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IRCT20210712051854N7 IRCT 2024-06-18 Tehran University of Medical Sciences Effect of Electrical Stimulation on ankle sprains Researching the efficacy of using Electrical Stimulation on the muscle changes caused by the immobility of the dominant leg due to ankle sprain 2024-05-20 anticipated 20 Complete https://irct.ir/trial/76671 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method is simple, in this way, we provide patients with 20 envelopes from numbers 1 to 20 so that neither the patient nor the evaluators know the order of the numbers, after the patients choose the envelopes, If the number inside the envelope is an odd number, the patient is placed in the Control group, and if the number is even, the patient is placed in the NMES group. N/A Dominant leg ankle sprain. Intervention 1: Intervention group: For individuals assigned to the NMES group, two NMES sessions were performed every day during 3 weeks of immobility at home. For this reason, the required NMES device in pocket sizes will be available to the participants during the study period. This device will work automatically and can be manually adjusted. The initial setting of this device will be done by the study team at the beginning of the installation. Neuromuscular electrical stimulation sessions will be done in the morning and afternoon with at least 4 hours between sessions. The NMES protocol consisted of a warm-up phase (5 min, 5 Hz, 250 μs), a stimulation period (30 min, 100 Hz, 400 μs, 5 s on) (0.75 s rise, 3.5 s contraction , 0.75 s fall) and 10 s off) and a cool-down phase (5 min, 5 Hz, 250 μs). Intervention 2: Control group: does not receive any type of intervention. 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 further information
public Samaneh Mohammadi
No. 126, Shahid Janmorad Bakhtiari, Former Shahrdari street
Hashtgerd Iran (Islamic Republic of) 3361764843 +98 26 4421 2974 samaneh.mohammadi1020@gmail.com Tehran University of Medical Sciences scientific Samaneh Mohammadi
No. 126, Shahid Janmorad Bakhtiari alley, former shahrdari street
Hashtgerd Iran (Islamic Republic of) 3361764843 +98 26 4421 2974 samaneh.mohammadi1020@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) The study subjects are the patients who go to the emergency room of the hospital due to ankle sprain and are candidates for brace implantation. no limit 40 years Both BMI lower than 18.5 or higher than 30 kg/m2; Any back, knee or shoulder complaints that may interfere with the use of crutches; Type 2 diabetes determined by HBAc1 >7.0% family history of thrombosis; severe heart problems; People who have done structured and long-term resistance training during the 6 months before the study; People with neurological, muscular problems or previous trauma to any of the organs that may in any way cause a difference in the function and strength of the muscles between the left and right lower limbs of the patients. Rehabilitation Rehabilitation Intervention group: For individuals assigned to the NMES group, two NMES sessions were performed every day during 3 weeks of immobility at home. For this reason, the required NMES device in pocket sizes will be available to the participants during the study period. This device will work automatically and can be manually adjusted. The initial setting of this device will be done by the study team at the beginning of the installation. Neuromuscular electrical stimulation sessions will be done in the morning and afternoon with at least 4 hours between sessions. The NMES protocol consisted of a warm-up phase (5 min, 5 Hz, 250 μs), a stimulation period (30 min, 100 Hz, 400 μs, 5 s on) (0.75 s rise, 3.5 s contraction , 0.75 s fall) and 10 s off) and a cool-down phase (5 min, 5 Hz, 250 μs). Control group: does not receive any type of intervention. Muscle cross-sectional area. Timepoint: Muscle cross-sectional area was measured at the beginning of the study (before the intervention) and 3 weeks after the intervention. Method of measurement: Measurement of muscle cross section was done by Magnetic resonance imaging. In order to ensure consistency of measurement of each muscle, the linear distances from the lateral knee joint line to the inferior point of the lateral malleolus, as well as the linear distance from the medial knee joint line to the inferior point of the medial malleolus were measured. From these measurements, the 30 and 50% distances from the knee joint line were determined and marked with a soft-tipped marker. Prior to entering the MRI machine, participants completed a safety screening, in the waiting room of the MRI facility fish oil tablets attached to a Velcro strap were placed at the previously measured markings of 30 and 50% of the shank length. upon completion, The fish oil tablets allowed the researchers to consistently locate the appropriate slices to measure at the correct location of the shank. A 3 Tesla magnet (TIM-Trio 3.0 T MRI, Siemens, Erlangen, Germany) was used to scan the left leg first, then the right leg. 30% shank length images were obtained first, followed by the 50% shank length image for each leg. Participants were lying supine and placed feet first into the magnet. The initial localizer scan was centered on the marked location being imaged. T1weighted MRI images were acquired using a Siemens sequence using an axial orientation, and an acquisition time of 20 s. The resolution was 1.56 mm by 1.95 mm with a slice thickness of 6 mm and a space between slices of 3 mm. The resolution matrix was 256 × 205. An8-channel knee coil was used to obtain a total of 10 images at each location. Repetition Time (TR)=7.3 ms and Echo Time (TE)=3.6 ms. The muscle strength of each leg. Timepoint: The muscle strength of each leg was measured at the beginning of the study (before the intervention) and 3 weeks after the intervention. Method of measurement: Assessment was done by hand held dynamometer . All experiments were performed with participants in the supine position with the hip and knee extended and the lower limb immobilized proximal to the ankle joint. Dynamometer against the dorsal surface of the foot just near the metatarsal heads for dorsiflexion, on the plantar surface just near the first metatarsal head for plantar flexion, on the medial side of the foot at the midpoint of the trunk of the first metatarsal for inversion, on the lateral side of the foot at the midpoint of the metatarsal The fifth was placed for eversion. To evaluate the smaller toes, the dynamometer was placed on the plantar surface of the toes. In people with smaller feet or toe deformities, there was not enough space for the device, and as a result, the smaller toes were forced to dorsiflexion. As a result, to standardize the test position, it was decided that at the maximum end range of dorsiflexion using The dynamometer should be tested for dorsiflexion of the fingers in the participant's comfortable range of motion. This technique was also used to evaluate hallux plantar flexion strength. Plasma glucose concentration. Timepoint: Plasma glucose concentration was measured at the beginning of the study (before the intervention). Method of measurement: During test day 1, fasting venous blood samples will be collected to determine basal plasma glucose and insulin concentrations. Blood (10 ml) will be collected in tubes containing EDTA and directly centrifuged at 1000 g for 10 minutes at 4°C. Large amounts of plasma were immediately frozen in liquid nitrogen and stored at -80°C until further analysis. Plasma glucose concentration will be analyzed. Plasma insulin concentration. Timepoint: Plasma insulin concentration was measured at the beginning of the study (before the intervention). Method of measurement: During test day 1, fasting venous blood samples will be collected to determine basal plasma glucose and insulin concentrations. Blood (10 ml) will be collected in tubes containing EDTA and directly centrifuged at 1000 g for 10 minutes at 4°C. Large amounts of plasma were immediately frozen in liquid nitrogen and stored at -80°C until further analysis. Plasma insulin concentration will also be determined. Tehran University of Medical Sciences Approved 2024-03-03 Research Ethics Committees of School of Medicine- Tehran University of Medical Sciences Building no.1, Northern gate of the university, Poursina St. Qods St. Enqelab St. Tehran Tehran Iran (Islamic Republic of)