Gait, Stair Climbing and Postural Stability in Knee Osteoarthritis Patients After Hyaluronic Acid Injection
February 12, 2014 updated by: nafiseh khalaj, University of Malaya
Treatment: five intro-articular Hyaluronic Acid injection
Assessment has two parts, that are as follow:
- Postural stability and risk of fall assessment using Biodex stability index and "Timed up and Go" test
- Gait and stair climbing assessment using Vicon motion capture system synchronized with four force plates.
For knee OA subjects, assessment was done in week one or before injection; and for healthy controls one assessment was performed.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study aimed to assess the effect of hyaluronic acid injection on Postural stability, biomechanics of gait and stair climbing in individuals with bilateral knee osteoarthritis (OA).
Participants were individuals with knee OA (control and treatment) and healthy people.
Study Type
Interventional
Enrollment (Actual)
85
Phase
- Phase 3
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
50 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Mild and moderate bilateral knee osteoarthritis
- Age between 50 and 70 years
Exclusion Criteria:
- Recent Lower limb injury
- Diabetic
- Knee or hip replacement
- Knees HA injection in last 6 months
- Any neuromuscular disease such as stroke and Parkinson
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
- Primary Purpose: BASIC_SCIENCE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: biomechanis knee OA and HA injection
Weekly intra- articular Hyaluronic acid injection (20 MG/ 2 ML) into both knees for five weeks
|
treatment: Weekly intra-articular hyaluronic acid injection (20 MG / 2ML) into both knees for five weeks.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in Postural stability after treatment
Time Frame: baseline and 6 weeks
|
baseline and 6 weeks
|
|
Changes in Biomechanics of gait after treatment
Time Frame: baseline and 6 weeks
|
baseline and 6 weeks
|
|
Changes in biomechanics of stair climbing after treatment
Time Frame: baseline and 6 weeks
|
baseline and 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in Pain after treatment
Time Frame: baseline and 6 weeks
|
baseline and 6 weeks
|
|
Changes in WOMAC scores after treatment
Time Frame: baseline and 6 weeks
|
baseline and 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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
September 1, 2012
Primary Completion (ACTUAL)
October 1, 2013
Study Registration Dates
First Submitted
February 11, 2014
First Submitted That Met QC Criteria
February 12, 2014
First Posted (ESTIMATE)
February 14, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
February 14, 2014
Last Update Submitted That Met QC Criteria
February 12, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UM/MOHE/HIR D000010-16001
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.