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IRCT20131225015932N15 IRCT 2019-11-23 Shiraz University of Medical Sciences Investigation the effect of valgus unloading knee brace on gait harmonic ratio in patients with medial compartment knee osteoarthritis Investigation the effect of valgus unloading knee brace on gait harmonic ratio in patients with medial compartment knee osteoarthritis 2019-11-24 anticipated 20 Complete https://irct.ir/trial/42518 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Subjects will be divided equally between the intervention and control groups according to the randomized block allocation method. How to allocate randomly by variable block method: Considering that there are two treatment modalities (Brace A and Control B) in this study, there will be six different conditions considering quadri blocks: 1-AABB 2-BBAA 3-ABAB 4-BABA 5-ABBA 6-BAAB Then we create random numbers using the computer. For numbers between 0 to 1/6 compound 1, numbers between 1/6 to 2/6 compound 2, numbers between 2/6 to 3/6 compound 3 and ... will be considered, Blinding description: After selecting the samples, one person (x) performs the evaluations on all subjects . After performing the measurements, another person (y) divides the patients into two groups, and then another person (z) applies the interventions to the patients. At the end of the study period (1 month), patients will be referred one week later and the person who performed the measurement (x) will repeat the measurements on all subjects. It is noteworthy that the measurements will be made without brace. So the person making the measurements will not be aware of the nature of the grouping of people. N/A Knee osteoarthritis. Intervention 1: Intervention group: Intervention group wear knee unloading valgus brace for 4 weeks, daily and 4 hours daily while standing and during daily activities and perform exercises which similar to control group. Patients are asked to record hours of use of the brace. Intervention 2: Control group: During the intervention, the control group performs similar exercises to the intervention group. Yes - There is a plan to make this available What will be shared: Study participants' personal data will be shared after unidentifiable individuals When: The access period begins 6 months after the results are published To whom: All academics as well as the public can access this data Conditions: The data will be made publicly available for further analysis with a citation Where to obtain: Dr. Alireza Motaleh, Rehabilitation Sciences school, Shiraz University of Medical Sciences, Chamran Boulevard, Abivardi Ave., Phone 00987136271551, Email Motealleh@sums.ac.ir How to obtain: 6 months after the results are published, people will be notified by email or phone Comments:
public Alireza Motealleh
Rehabilitation Sciences school, Abivardi Ave One , Chamran Boulevard, Shiraz
Shiraz Iran (Islamic Republic of) 71345-1733 +98 71 3627 1551 Motealleh@Sums.ac.ir Shiraz University of Medical Sciences scientific Alireza Motealleh
Rehabilitation Sciences school, Abivardi Ave One , Chamran Boulevard, Shiraz
Shiraz Iran (Islamic Republic of) 1733 -71345 +98 71 3627 1551 Motealleh@Sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Symptomatic unilateral knee osteoarthritis Knee medial compartment involvement Age 45-75 years Ability to walk at least 15 meters without auxiliary equipment K&L grade ≥2 (based on knee x-ray most related to one last year) PI-NRS ≥ 2 45 years 75 years Both Articular and lower extremity fractures History of knee and spine and lower extremity surgery in the past 6 months knee and hip replacement tibial osteotomy Any soft, neurological or vascular tissue problems where wearing a brace is harmful for the long term, including varicose veins and skin problems Obesity enough to make wearing a brace uncomfortable and uneffective (weighing more than 20% of ideal body weight) Systemic or metabolic diseases including diabetes Any condition or diseases other than osteoarthritis that affects walking, including stroke and Parkinson's chronic low back pain Ligamentous injuries of the lower extremities Other rheumatologic diseases except knee osteoarthritis M17 Osteoarthritis of knee Rehabilitation Rehabilitation Intervention group: Intervention group wear knee unloading valgus brace for 4 weeks, daily and 4 hours daily while standing and during daily activities and perform exercises which similar to control group. Patients are asked to record hours of use of the brace Control group: During the intervention, the control group performs similar exercises to the intervention group Harmonic ratio measured with accelerometer. Timepoint: Baseline (before intervention) and one week after intervention (one month intervention). Method of measurement: Based on studies to calculate the harmonic gait ratio, accelerometer (Biomethrics) will be fitted to the lower lumbar vertebrae(l4-l5) at the lower back. Gait analysis will be performed using an accelerometer in the laboratory environment as individuals walk a 15-meter-long, horizontal path at their usual speed; a heel switch will be connected in the heel area of right foot to define the start of the walking cycle ; the linear acceleration of the trunk will be sampled along the anterior-posterior, medial-lateral, and vertical axes at a frequency of 200 Hz. Signal processing will be performed using matlab software. To calculate the harmonic ratio using fourier transformation, the contents of the in phase accelerated signals (even harmonics) are compared to the contents of out-of-phase signals (odd harmonics). Pain and disability measered with KOOS quationniare. Timepoint: Baseline (before intervention) and one week after intervention (one month intervention). Method of measurement: KOOS Questionnaire: Knee Injury and Osteoarthritis Outcome Score This questionnaire contains 42 items that assess the patient's opinion on the five dimensions related to the knee and its problems, including: pain (9 questions), other specialized symptoms of illness (7 Questions), daily life performance (17 questions), recreational and sports performance (5 questions), and knee-related quality of life (4 questions). Balance. Timepoint: Baseline (before intervention) and one week after intervention (one month intervention). Method of measurement: Star Equilibrium Test: To do this test, 8 strip strips with a 45 degree angle are attached to the ground. Evaluation will be done with the bare foot, and the patient will be asked to stand in the center of the star with the leg that is stance positioned and center the arch, while maintaining the balance on the leg in the center, and with the other foot touch the longest distance on any tape. Pain meassured with PI-NRS (Pain intensity numeric range scale). Timepoint: Baseline (before intervention) and one week after intervention (one month intervention). Method of measurement: An 11-point scale that reports the patient's pain level. The patient is asked to choose a number between 0 and 10 that is most proportional to their pain intensity. Isometric strength of quadriceps. Timepoint: Baseline (before intervention) and one week after intervention (one month intervention). Method of measurement: Isometric quadriceps muscle strength will be measured using a handheld dynamometer. Shiraz University of Medical Sciences Approved 2019-10-09 Ethics committee of Shiraz University of Medical Sciences Rehabilitation school of Shiraz University of Medical Sciences, Abivardi Ave., Chamran Boulevard shiraz Fars Iran (Islamic Republic of)