Central Finland Central Hospital
Jyväskylä, 40700, Finland
NCT Number: NCT03684850
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.
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Notify Me45 year–70 year
All sexes
Interventional
Not applicable
Jyväskylä, 40700, Finland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Home-based exercises three times per week.
Progressive use of knee brace each day during activities of daily living.
Progressive use of footwear each day during activities of daily living.
Time frame: 4 months
Visual Analog Scale for Pain (score of 100 mm). No pain (score of 0), worst imaginable pain (score of 100).
Time frame: 4 months
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)-questionnaire evaluates the condition of patients with knee osteoarthritis including pain, stiffness and physical function. In the subscale of pain (score range 0 - 500), stiffness (score range 0 - 200), and functional limitation (score range 0 - 1700) lower values represent a better outcome. In order to normalize each score on 0 - 100 scales, the following correction factors are used: pain 0.20, stiffness 0.50, functional limitation 0.059.
Time frame: 4 months
The SF-36-Item Health Survey measures Health-Related Quality of Life. The SF-36 is a multi-item scale assessing eight health concepts: 1) limitations in physical activities, 2) limitations in social activities, 3) limitations in usual role activities, 4) bodily pain, 5) general mental health, 6) limitations in usual role activities, 7) vitality, and 8) general health perceptions, with scores for each dimensions ranging from 0 (poor health) to 100 (good health).
Time frame: 4 months
Will be measured with dynamometer
Time frame: 4 months
Walking speed (cm/sec) will be measured by the instrumented walkway system (GAITRite mat).
Time frame: 4 months
Cadence (steps per minute) will be measured by the instrumented walkway system (GAITRite mat).
Time frame: 4 months
Stride length, i.e., the distance between 2 successive placement of the same foot (cm) will be measured by the instrumented walkway system (GAITRite mat).
Time frame: 4 months
Step length, i.e., the distance measured from the heel point of one foot to the heel point of the other foot (cm) will be measured by the instrumented walkway system (GAITRite mat).
Time frame: 4 months
Stance time (sec) and % stance will be measured by the instrumented walkway system (GAITRite mat).
Time frame: 4 months
Swing time (sec) and % swing will be measured by the instrumented walkway system (GAITRite mat).
Time frame: 4 months
A fast-paced walking test that is timed over 4 x 10m for a total 40 m
Time frame: 4 months
The time (sec) it takes to ascend and descend a flight of stairs. The total time to ascend and descend steps (negative number indicates better performance) will be recorded and reported
Time frame: 4 months
The maximum number of chair stand repetitions possible in a 30 second period. The total number of chair stands (up and down equals one stand) completed in 30 seconds will be reported.
Time frame: 4 months
Will be measured with goniometer
Time frame: 4 months
The short form of International Physical Activity (IPAQ-SF) questionnaire measures data on Health-Related Physical Activity. The IPAQ-SF Records the activity of four intensity levels (vigorous-intensity, moderate-intensity, walking, sitting) for the last 7 days. Results are reported as a continuous variable (MET minutes a week). To calculate MET minutes a week the MET value given (walking = 3.3, moderate activity = 4, vigorous activity = 8) is multiplied by the minutes the activity was carried out and again by the number of days that the activity was undertaken. To get total MET minutes of physical activity a week, the MET minutes achieved in each category are added together. Higher MET-values represent better outcome.
Time frame: 4 months
Will be measured with the items of the SF-6D questionnaire, which in turn can be converted from the items of the SF-36 questionnaire. The SF-6D score varies from 0 to 1, 0 representing worst health cost-utility and 1 best health utility.
Central Finland Hospital District
Other
Effect of Unloader Knee Brace and Biomechanical Footwear Device on Symptoms and Physical Function in Knee Osteoarthritis Patients - a Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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