Bilateral Knee Osteoarthritis Clinical Trial
| Verified date | February 2014 |
| Source | University of Malaya |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Malaysia: Institutional Review Board |
| Study type | Interventional |
Treatment: five intro-articular Hyaluronic Acid injection
Assessment has two parts, that are as follow:
1. Postural stability and risk of fall assessment using Biodex stability index and "Timed
up and Go" test
2. 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.
| Status | Completed |
| Enrollment | 85 |
| Est. completion date | |
| Est. primary completion date | October 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 50 Years to 70 Years |
| Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| University of Malaya |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in Postural stability after treatment | baseline and 6 weeks | No | |
| Primary | Changes in Biomechanics of gait after treatment | baseline and 6 weeks | No | |
| Primary | Changes in biomechanics of stair climbing after treatment | baseline and 6 weeks | No | |
| Secondary | Change in Pain after treatment | baseline and 6 weeks | No | |
| Secondary | Changes in WOMAC scores after treatment | baseline and 6 weeks | No |
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