- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03130400
Kinematic Parameters to Predict Knee Diseases.
May 17, 2017 updated by: 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
1914
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510010
- Hospital of Orthopedics, Guangzhou General Hospital of Guangzhou Military Command
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All the patients were from January 2013 to March 2017.
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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;
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knee flexion/extension angle at initial contact during gait.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: About 15 min
|
The same as the first primary outcome measure.
|
About 15 min
|
|
Knee anterior/posterior translation at toe off during gait.
Time Frame: 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.
Time Frame: 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
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: About 15 min
|
The same as the first primary outcome measure.
|
About 15 min
|
|
Knee distal/proximal translation at feet adjacent during gait.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 20, 2017
Primary Completion (Actual)
May 14, 2017
Study Completion (Actual)
May 17, 2017
Study Registration Dates
First Submitted
April 23, 2017
First Submitted That Met QC Criteria
April 25, 2017
First Posted (Actual)
April 26, 2017
Study Record Updates
Last Update Posted (Actual)
May 18, 2017
Last Update Submitted That Met QC Criteria
May 17, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GuangzhouGH007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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