Trials / Completed
CompletedNCT03684850
Knee Brace and Biomechanical Footwear in the Treatment of Knee Osteoarthritis.
Effect of Unloader Knee Brace and Biomechanical Footwear Device on Symptoms and Physical Function in Knee Osteoarthritis Patients - a Randomized Controlled Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (actual)
- Sponsor
- Central Finland Hospital District · Academic / Other
- Sex
- All
- Age
- 45 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This study investigates the effects of unloader knee brace, biomechanical footwear device and exercise therapy on pain, physical function and quality of life in patients with knee osteoarthritis. The aim is to find more effective treatment strategies to delay or prevent heavy knee replacement surgeries.
Detailed description
The aim of this study is to investigate the effects of exercising, and using a knee brace and exercising, and using of biomechanical footwear device on clinically important symptoms, physical function and quality of life in patients with osteoarthritis of the knee. The hypothesis is that the groups of using knee brace and biomechanical footwear can alleviate pain, improve physical function and quality of life more efficiently, than the group doing home exercises only. The subjects (n = 120) will be randomized into three groups mentioned above, after which they will start to do exercises, or to use a knee brace and do exercises, or to use biomechanical footwear at home according to the instructions for 4 months. Physical function, symptoms and quality of life will be measured before and after 4-month intervention. In addition, at 12-month time point follow-up surveys will be addressed with regard to symptoms and quality of life, as well as to cost-effectiveness of the study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Home-based exercise | Home-based exercises three times per week. |
| DEVICE | Knee brace | Progressive use of knee brace each day during activities of daily living. |
| DEVICE | Biomechanical footwear device | Progressive use of footwear each day during activities of daily living. |
Timeline
- Start date
- 2016-12-01
- Primary completion
- 2019-10-01
- Completion
- 2019-10-01
- First posted
- 2018-09-26
- Last updated
- 2020-01-31
Locations
1 site across 1 country: Finland
Source: ClinicalTrials.gov record NCT03684850. Inclusion in this directory is not an endorsement.