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IRCT20230430058033N1 IRCT 2023-05-04 The University of Bu Ali Sina Investigating the effect of motor motor control, neurological and cognitive exercises on non-specific chronic back pain The effect of motor control, neurological and cognitive exercises on psychological and kinetic variables of gait in patients with chronic nonspecific low back pain 2023-05-10 anticipated 100 Complete https://irct.ir/trial/69898 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: Patients were randomized based on Random Number Generator software.In addition to simple randomization, random sequence generation softwares are capable of generating random sequences by block method.Nowadays, due to its ease of use and saving time, this method has replaced other random sequence generation methods. And then, based on the concealment of the SNOSE method, the allocation is divided into one of four groups: motor control exercises, motor control exercises along with neurofeedback exercises.Movement control exercises along with cognitive exercises and combined group (motor control exercises, neurofeedback exercises and cognitive exercises) will be assigned.This method is one of the common methods of hiding random allocation.In this method, first, a random sequence is created by the Random Number Generator software, then, based on the sample size of the research, a number of envelopes with aluminum foil (for the lack of clarity of the contents of the envelopes), preparation and each of the random sequences created on A card is recorded and the cards are placed in the letter envelopes in order.In order to preserve the random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box in order.At the time of the registration of the participants, according to the order of entry of the eligible participants into the study, one of the letter envelopes will be opened and the assigned group of that participant will be revealed, Blinding description: During the initial test before the beginning of the training period and also the secondary test after the training, the researcher was not involved in the tests in any way and the tests were done by people who did not know about the plan.They were aware and acted completely anonymously according to the orders. The person who was in charge of analyzing the data did not know about the study and examined the data in general. N/A Chronic non-specific back pain. Intervention 1: Intervention group: Movement control exercises in eight weeks, three sessions a week and each session about 60 minutes (n=25). Movement control exercises will be performed in eight weeks, three sessions a week and each session will last about 60 minutes under the supervision of the researcher for all four exercise groups in the same way.This part will include about 10 minutes of general warm-up, about 40 minutes of movement control exercises and 10 minutes of cooling exercises in the form of stretching exercises.The movement control exercise program is based on the treatment program of Hodges et al. (2007).The primary goal of these exercises is to enable the patient to achieve control and coordination of the spine and pelvis using the principles of motor learning. Intervention 2: Intervention group: The group of motor control and neurofeedback exercises is a combination of two motor control and neurofeedback approaches.(n=25). Neurofeedback exercises will be conducted individually in the psychology laboratory of Bo Ali Sina University, Hamedan, 3 times a week for 30 minutes during eight weeks. The selected protocol for neurofeedback exercises will be in accordance with previous studies in the form of increasing the sensorimotor rhythm and decreasing beta and theta in the CZ region.Brain waves are processed by an amplifier and a computer device and provide appropriate feedback. The feedback process is like a person playing a computer game on his monitor.Unlike common games, a person does not use his hand to control the game, but does it through his brain waves. Intervention 3: Intervention group: The group of motor and cognitive control exercises is a combination of two motor and cognitive control approaches (n= 25). Cognitive exercises will be done individually for eight weeks, 3 sessions a week for 30 minutes in the psychology laboratory of Bo Ali Sina University, Hamedan. It will include listening to the patient's full story about their pain. This careful examination is essential in order to broadly identify modifiable multidimensional drivers of pain and disability (pain-triggering cognitive behaviors, movement, and lifestyle) for each participant.Each patient receives an individual targeted intervention aimed at changing individual cognitive, motor and lifestyle behaviors. Intervention 4: Intervention group: the combined group of motor control and neurocognitive exercises (n=25). In this way, movement control exercises will be performed on even days and neurological and cognitive exercises will be performed on odd days. Yes - There is a plan to make this available What will be shared: All data and documentation can be shared, but with the unidentifiable of people and private information for subjects When: Starting Data access 1 year after printing results To whom: Researchers who conduct research in this direction are allowed to take action to receive documents Conditions: Only the type of analysis that can be done in the research can be redefined.It can also use the training protocol. Obligation not to misuse research data Where to obtain: azadehasgarpoor@gmail.com How to obtain: When the applicant submits a documents for her/his work area in relation to the subject matter of the thesis and if the request is reasonable and the commitment not to misuse the data of this research, the data will be sent to him within 1 week of work Comments:
