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IRCT20200315046784N4 IRCT 2024-08-27 Iran University of Medical Sciences Effects of external knee supports with home-based exercise in knee osteoarthritis OA Comparison The Added Effect of External Knee Supports with Home-based Exercise on Pain, Physical Function and Muscular Performance in Patients with Mild to Moderate Degrees of Knee Osteoarthritis 2024-09-14 anticipated 60 Complete https://irct.ir/trial/77395 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The group allocation will be performed through permuted block randomization at an assignment ratio of 1:1:1. For allocation concealment, the randomization codes will be kept in opaque, sealed, sequentially numbered envelopes. Sample size is estimated at 54, however, to take account of potential withdrawals, 60 patients (n=20 per group) will be recruited for the study. First, create and seal 20 treatment A envelopes, 20 treatment B envelopes, and 20 treatment C envelopes. To create a block of 6, we will select 2 treatment A envelopes, 2 treatment B envelopes, and 2 treatment C envelopes. We will shuffle these 6 envelopes thoroughly, and place this block of 6 in a separate pile. Then, we will prepare additional blocks of 6 until all 20 treatment A, B, and C envelopes have been used. All additional blocks will be placed in their own individual piles. We will have 10 individuals piles of shuffled blocks of 6, Blinding description: The outcome assessor will be blinded to group allocation, because all dependent variables will be measured without the orthosis and or kinesiotape, and the patients will remove their orthosis / kinesiotape before referring for post-intervention assessment. Furthermore, all data will be encoded to prevent bias and to blind the statistician. N/A Knee Osteoarthritis. Intervention 1: Intervention group: home based exercise. Intervention 2: Intervention group: home-based exercise, and also Kinesiotape which will be reapplied every 3 days. Intervention 3: Intervention group: home-based exercise, and also flexible knee orthosis. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is not a plan to make this available.
public Fatemeh Azadinia
Shahnazari st., Mother Sq., Mirdamad Blvd
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 8051 azadinia.fatemeh@yahoo.com Iran University of Medical Sciences scientific Fatemeh Azadinia
Shahnazari st., Mother Sq., Mirdamad Blvd
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 8051 azadinia.fatemeh@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Kellgren and Lawrence grade 2 or 3 according to AP knee radiographs, the American College of Rheumatology classification criteria pain intensity of at least 4 standing and walking without assistance 50 years 65 years Both corticosteroid injection within the past 6 month Rheumatoid arthritis surgery and or other musculoskeletal disease of involved limb diabetes neurologic disease history of wearing knee orthoses or applying Kinesio-tape for the last 6 months taking medicine which affect nervous system and muscles allergic skin reaction BMI>36 M17 Osteoarthritis of knee Rehabilitation Rehabilitation Rehabilitation Intervention group: home based exercise Intervention group: home-based exercise, and also Kinesiotape which will be reapplied every 3 days Intervention group: home-based exercise, and also flexible knee orthosis Pain by visual analog scale (VAS). Timepoint: Before and after 6 weeks intervention. Method of measurement: Visual analog scale. Physical disability. Timepoint: Before and after 6 weeks intervention. Method of measurement: WOMAC questionnaire. Maximum voluntary isometric contraction. Timepoint: Before and after 6 weeks intervention. Method of measurement: Isokinetic Dynamometer. Force steadiness. Timepoint: Before and after 6 weeks intervention. Method of measurement: Isokinetic Dynamometer. Force sense. Timepoint: Before and after 6 weeks intervention. Method of measurement: Isokinetic Dynamometer. 30 seconds sit-to-stand test. Timepoint: Before and after 6 weeks intervention. Method of measurement: Counting the number of times the patient comes to a full standing position during 30 sec. Kinesiophobia. Timepoint: Before and after 6 weeks intervention. Method of measurement: Tampa scale. Iran University of Medical Sciences Approved 2024-05-11 Research Ethics Committees of Iran University of Medical Sciences Shahid Hemmat Highway Tehran Tehran Iran (Islamic Republic of)