- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02063373
Gait, Stair Climbing and Postural Stability in Knee Osteoarthritis Patients After Hyaluronic Acid Injection
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
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
Enrollment (Actual)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
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.
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