public Azadeh Asgarpoor
No. 4, Imam Reza Blvar, Moalem Square
Shahre Kord Iran (Islamic Republic of) 888-1111-311 +98 38 3224 1992 azadehasgarpoor@gmail.com The University of Bu Ali Sina scientific Azadeh Asgarpoor
No 4, Imam Reza Blvar, Moalem Square
Shahrekord Iran (Islamic Republic of) 888-1111-311 +98 38 3224 1992 azadehasgarpoor@gmail.com The University of Bu Ali Sina Iran (Islamic Republic of) Women between the ages of 30 and 60 Diagnosis and confirmation of non-specific chronic back pain by a specialist doctor Not participating in other sports activities Presence of at least two movement control disorders in Lomajoki movement control tests 30 years 60 years Female Having a history of injury in the past year in the trunk and lower limbs A history of surgery in the back and lower limbs People with back pain of non-mechanical origin Participants if they have already experienced neurofeedback S30.0XXS Contusion of lower back and pelvis, sequela Rehabilitation Rehabilitation Rehabilitation Rehabilitation Intervention group: Movement control exercises in eight weeks, three sessions a week and each session about 60 minutes (n=25). Movement control exercises will be performed in eight weeks, three sessions a week and each session will last about 60 minutes under the supervision of the researcher for all four exercise groups in the same way.This part will include about 10 minutes of general warm-up, about 40 minutes of movement control exercises and 10 minutes of cooling exercises in the form of stretching exercises.The movement control exercise program is based on the treatment program of Hodges et al. (2007).The primary goal of these exercises is to enable the patient to achieve control and coordination of the spine and pelvis using the principles of motor learning. Intervention group: The group of motor control and neurofeedback exercises is a combination of two motor control and neurofeedback approaches.(n=25). Neurofeedback exercises will be conducted individually in the psychology laboratory of Bo Ali Sina University, Hamedan, 3 times a week for 30 minutes during eight weeks. The selected protocol for neurofeedback exercises will be in accordance with previous studies in the form of increasing the sensorimotor rhythm and decreasing beta and theta in the CZ region.Brain waves are processed by an amplifier and a computer device and provide appropriate feedback. The feedback process is like a person playing a computer game on his monitor.Unlike common games, a person does not use his hand to control the game, but does it through his brain waves Intervention group: The group of motor and cognitive control exercises is a combination of two motor and cognitive control approaches (n= 25). Cognitive exercises will be done individually for eight weeks, 3 sessions a week for 30 minutes in the psychology laboratory of Bo Ali Sina University, Hamedan. It will include listening to the patient's full story about their pain. This careful examination is essential in order to broadly identify modifiable multidimensional drivers of pain and disability (pain-triggering cognitive behaviors, movement, and lifestyle) for each participant.Each patient receives an individual targeted intervention aimed at changing individual cognitive, motor and lifestyle behaviors. Intervention group: the combined group of motor control and neurocognitive exercises (n=25). In this way, movement control exercises will be performed on even days and neurological and cognitive exercises will be performed on odd days. Muscle activity. Timepoint: At the beginning of the study before the interventions and 60 days after the exercises. Method of measurement: EMG A device for measuring muscle activity. Vertical earth reaction force. Timepoint: At the beginning of the study before the interventions and 60 days after the exercises. Method of measurement: Foot pressure measuring device. Brain Waves. Timepoint: At the beginning of the study before the interventions and 60 days after the exercises. Method of measurement: Neurofeedback device. Cognitive function. Timepoint: At the beginning of the study before the interventions and 60 days after the exercises. Method of measurement: Fully listening to the patient in order to widely identify multidimensional stimuli that can change pain and disability (cognitive behaviors that trigger pain, movement, and lifestyle). Visual measurement of pain. Timepoint: At the beginning of the study before the interventions and 60 days after the exercises. Method of measurement: Use the Visual Analogue Scale. Disability. Timepoint: At the beginning of the study before the interventions and 60 days after the exercises. Method of measurement: Oswestry Disability Questionnaire. Quality of Life. Timepoint: At the beginning of the study before the interventions and 60 days after the exercises. Method of measurement: Shernborn SF36 Questionnaire. The University of Bu Ali Sina The University of Bu Ali Sina The University of Bu Ali Sina Approved 2022-09-14 Ethics Committee of Buali Sina Hamadan University Pajohesh Intersection, Mahdieh Street Hamedan Hamadan Iran (Islamic Republic of)