okno: About 15 min
|
The gait cycle include seven key events (e.g.
initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation.
The unit of angle is degree and that of translation is millimetre.
|
About 15 min
|
|
Knee adduction/abduction angle at tibia vertical during gait.
Časové okno: About 15 min
|
The gait cycle include seven key events (e.g.
initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation.
The unit of angle is degree and that of translation is millimetre.
|
About 15 min
|
|
Knee internal/external rotation angle at tibia vertical during gait.
Časové okno: About 15 min
|
The gait cycle include seven key events (e.g.
initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation.
The unit of angle is degree and that of translation is millimetre.
|
About 15 min
|
|
Knee anterior/posterior translation at tibia vertical during gait.
Časové okno: About 15 min
|
The gait cycle include seven key events (e.g.
initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation.
The unit of angle is degree and that of translation is millimetre.
|
About 15 min
|
|
Knee distal/proximal translation at tibia vertical during gait.
Časové okno: About 15 min
|
The gait cycle include seven key events (e.g.
initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation.
The unit of angle is degree and that of translation is millimetre.
|
About 15 min
|
|
Knee medial/lateral translation at tibia vertical during gait.
Časové okno: About 15 min
|
The gait cycle include seven key events (e.g.
initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation.
The unit of angle is degree and that of translation is millimetre.
|
About 15 min
|
|
Range of motion of knee flexion/extension angle.
Časové okno: About 15 min
|
The gait cycle include seven key events (e.g.
initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation.
The unit of angle is degree and that of translation is millimetre.
|
About 15 min
|
|
Range of motion of knee internal/external rotation angle.
Časové okno: About 15 min
|
The gait cycle include seven key events (e.g.
initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation.
The unit of angle is degree and that of translation is millimetre.
|
About 15 min
|
|
Range of motion of knee adduction/abduction angle.
Časové okno: About 15 min
|
The gait cycle include seven key events (e.g.
initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation.
The unit of angle is degree and that of translation is millimetre.
|
About 15 min
|
|
Range of motion of knee anterior/posterior translation.
Časové okno: About 15 min
|
The gait cycle include seven key events (e.g.
initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation.
The unit of angle is degree and that of translation is millimetre.
|
About 15 min
|
|
Range of motion of knee distal/proximal translation.
Časové okno: About 15 min
|
The gait cycle include seven key events (e.g.
initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation.
The unit of angle is degree and that of translation is millimetre.
|
About 15 min
|
|
Range of motion of knee medial/lateral translation.
Časové okno: About 15 min
|
The gait cycle include seven key events (e.g.
initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation.
The unit of angle is degree and that of translation is millimetre.
|
About 15 min
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
20. dubna 2017
Primární dokončení (Aktuální)
14. května 2017
Dokončení studie (Aktuální)
17. května 2017
Termíny zápisu do studia
První předloženo
23. dubna 2017
První předloženo, které splnilo kritéria kontroly kvality
25. dubna 2017
První zveřejněno (Aktuální)
26. dubna 2017
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
18. května 2017
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
17. května 2017
Naposledy ověřeno
1. května 2017
Více informací
Termíny související s touto studií
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Klinické studie na Observational gait analysis procedure
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Burcin CelikOndokuz Mayıs UniversityZatím nenabírámeChronická obstrukční plicní nemoc (CHOPN)