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IRCT20230208057352N1 IRCT 2023-02-20 Tehran University of Medical Sciences Effects of Transcranial Direct Current Stimulation (tDCS) in Males with Chronic Ankle Instability (CAI) Effects of Transcranial Direct Current Stimulation (tDCS) on Clinical Symptoms and Neurocognitive Function in Males with Chronic Ankle Instability (CAI) 2023-02-20 anticipated 20 Complete https://irct.ir/trial/68468 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done using Random Allocation Software and based on the random block method with a block size of 4 and with an allocation ratio of 1:1, Blinding description: This study is a single-blind study and in fact, the participants do not know which group they are in (experimental or control). Of course, before entering the study, the participants will be informed in a consent form that they may be placed in one of the two experimental or control groups, but they will not be informed of which group they will enter. The experimental group will receive real anodal tDCS and the control group will receive sham current, and in the sham group the current will be cut off without the knowledge of the participants after 30 seconds. N/A Chronic Ankle Instability. Intervention 1: Intervention group: In this group, anodal transcranial direct current stimulation (tDCS) and exercises are used. Sessions are held 3 days a week for 4 weeks (12 sessions in total) and the duration of each session is estimated to be around 40 minutes. tDCS is applied using the Neurostim2 device of Medinateb Gostar company. Electrodes are placed in a sponge soaked with sterile salt (%0.09 NaCl). The active electrode (anode) is placed on M1 on the opposite side of the involved leg (C3 in cases of right ankle involvement and C4 in cases of left ankle involvement, according to the International 10-20 system). We place the reference electrode (cathode) over the forehead area on the side of the involved wrist. Anodal current is applied with an intensity of 2 mA and for 20 minutes. At first, the current is gradually increased for 30 seconds (ramp up) until it reaches 2 milliamps. During the entire stimulation time, we monitor the person for safety. In the end, the current is reduced for 30 seconds (ramp down) until it reaches zero. After applying tDCS, participants will perform progressive strength and balance exercises. Strength exercises using Thera-band are performed in 4 directions: plantar flexion, dorsiflexion, inversion, and eversion. The movements should be performed in 3 sets with 10 reps in each direction. Every three sessions, the exercises will progress and the Thera-band with more resistance will be used. Single-leg stance exercises are performed in 3 repetitions and 2 positions with eyes open and closed. Each activity (eyes open and closed) has 7 levels of difficulty. The exercise will progress to the next level whenever the participant can do 3 repetitions without errors. Intervention 2: Control group: In the control group, the same exercises are performed as in the intervention group. Also, in this group, tDCS is used with the same electrode placement as the intervention group, but the current is only maintained for 30 seconds and then it stops (sham). Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: Access period starts 3 months after the articles are published To whom: For researchers working in academic, scientific, and hospital institutions and clinicians Conditions: Researchers working in the field of neuroscience and rehabilitation of musculoskeletal disorders Where to obtain: Applicants for documentation can contact Sara Asadi Abadi via email. s-asadiabadi@razi.tums.ac.ir How to obtain: After receiving the request and stating the reasons for the need for the data, the request will be answered within a maximum period of one month Comments:
public Sara Asadi Abadi
School of Rehabilitation, Piche-Shemiran, Enghelab Ave.
Tehran Iran (Islamic Republic of) 1148965111 00 21 77528468 s-asadiabadi@razi.tums.ac.ir Tehran University of Medical Sciences scientific Azadeh Shadmehr
School of Rehabilitation, Piche-Shemiran, Enghelab Ave.
