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IRCT20210417050997N1 IRCT 2021-07-05 Razi University The Effect of Neruomuscular Exercises in Patients with Knee Osteoarthritis The Effect of Neruomuscular Exercises in Combination with Cognitive-Motivational and Mindfulness Interventions on Pain, Function, Neurofeedback Factores, Kinesiophobia, and Self-Reported Knee Instability Improvement in Patients with Knee Osteoarthritis 2021-08-01 anticipated 45 Complete https://irct.ir/trial/55764 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: Subjects will be randomized based on Random Number Generator software and then assigned to three groups based on SNOSE allocation concealment. Participants will be randomly assigned to one of the groups of neuromuscular exercises with motivational cognitive interventions, neuromuscular exercises with mindfulness interventions and control group. So that 15 people were identified for group one, 15 people for group two and 15 people for control group, Blinding description: In this study, the researcher will have no information about the exercises and interventions assigned to the groups, the subjects will be unaware of the existence of parallel groups, as well as the possibility of not informing the person who is analyzing the data. There will be groups and exercises assigned to them. N/A Knee osteoarthritis. Intervention 1: Intervention group: Neuromuscular Exercises with Motivational Cognitive Interventions. Intervention 2: Intervention group: Neuromuscular Exercises with Mindfulness and Neurofeedback Interventions. Intervention 3: Control group: Neuromuscular training group In this group, exercises will be performed three times a week for 6 weeks and 60 minutes in 2 to 3 sets with 10-15 repetitions and rest and three levels between exercises and sets. Difficulty was considered for each exercise. These exercises will be performed on both healthy and diseased feet, although the focus is on the injured foot. Intervention 4: Intervention group 1: Neuromuscular exercises with cognitive-motivational interventions such as control group Neuromuscular exercises in addition to ten - 15 minutes of motivational interview exercises in the form of motivational speeches designed according to the table and showing motivational images and functional images to the elderly in person and online In 8 sessions along with 8 weeks of neuromuscular training. Intervention 5: Intervention group 2 :Performing neuromuscular exercises Like the control group, with mindfulness exercises based on stress reduction for ten to fifteen minutes per session along with 8 weeks of neuromuscular exercises. 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 no more information
public Liana Chaharmahali
No.1, Ariana Complex, Shahbazbegian Alley, Hamedan Town
Hamedan Iran (Islamic Republic of) 6515773664 +98 81 3825 2426 lianach2017@yahoo.com Razi University scientific Farzaneh Gandomi
Taghe Bostan, Baghe Abrisham, Daneshgah Blv. Kermanshah Town
Kermanshah Iran (Islamic Republic of) 6715663136 009834274573 gandomi777@gmail.com Razi University Iran (Islamic Republic of) Age over 40 years Having clinical criteria for osteoarthritis of the knee of the College of Rheumatology Have a score of at least 2 on the Kelgren and Lawrence criteria Chronic knee pain for at least 3 months Pain score 8-6 of the VAS scale Without use any type of psychological intervention / other counseling during periods that subjects are studying. 40 years 60 years Female Age under 40 years Body mass index greater than or equal to (BMI> 40kg / m2), Additional orthopedic injuries in the lower extremities Neuromuscular disorders that interfere with daily functioning (such as stroke, uncontrolled muscle stiffness, MS and Parkinson's) that interfere with the exercise program Fractures and surgery in the lower extremities Taking psychiatric medication or seeing a behavioral specialist in the past six months that prevents you from exercising M17.2 Bilateral post-traumatic osteoarthritis of knee Other Other Other Other Other Intervention group: Neuromuscular Exercises with Motivational Cognitive Interventions Intervention group: Neuromuscular Exercises with Mindfulness and Neurofeedback Interventions Control group: Neuromuscular training group In this group, exercises will be performed three times a week for 6 weeks and 60 minutes in 2 to 3 sets with 10-15 repetitions and rest and three levels between exercises and sets. Difficulty was considered for each exercise. These exercises will be performed on both healthy and diseased feet, although the focus is on the injured foot. Intervention group 1: Neuromuscular exercises with cognitive-motivational interventions such as control group Neuromuscular exercises in addition to ten - 15 minutes of motivational interview exercises in the form of motivational speeches designed according to the table and showing motivational images and functional images to the elderly in person and online In 8 sessions along with 8 weeks of neuromuscular training Intervention group 2 :Performing neuromuscular exercises Like the control group, with mindfulness exercises based on stress reduction for ten to fifteen minutes per session along with 8 weeks of neuromuscular exercises Evaluation of pain on a visual scale of pain. Timepoint: Before the intervention, after 45, 60 days after the start of Neuromuscular Exercises. Method of measurement: visual scale of pain(VAS). Function. Timepoint: Before the intervention, after 45, 60 days after the start of Neruomuscular Exercises. Method of measurement: Western Ontario and McMasters Universities Osteoarthritis Index(WOMAC). Quality of Life. Timepoint: Before the intervention, after 45, 60 days after the start of Neruomuscular Exercises. Method of measurement: The World Health Organization Quality of Life(SF36). Kinesiophobia. Timepoint: Before the intervention, after 45, 60 days after the start of Neruomuscular Exercises. Method of measurement: Tampa scale. Knee contracture. Timepoint: Before the intervention, after 45, 60 days after the start of Neruomuscular Exercises. Method of measurement: Universal goniometer. Balance. Timepoint: Before the intervention, after 45, 60 days after the start of Neruomuscular Exercises. Method of measurement: Berg balance scale-Biodex Stability System (BSS). Neurofeedback factors. Timepoint: Before the intervention, after 45, 60 days after the start of Neruomuscular Exercises. Method of measurement: With ProCamp Infini device and Infinity Biography software. Sole pressure distribution. Timepoint: Before the intervention, after 45, 60 days after the start of Neruomuscular Exercises. Method of measurement: with foot pressure measurement system(FScan II). Knee instability. Timepoint: Before the intervention, after 45, 60 days after the start of Neruomuscular Exercises. Method of measurement: Felson Questionnaire. Knee proprioception. Timepoint: Before the intervention, after 45, 60 days after the start of Neruomuscular Exercises. Method of measurement: Universal goniometer. Knee flexion (ROM). Timepoint: Before the intervention, after 45, 60 days after the start of Neruomuscular Exercises. Method of measurement: Universal goniometer. Razi University Approved 2021-02-24 Ethics Commitee of Kermanshah University of Medical Sciences Center No. 2, Shahid Beheshti Blvd, Kermanshah Town Kermanshah Kermanshah Iran (Islamic Republic of)