- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03130400
Kinematic Parameters to Predict Knee Diseases.
17 mai 2017 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Observationnel
Inscription (Réel)
1914
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Guangdong
-
Guangzhou, Guangdong, Chine, 510010
- Hospital of Orthopedics, Guangzhou General Hospital of Guangzhou Military Command
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 90 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
All the patients were from January 2013 to March 2017.
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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;
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Knee flexion/extension angle at initial contact during gait.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: About 15 min
|
The same as the first primary outcome measure.
|
About 15 min
|
|
Knee anterior/posterior translation at toe off during gait.
Délai: 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.
Délai: 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
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: About 15 min
|
The same as the first primary outcome measure.
|
About 15 min
|
|
Knee distal/proximal translation at feet adjacent during gait.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
20 avril 2017
Achèvement primaire (Réel)
14 mai 2017
Achèvement de l'étude (Réel)
17 mai 2017
Dates d'inscription aux études
Première soumission
23 avril 2017
Première soumission répondant aux critères de contrôle qualité
25 avril 2017
Première publication (Réel)
26 avril 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
18 mai 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
17 mai 2017
Dernière vérification
1 mai 2017
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- GuangzhouGH007
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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