Tehran Iran (Islamic Republic of) 1148965111 +98 21 7752 8468 Shadmehr@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Males, 18-40 yrs; with a history of at least 1 significant ankle sprain (associated with pain, swelling, and/or dislocation) occurred at least 12 months prior to study enrollment Participants should report at least 2 episodes of giving way in the 6 months prior to study enrollment Cumberland Ankle Instability Tool (CAIT) score ≤ 24. Foot and Ankle Ability Measure (FAAM): ADL subscale <90%, Sports subscale <80% No pain in involved ankle Participants should be right-handed Instability should be unilateral 18 years 40 years Male Neurologic or orthopedic disorders wich may cause balance impairments History of lower extremity fracture or lower-extremity surgery Uncorrected hearing or visual impairments Have any metallic implants, pacemakers, intracranial electrodes, surgical clips A history of migraines, seizure, or head injury resulting in a loss of consciousness If contact with the scalp is not possible Have a scalp or skin condition (e.g., psoriasis or eczema) Using medications that may alter seizure threshold or cognitive performance If participants consume alcohol or caffeine 12 hours before the sessions M24.2 Instability secondary to old ligament injury Rehabilitation Rehabilitation Intervention group: In this group, anodal transcranial direct current stimulation (tDCS) and exercises are used. Sessions are held 3 days a week for 4 weeks (12 sessions in total) and the duration of each session is estimated to be around 40 minutes. tDCS is applied using the Neurostim2 device of Medinateb Gostar company. Electrodes are placed in a sponge soaked with sterile salt (%0.09 NaCl). The active electrode (anode) is placed on M1 on the opposite side of the involved leg (C3 in cases of right ankle involvement and C4 in cases of left ankle involvement, according to the International 10-20 system). We place the reference electrode (cathode) over the forehead area on the side of the involved wrist. Anodal current is applied with an intensity of 2 mA and for 20 minutes. At first, the current is gradually increased for 30 seconds (ramp up) until it reaches 2 milliamps. During the entire stimulation time, we monitor the person for safety. In the end, the current is reduced for 30 seconds (ramp down) until it reaches zero. After applying tDCS, participants will perform progressive strength and balance exercises. Strength exercises using Thera-band are performed in 4 directions: plantar flexion, dorsiflexion, inversion, and eversion. The movements should be performed in 3 sets with 10 reps in each direction. Every three sessions, the exercises will progress and the Thera-band with more resistance will be used. Single-leg stance exercises are performed in 3 repetitions and 2 positions with eyes open and closed. Each activity (eyes open and closed) has 7 levels of difficulty. The exercise will progress to the next level whenever the participant can do 3 repetitions without errors. Control group: In the control group, the same exercises are performed as in the intervention group. Also, in this group, tDCS is used with the same electrode placement as the intervention group, but the current is only maintained for 30 seconds and then it stops (sham) Visual choice reaction time. Timepoint: Before starting the intervention (the beginning of the first session) and after completion of 12 intervention sessions (the end of the last session). Method of measurement: Speed Anticipation Reaction Time Test (SART) software. Auditory choice reaction time. Timepoint: Before starting the intervention (the beginning of the first session) and after completion of 12 intervention sessions (the end of the last session). Method of measurement: SART software. Visual complex choice reaction time. Timepoint: Before starting the intervention (the beginning of the first session) and after completion of 12 intervention sessions (the end of the last session). Method of measurement: SART software. Auditory complex choice reaction time. Timepoint: Before starting the intervention (the beginning of the first session) and after completion of 12 intervention sessions (the end of the last session). Method of measurement: SART software. Low speed anticipation skill. Timepoint: Before starting the intervention (the beginning of the first session) and after completion of 12 intervention sessions (the end of the last session). Method of measurement: SART software. High speed anticipation skill. Timepoint: Before starting the intervention (the beginning of the first session) and after completion of 12 intervention sessions (the end of the last session). Method of measurement: SART software. Static balance: Foot-lift test. Timepoint: Before starting the intervention (the beginning of the first session) and after completion of 12 intervention sessions (the end of the last session). Method of measurement: Calculation of the average number of errors in three tests. Dynamic balance: Modified Star Excursion Balance Test. Timepoint: Before starting the intervention (the beginning of the first session) and after completion of 12 intervention sessions (the end of the last session). Method of measurement: Tape measure. Single-leg side-hop test. Timepoint: Before starting the intervention (the beginning of the first session) and after completion of 12 intervention sessions (the end of the last session). Method of measurement: Stopwatch. The Cumberland Ankle Instability Tool's score. Timepoint: Before starting the intervention, after the completion of 12 intervention sessions (end of the last session). Method of measurement: The Cumberland Ankle Instability Tool. The Foot and Ankle Ability Measure questionnaire (FAAM) score. Timepoint: Before starting the intervention, after the completion of 12 intervention sessions (end of the last session). Method of measurement: The Foot and Ankle Ability Measure questionnaire (FAAM). Tehran University of Medical Sciences Approved 2023-02-06 Research Ethics Committees of School of Nursing and Midwifery & Rehabilitation - Tehran University o School of Rehabilitation of Tehran University of Medical Sciences, Piche-Shemiran, Enghelab Ave. Tehran Tehran Iran (Islamic Republic of)