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IRCT20220220054068N1 IRCT 2022-06-21 Semnan University of Medical Sciences Comparison of Spinal Excitability in People with Functional Ankle Instability Received Dynamic Versus Static Balance Exercise; A Randomized Clinical Trial Comparison of Spinal Excitability in People with Functional Ankle Instability Received Dynamic Versus Static Balance Exercise; A Randomized Clinical Trial 2022-07-06 anticipated 57 Complete https://irct.ir/trial/62041 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individuals who are eligible to study are randomly assigned to unblocked blocks in three groups. Will group randomly. The first group undergoes static balance exercises and the second group undergoes dynamic balance exercises. And in the third group, as an control group, there will be no intervention. Sampling method in this study is simple sampling. Samples are assigned (to three groups) randomly using the Permuted Block Randomization method with 6 blocks of 6 assigned to 3 groups. In this method, A will represent group one (static balance exercises), B will represent group two (dynamic balance exercises) and C will represent the control group. In this way, the order of interventions A, B and C in the form of blocks from 1 to 6 by the methodological consultant of the project is determined as described in the table below and provided to the executive supervisor of the project and the researcher to assign each qualified person to the supervisor. The executive gets the homework. The supervisor first selects the block using a random number generator (or dice) and then the eligible individuals are assigned to one of three groups A, B or C in a predetermined order, Blinding description: To reduce the bias in the study, the lead researcher will perform all the treatment steps and the evaluation steps before and after the intervention will be the responsibility of the research assistant who is a physiotherapist with 5 years of clinical experience. The evaluator is not aware of the individual's treatment. Participants in each group will also be unaware of the treatment and type of intervention of the other group, so this study is a double-blind randomized clinical trial. N/A People with functional ankle instability; Spinal excitability; Postural stability;. Intervention 1: Intervention group: The balance exercise program is such that the exercises will be performed on a Biodex balance system.The first group (dynamic balance exercises): In this case, the plate under the foot of the person is moving and will be on the level of stability (9).The type of exercises are as follows: Week 1: Day 1: Standing on two legs with eyes open Day 2 and 3: Standing on two legs with eyes closed Week 2: Standing on one leg with eyes Open Week 3: Standing on one leg with eyes Week 4 package: Standing on one leg with your eyes closed, the exercise will be repeated in 3 sets of 10 so that the patient will rest for 1 minute sitting on a chair between each exercise. Rest between each set is 3 minutes while sitting on a chair.The duration of each exercise is 20 seconds. The patient should hold the marker in the center of the circle. Participants in each group (group one: dynamic balance exercises: the plate under the participant's foot is movable, group 2: static balance exercises: the plate under the participant's foot is fixed) balance exercises They will do it for 4 weeks (3 sessions per week). Intervention 2: Intervention group: The balance exercise program is such that the exercises will be performed on a Biodex balance system. Static balance): In this case, the plate under the person's foot will be fixed.The type of exercises are as follows: Week 1: Day 1: Standing on two legs with eyes open Day 2 and 3: Standing on two legs with eyes closed Week 2: Standing on one leg with eyes Open Week 3: Standing on one leg with eyes Week 4 package: Standing on one leg with your eyes closed, the exercise will be repeated in 3 sets of 10 so that the patient will rest for 1 minute sitting on a chair between each exercise. Rest between each set is 3 minutes while sitting on a chair.The duration of each exercise is 20 seconds. The patient should hold the marker in the center of the circle. Participants in each group (group one: dynamic balance exercises: the plate under the participant's foot is movable, group 2: static balance exercises: the plate under the participant's foot is fixed) balance exercises They will do it for 4 weeks (3 sessions per week). Intervention 3: Control group: The third group (control group) that no intervention will be performed. 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 No more information
public Cyrus Taghizade Delkhosh
Semnan University of Medical Sciences, Basij Blvd
Semnan Iran (Islamic Republic of) 3513138111 +98 23 3365 4180 Cyrustaghizadeh@yahoo.com Semnan University of Medical Sciences scientific Cyrus Taghizade Delkhosh
Semnan University of Medical Sciences, Basij Blvd
