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IRCT20181003041219N1 IRCT 2018-11-03 Iran University of Medical Sciences The effect of hybrid knee brace on acute anterior cruciate ligament tear The effect of hybrid knee brace on coping ability and neuromuscular parameters after acute anterior cruciate ligament tear 2018-11-03 anticipated 26 Complete https://irct.ir/trial/34363 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: So far, a study based on orthosis intervention in the acute stage of the anterior cruciate ligament rupture has not been done to increase the number of copers. The result of the present study may increase the number of copers and reduce the likelihood of reconstruction surgery. Another aspect of this study is introducing a hybrid brace that benefits from the use of hard and soft braces simultaneously and also changes in the structure of the hard part for specific instability control after anterior cruciate ligament rupture. Finally, the effect of using the hybrid brace is evaluated by measuring the quadriceps steadiness, which indicates the level of coordination of the musculoskeletal system after the intervention, Randomization description: In this study, simple randomization method will be used. 26 cards, numbered from 1 to 26, are poured into the container. Then, each time, a card containing one number is randomly taken out of the container. In this way, 13 cards are selected and the registration number is considered as the numbers of test group. The remaining numbers in the container are considered as the control group. Subsequently, people entering the study according to inclusion criteria are randomized in the test or control group, respectively, Blinding description: In this study, blindness is done in one direction. So that the participants in the study do not know if they are in the control or test group. A specialist physician who will evaluate and refer patients will also be blind. N/A Anterior cruciate ligament rupture. Intervention 1: Intervention group: Individuals with acute anterior cruciate ligament rupture, intervention including using a hybrid brace for one month, and performing routine physiotherapy for ten sessions to reduce pain, edema and increase knee range of motion, then determine the person's compatibility with injury and measure the stability of the quadriceps muscle by Biodex Isokinetic dynamometer. Intervention 2: Control group: Individuals with acute rupture of the anterior cruciate ligament, routine intervention including ten sessions of physiotherapy to reduce pain, edema and increase knee range of motion, then determine the person's compatibility with injury and measure the stability of the quadriceps muscle by Biodex Isokinetic dynamometer. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Maryam Jalali
Madadkaran Alley, Shahnazari street, Mirdamad Blvd.
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 7124 marjalali@gmail.com Iran University of Medical Sciences scientific Maryam Jalali
Madadkaran Ave., Shahnazari St., Mirdamad Blvd.
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 7124 marjalali@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Unilateral isolated tear of anterior cruciate ligament Injury within last three month Required 3-5 scores from Tegner questionnaire 18 years 40 years Both The presence of damage to the meniscus confirmed by MRI The presence of cartilage damage The presence of fracture or dislocation with ACL rupture The history of fracture and previous surgery in the knee joint The history of previous ACL or meniscal or other ligaments injuries S83.51 Sprain of anterior cruciate ligament of knee Rehabilitation Rehabilitation Intervention group: Individuals with acute anterior cruciate ligament rupture, intervention including using a hybrid brace for one month, and performing routine physiotherapy for ten sessions to reduce pain, edema and increase knee range of motion, then determine the person's compatibility with injury and measure the stability of the quadriceps muscle by Biodex Isokinetic dynamometer Control group: Individuals with acute rupture of the anterior cruciate ligament, routine intervention including ten sessions of physiotherapy to reduce pain, edema and increase knee range of motion, then determine the person's compatibility with injury and measure the stability of the quadriceps muscle by Biodex Isokinetic dynamometer Quadriceps steadiness. Timepoint: Acute stage. Method of measurement: Biodex dynamometer. Iran University of Medical Sciences Approved 2018-07-10 Ethics Committee of Iran University of Medical Sciences Hemmat highway Tehram Tehran Iran (Islamic Republic of)