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IRCT20230203057314N1 IRCT 2023-06-02 Tehran University of Medical Sciences Immediate Effects of Blood Flow Restriction Combined with Whole Body Vibration in Chronic Ankle Instability Immediate Effects of Blood Flow Restriction Combined with Whole Body Vibration on Balance and Proprioception in Non-professional Athletes with Chronic Ankle Instability 2023-04-03 anticipated 38 Complete https://irct.ir/trial/69259 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple non-probability randomization is done using the numbered and sealed envelope method. With the help of physiotherapist 1 (evaluator), patients are randomly divided into 2 intervention and control groups through the sealed envelope method. be. For this purpose, 38 envelopes are prepared, which are filled with the numbers 1 and 2 (19 envelopes containing the number 1 and 19 envelopes containing the number 2). The numbers 1 and 2 each separately means entering one of the intervention and control groups, which only physiotherapist 2 (therapist) knows about. Before the patient chooses the envelope, we will change the order of the envelopes several times, and after the patient chooses the envelope, its number is noted on the evaluation sheet, Blinding description: The participants and the evaluating physiotherapist are blinded to the study groups. Both groups of patients receive whole body vibration treatment, and in one group, the cuff around the thigh is filled with air, and in the other group, it is simply closed without filling with air, and the patients do not see any difference between the two groups. The evaluating physiotherapist does not know which treatment group each patient is in, and the assignment of patients to two groups is done by the treating physiotherapist. N/A chronic ankle sprain. Intervention 1: Intervention group: Blood flow restriction combined with whole body vibration using whole body vibration device and blood flow restriction device for a single treatment session for 6 minutes. Intervention 2: Control group: Whole body vibration alone. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: 2024 To whom: Researchers working in academic institutions Conditions: Students Where to obtain: a-bajalan@tums.ac.ir How to obtain: no Comments:
public Dr nastaran ghotbi
Faculty of Rehabilitation , corner of Safi Alishah St., Enqelab St. , tehran city
tehran Iran (Islamic Republic of) 11489-65111 +98 21 7753 4133 nghotbi@sina.tums.ac.ir Tehran University of Medical Sciences scientific Dr nastaran ghotbi
Faculty of Rehabilitation , Corner of Safi Alishah St., Enqelab St. , Tehran city
Tehran Iran (Islamic Republic of) 11489-65111 +98 21 7753 4133 nghotbi@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Non-professional Athlete Age range from 18 to 35 years Male and female gender Having at least one ankle sprain in one of the ankles, the first history of the sprain occurred at least one year before the study and was associated with inflammatory symptoms and caused the person to be unable to participate in desired physical activities for at least one day. A score less than or equal to 24 in the Cumberland questionnaire Having a history of ankle giving way or recurrent ankle sprain or a feeling of instability in the injured ankle 18 years 35 years Both People who have had an acute injury (including sprained ankle), fracture or lower limb surgery in the last three months. Any disease (vestibular problem, vision and hearing disorders, etc.) that affects a person's balance People who have a history of high blood pressure, blood clotting disease, peripheral vascular disease, cardiovascular problems or diabetes People with internal prosthesis, acute disc herniation, recent fracture, joint inflammation, recent stroke, having an artificial pacemaker, epilepsy, migraine, peripheral neuropathy, pregnancy and malignancy. M25.373 Other instability, unspecified ankle Rehabilitation Rehabilitation Intervention group: Blood flow restriction combined with whole body vibration using whole body vibration device and blood flow restriction device for a single treatment session for 6 minutes. Control group: Whole body vibration alone Reaching distance in star excursion balance test. Timepoint: Before the intervention and immediately after the intervention. Method of measurement: tape measure. Number of errors in balance error scoring system. Timepoint: Before the intervention and immediately after the intervention. Method of measurement: Balance scoring system. Ankle joint repositioning error. Timepoint: Before the intervention and immediately after the intervention. Method of measurement: Using a goniometer and calculating the angle in AutoCAD software. Time Score in side hop test. Timepoint: Before the intervention and immediately after the intervention. Method of measurement: digital chronometer. Dorsiflexion range of motion. Timepoint: Before the intervention and immediately after the intervention. Method of measurement: goniometer. Rate of perceived instability. Timepoint: Before the intervention and immediately after the intervention. Method of measurement: visual analog scale. Tehran University of Medical Sciences Approved 2023-02-01 Ethics Committees of School of Nursing and Midwifery & Rehabilitation - Tehran University o Faculty of Rehabilitation , corner of Safi Alishah St.,Enqelab St., Tehran town tehran Tehran Iran (Islamic Republic of)