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IRCT20200315046784N6 IRCT 2025-07-15 Iran University of Medical Sciences effects of knee orthosis and home-based exercise in knee osteoarthritis The added effect of knee orthosis with home-based exercise (tele-rehabilitation) on pain, physical function and thickness of the quadriceps muscle in patients with mild to moderate degrees of knee osteoarthritis 2025-07-26 anticipated 50 Complete https://irct.ir/trial/84221 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. For allocation concealment, the randomization codes will be kept in opaque, sealed, sequentially numbered envelopes. Sample size is estimated at 44, however, to take account of potential withdrawals, 50 patients (n=25 per group) will be recruited for the study. First, create and seal 25 treatment A envelopes, and 25 treatment B envelopes. To create a block of 6, we will select 3 treatment A envelopes, and 3 treatment B envelopes. These 6 envelopes will be shuffled thoroughly, and place this block of 6 in a separate pile. To create a block of 4, we will select 2 treatment A envelops, and 2 treatment B envelopes. Then, we will prepare additional blocks of 6 and 4 until all 25 treatment A, and B envelopes have been used. All additional blocks will be placed in their own individual piles. We will have 3 individuals piles of shuffled blocks of 6, and 8 individuals piles of shuffled blocks of 4, Blinding description: The outcome assessor will be blinded to group allocation, because all dependent variables will be measured without the orthosis and the patients will remove their orthosis 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, and also flexible knee orthosis. Participants will be asked to wear flexible knee orthosis for 8 weeks except when sleeping or showering. Participants will receive 3 home-based exercise sessions (each session 30-40 minutes) per week for 8 weeks. Exercises will include: Passive knee flexion, Passive knee extension, Isometric quadriceps contraction, Supine Straight leg lift, Leg lift in prone position, Shifting the center of mass, Resistance knee flexion, Resistance knee extension. Intervention 2: Intervention group: home based exercise. They will receive the same exercises as the other group, but they will not receive 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 It is not yet known if there will be 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 Pain intensity greater than 4 based on VAS standing and walking without assistance 50 - 65 years old 50 years 65 years Both History of surgery or trauma in osteoarthritic limb Physical therapy, chiropractic, or acupuncture treatment, or knee-specific exercises in the past 6 months oral or intra-articular corticosteroid use within the past 6 months or any other intra-articular injections such as hyaluronic acid or PRP Uncontrolled blood pressure, heart disease, insulin-dependent diabetes, impaired kidney function, use of medications that cause dizziness, nervous system disorders, taking muscle relaxant medications history of wearing knee orthoses in past 6 months allergic skin reaction other types of arthritis such as Rheumatoid arthritis BMI>30 M17 Osteoarthritis of knee Rehabilitation Rehabilitation Intervention group: home-based exercise, and also flexible knee orthosis. Participants will be asked to wear flexible knee orthosis for 8 weeks except when sleeping or showering. Participants will receive 3 home-based exercise sessions (each session 30-40 minutes) per week for 8 weeks. Exercises will include: Passive knee flexion, Passive knee extension, Isometric quadriceps contraction, Supine Straight leg lift, Leg lift in prone position, Shifting the center of mass, Resistance knee flexion, Resistance knee extension. Intervention group: home based exercise. They will receive the same exercises as the other group, but they will not receive knee orthosis. Pain via visual analog scale(VAS). Timepoint: Before and after 8 weeks intervention. Method of measurement: visual analog scale(VAS). Physical function. Timepoint: Before and after 8 weeks intervention. Method of measurement: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire. Quadriceps muscle thickness. Timepoint: before and after 8 weeks intervention. Method of measurement: Ultrasound. Functional mobility via Timed-Up and Go (TUG). Timepoint: before and after 8 weeks intervention. Method of measurement: TUG: measuring the time to get up from a chair, walking at certain distance, turn around, return to the chair, and sitting down again. Kinesiophobia. Timepoint: before and after 8 weeks intervention. Method of measurement: Tampa scale. Lower limb muscles function via sit-to-stand test. Timepoint: before and after 8 weeks intervention. Method of measurement: Counting the number of times the patient comes to a full standing position during 30 sec. Iran University of Medical Sciences Approved 2025-05-25 Research Ethics Committees of Iran University of Medical Sciences Shahid Hemmat Highway Tehran Tehran Iran (Islamic Republic of)