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IRCT20210604051488N1 IRCT 2021-06-28 Tehran University of Medical Sciences Effect of transcranial direct current stimulation in patients with chronic ankle instability Effect of balance training combined with transcranial direct current stimulation on preparatory brain activity in patients with chronic ankle instability 2021-07-06 anticipated 46 Complete https://irct.ir/trial/56754 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: After the baseline session, subjects were randomly allocated into groups using a balanced block randomization scheme (block size, 4) using a list randomizer from randomization.com.Sealed and coded envelopes used for concealment, which are provided to the participants by the secretary, Blinding description: All participants also blind to the sham and active applications of the a-tDCS and also to the grouping. In the sham group, the stimulator turn off after 30 s of stimulation without the participant’s knowledge. The a-tDCS or sham protocol was load into the software for each participant by study staff uninvolved in any other aspects of study. Then the same third party who coded the data into SPSS. N/A Chronic ankle instability. Intervention 1: Intervention group: Participants give 4-wk intervention of anodal transcranial direct current stimulation (aTDCS) with balance exercise. The exercises consist of Gastrocnemius and Soleus stretching; strengthening involved Thera-Band resistance Dorsiflexion, Plantar flexion, Inversion, Eversion; Neuromuscular control exercises involved Single-limb stance while kicking and single-limb–stance activities with eyes open and closed and Single-limb stance with ball toss; Progressive Balance Program consist of single-limb hops to stabilization ,hop to stabilization and reach. Exercises have difficulty levels and progress. Anodal transcranial direct current stimulation is applied using Medina Teb Gostar's neurostim 2 device and The skin and scalp assess for irritationor lesions before being cleaned with an alcohol pad. Two 4*4 cm sponge electrodes were saturated with 0.09 NaCl, and rubber electrodes corresponding to the TDCS anode and cathode were placed within the sponges. The anode sponge was placed at the location of Cz, whereas the cathode sponge was placed over the forehead. The stimulator set to provide 1.5 mA over 20 min. At the beginning of the current, we will have a 30-second period of ramping up current to reach the planned maximum intensity, which is considered here at 1.5 Amp. At the end of the current, we will have a 30-second ramping down period, which will gradually reduce the current and the device will turn off. Intervention 2: Control group: Participants give 4-wk intervention of sham transcranial direct current stimulation (aTDCS) with balance exercise. The exercises consist of Gastrocnemius and Soleus stretching; strengthening involved Thera-Band resistance Dorsiflexion, Plantar flexion, Inversion, Eversion; Neuromuscular control exercises involved Single-limb stance while kicking and single-limb–stance activities with eyes open and closed and Single-limb stance with ball toss; Progressive Balance Program consist of single-limb hops to stabilization ,hop to stabilization and reach. Exercises have difficulty levels and progress. Anodal transcranial direct current stimulation is applied using Medina Teb Gostar's neurostim 2 device and The skin and scalp assess for irritationor lesions before being cleaned with an alcohol pad. Two 4*4 cm sponge electrodes were saturated with 0.09 NaCl, and rubber electrodes corresponding to the TDCS anode and cathode were placed within the sponges. The anode sponge was placed at the location of Cz, whereas the cathode sponge was placed over the forehead. The stimulator set to provide 1.5 mA over 20 min. At the beginning of the current, we will have a 30-second period of ramping up current. the DC stimulator was turned off in 30 s after the initial ramping up of current. 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 I have not made a decision yet
public Roya Khanmohammadi
Tehran, District 12, Enghelab Street , Pich-E-Shemiran
Tehran Iran (Islamic Republic of) 6511111489 +98 21 7753 4133 Rkhanmohammadi@sina.tums.ac.ir Tehran University of Medical Sciences scientific Roya Khanmohammadi
Tehran, District 12, Enghelab Street , Pich-E-Shemiran
