]>
IRCT20221218056847N1 IRCT 2023-01-10 Semnan University of Medical Sciences effect of balance training on excitability of brain motor cortex Changes in Corticomotor Excitability of the Peroneal Muscles in People with Functional Ankle Instability Received Dynamic Balance Exercise: A Randomized Clinical Trial 2023-03-21 anticipated 38 Complete https://irct.ir/trial/67586 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Permuted block randomization method will be used for randomization. In this regard, blocks of four with numbers 1 to 6 will be used as follows: (in each block, a means the intervention group and b means the control group): 1-aabb 2-abba 3-abab 4-baba 5-baab 6-bbaa After choosing numbers one to six from the table of random numbers (numbers 0 and 7 to 9 are not taken into account), the block associated with each number is determined and the eligible people are enrolled in the study from left to right in each block and will be assigned in one of a or b group. The numbers will be selected nine times and the first 36 people will be grouped in this way, and the last two people will be entered into the group by assigning a coin. Participants, therapists, and evaluators will be unaware of the grouping. To implement the generated random sequence, the method of hiding the box or coded cans is used. In this method, the cans will be numbered based on a random sequence, and inside the boxes, the desired intervention will be given to the therapist with a sheet on which the random allocation is written, with the condition that the boxes are completely sealed and the therapist will assign patients to intervention and control groups based on the order of arrival, Blinding description: A physiotherapist will be in charge of the treatment process of the intervention group, and another physiotherapist will evaluate the desired variables. Therefore, the future study will be a single-blind study. N/A functional ankle instability. Intervention 1: Intervention group: The treatment in the interventiongroup (19 people) will include 18 session (6 weeks, 3 days per week, every other day) of static and dynamic balance exercises with biodex balance system. Balance exercises on the involved leg in each session will be include two statics (3 sets of 30 seconds) and four dynamics (3 sets of 6 repetitions for posterior-anterior and medial-lateral tilts, 1 set of 10 repetitions for clockwise and counterclockwise rotations). Instability of static exercises will be decrease from 11 and 7 in the first week to 6 and 2 in the sixth week, and in dynamic exercises from 7 to 2 (decreasing one degree per week). Intervention 2: Control group: no therapeutic action is considered for this group and this group will be evaluated and compared with the intervention group at the beginning and end of the study in terms of motor cortex excitability. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information.
public Mahdis Purzolfi Khansari
Neuromuscular Rehabilitation Research Center, Quds Blvd.
Semnan Iran (Islamic Republic of) 3519698375 +98 23 3332 8502 mahdispurzolfi@gmail.com Semnan University of Medical Sciences scientific Dr. Cyrus Taghizadeh Delkhoush
Neuromuscular Rehabilitation Research Center, Quds Blvd.
Semnan Iran (Islamic Republic of) 3519698375 +98 23 3332 8502 cyrustaghizadeh@yahoo.com Semnan University of Medical Sciences Iran (Islamic Republic of) at least once unilateral ankle sprain with grade II in last one to three years, which is followed by symptoms of pain, swelling and temporary loss of function. giving way a in the injured ankle, at least 2 times in the last 6 months less than 24 score in the CAIT questionnaire 20 - 60 years old 20 years 60 years Both ankle joint laxity Moderate to severe pain and swelling in the ankle Severe limitation of ankle range of motion surgery or fracture in the lower limbs neurovascular and musculoskeletal disorders in the lower limbs taking any medicine in last 2 weeks Participation in physical therapy in last 6 months systemic diseases or rheumatological disorders Balance and vestibular disorder brain surgery and head trauma of migraine and seizures metal or electric implant in body psychiatric disorders Pregnancy or breastfeeding S93.4 Sprain of ankle Treatment - Devices N/A Intervention group: The treatment in the interventiongroup (19 people) will include 18 session (6 weeks, 3 days per week, every other day) of static and dynamic balance exercises with biodex balance system. Balance exercises on the involved leg in each session will be include two statics (3 sets of 30 seconds) and four dynamics (3 sets of 6 repetitions for posterior-anterior and medial-lateral tilts, 1 set of 10 repetitions for clockwise and counterclockwise rotations). Instability of static exercises will be decrease from 11 and 7 in the first week to 6 and 2 in the sixth week, and in dynamic exercises from 7 to 2 (decreasing one degree per week). Control group: no therapeutic action is considered for this group and this group will be evaluated and compared with the intervention group at the beginning and end of the study in terms of motor cortex excitability. Motor evoked potential (MEP). Timepoint: Before and After the Intervention. Method of measurement: Transcranial Magnetic Stimulation and surface EMG. Cortical silence period (CSP). Timepoint: before and after treatment. Method of measurement: Transcranial Magnetic Stimulation and surface EMG. Self-reported functional ankle instability. Timepoint: before and after treatment. Method of measurement: cumberland ankle instability tools questionnaire. Semnan University of Medical Sciences Approved 2022-12-26 Research Ethics Committees of Semnan University Of Medical Sciences and Health Services Basij Blvd, Semnan University of Medical Sciences Semnan Semnan Iran (Islamic Republic of)