Semnan Iran (Islamic Republic of) 3513138111 +98 23 3365 4180 Cyrustaghizadeh@yahoo.com Semnan University of Medical Sciences Iran (Islamic Republic of) History of no ankle sprains in the last 3 months History of non-ankle sprain in the opposite limb Having a score of 24> in the CAIT questionnaire Patients in whom the severity of the sprain was grade 2 or 3 but did not have surgery. Age between 18_35 years 18 years 35 years Both Existence of pain in the ankle joint Existence swelling in the ankle joint Have a history of diabetes or any rheumatic disorder or systemic disease that may interfere with sensory input History of any soft or hard tissue damage to any of the lower limbs History of seizures History of concussion in the last 6 months History of any surgery on any of the lower limbs Existence of any limitation of function or range of motion of the ankle History of vestibular injury, vision and balance History of using a variety of sleeping pills and antidepressants and stress Rehabilitation Rehabilitation Rehabilitation Intervention group: The balance exercise program is such that the exercises will be performed on a Biodex balance system.The first group (dynamic balance exercises): In this case, the plate under the foot of the person is moving and will be on the level of stability (9).The type of exercises are as follows: Week 1: Day 1: Standing on two legs with eyes open Day 2 and 3: Standing on two legs with eyes closed Week 2: Standing on one leg with eyes Open Week 3: Standing on one leg with eyes Week 4 package: Standing on one leg with your eyes closed, the exercise will be repeated in 3 sets of 10 so that the patient will rest for 1 minute sitting on a chair between each exercise. Rest between each set is 3 minutes while sitting on a chair.The duration of each exercise is 20 seconds. The patient should hold the marker in the center of the circle. Participants in each group (group one: dynamic balance exercises: the plate under the participant's foot is movable, group 2: static balance exercises: the plate under the participant's foot is fixed) balance exercises They will do it for 4 weeks (3 sessions per week). Intervention group: The balance exercise program is such that the exercises will be performed on a Biodex balance system. Static balance): In this case, the plate under the person's foot will be fixed.The type of exercises are as follows: Week 1: Day 1: Standing on two legs with eyes open Day 2 and 3: Standing on two legs with eyes closed Week 2: Standing on one leg with eyes Open Week 3: Standing on one leg with eyes Week 4 package: Standing on one leg with your eyes closed, the exercise will be repeated in 3 sets of 10 so that the patient will rest for 1 minute sitting on a chair between each exercise. Rest between each set is 3 minutes while sitting on a chair.The duration of each exercise is 20 seconds. The patient should hold the marker in the center of the circle. Participants in each group (group one: dynamic balance exercises: the plate under the participant's foot is movable, group 2: static balance exercises: the plate under the participant's foot is fixed) balance exercises They will do it for 4 weeks (3 sessions per week). Control group: The third group (control group) that no intervention will be performed 1. Determining the effect of dynamic balance exercises on changes in spinal excitability of the soleus muscle when prone lying 2. Determining the effect of dynamic balance exercises on changes in spinal excitability of the soleus muscle while single leg standing 3. Determining the effect of dynamic balance exercises on changes in spinal excitability of soleus muscle while double leg standing 4. Determining the effect of static balance exercises on changes in spinal excitability of soleus muscle while prone lying 5. Determining the effect of static balance exercises on changes in spinal excitability of the soleus muscle while single leg standing 6. Determining the effect of static balance exercises on changes in spinal excitability of soleus muscle while double leg standing 7. Determining the effect of dynamic balance exercises on postural stability of FAI(functional ankle instability) individuals 8. Determining the effect of static balance exercises on postural stability of FAI individuals 9. Comparison of changes in spinal excitability of soleus muscle in prone position after treatment between the two intervention groups 10. Comparison of changes in spinal excitability of soleus muscle in single leg standing position after treatment between the two intervention groups11. Comparison of changes in spinal excitability of soleus muscle in double leg standing position after treatment between the two intervention groups 12. Comparison of postural stability after treatment between the two intervention groups 13. Comparison of functional disability of the affected limb after treatment between the two intervention groups. Timepoint: Measurements of spinal excitation, postural stability and functional disability of the ankle will be before the intervention and immediately after the intervention and one month after the intervention. Method of measurement: Spinal excitability using Hoffman's reflex ratio to M-wave and using electromyography device; Postural stability using a Biodex device; Functional disability rate using Cumberland Ankle Instability Tool Questionnaire. Semnan University of Medical Sciences Approved 2022-05-25 Ethics committee of Semnan University of Medical Sciences No. 37, Bighdeli Alley., Mehran Ave., Shahrake Shariati., Khaniabadnoo Tehran Tehran Iran (Islamic Republic of)