Tehran Iran (Islamic Republic of) 6511111489 +98 21 7753 4133 Rkhanmohammadi@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) The initial unilateral ankle sprain must have occurred at least 12 months prior to study enrollment The most recent injury must have occurred more than 3 months prior to study enrollment Episodes of giving way or feeling of instability in the involved ankle History of inflammation symptoms such as swelling, weakness, pain within the past year Cumberland Ankle Instability Tool (CAIT) score less than 24 Acquiring a score < 90% in daily living activities and < 80% in sport activities from foot and ankle ability measure (FAAM) questionnaire People in the age range of 18 to 35 years 18 years 35 years Both Evidence of neurological or psychiatric disorders, seizure and epilepsy, had a head injury resulting in a loss of consciousness, history of migraines History of ankle and lower limb surgery or fracture Pregnant Have any metallic implants, including intracranial electrodes,surgical clips, shrapnel or pacemaker S93.4 Sprain of ankle Rehabilitation Rehabilitation Intervention group: Participants give 4-wk intervention of anodal transcranial direct current stimulation (aTDCS) with balance exercise. The exercises consist of Gastrocnemius and Soleus stretching; strengthening involved Thera-Band resistance Dorsiflexion, Plantar flexion, Inversion, Eversion; Neuromuscular control exercises involved Single-limb stance while kicking and single-limb–stance activities with eyes open and closed and Single-limb stance with ball toss; Progressive Balance Program consist of single-limb hops to stabilization ,hop to stabilization and reach. Exercises have difficulty levels and progress. Anodal transcranial direct current stimulation is applied using Medina Teb Gostar's neurostim 2 device and The skin and scalp assess for irritationor lesions before being cleaned with an alcohol pad. Two 4*4 cm sponge electrodes were saturated with 0.09 NaCl, and rubber electrodes corresponding to the TDCS anode and cathode were placed within the sponges. The anode sponge was placed at the location of Cz, whereas the cathode sponge was placed over the forehead. The stimulator set to provide 1.5 mA over 20 min. At the beginning of the current, we will have a 30-second period of ramping up current to reach the planned maximum intensity, which is considered here at 1.5 Amp. At the end of the current, we will have a 30-second ramping down period, which will gradually reduce the current and the device will turn off. Control group: Participants give 4-wk intervention of sham transcranial direct current stimulation (aTDCS) with balance exercise. The exercises consist of Gastrocnemius and Soleus stretching; strengthening involved Thera-Band resistance Dorsiflexion, Plantar flexion, Inversion, Eversion; Neuromuscular control exercises involved Single-limb stance while kicking and single-limb–stance activities with eyes open and closed and Single-limb stance with ball toss; Progressive Balance Program consist of single-limb hops to stabilization ,hop to stabilization and reach. Exercises have difficulty levels and progress. Anodal transcranial direct current stimulation is applied using Medina Teb Gostar's neurostim 2 device and The skin and scalp assess for irritationor lesions before being cleaned with an alcohol pad. Two 4*4 cm sponge electrodes were saturated with 0.09 NaCl, and rubber electrodes corresponding to the TDCS anode and cathode were placed within the sponges. The anode sponge was placed at the location of Cz, whereas the cathode sponge was placed over the forehead. The stimulator set to provide 1.5 mA over 20 min. At the beginning of the current, we will have a 30-second period of ramping up current. the DC stimulator was turned off in 30 s after the initial ramping up of current. Peak Amplitude of Contingent Negative Variation (CNV) ; CNV is an event-dependent potential that is recorded using the warning-stimulus-response-motor response paradigm. In fact, CNV is a slow negative shift in the electroencephalographic wave amplitude between the two warning stimuli and the response stimulus, which is calculated by averaging the electroencephalographic wave in the time interval between the warning stimulus and the response stimulus. Timepoint: In the first evaluation session (before the intervention) and 48 hours after the last treatment session. Method of measurement: Using a 64-channel electroencephalography device(Micromed). Time of Peak Amplitude of CNV; CNV is an event-dependent potential that is recorded using the warning-stimulus-response-motor response paradigm. In fact, CNV is a slow negative shift in the electroencephalographic wave amplitude between the two warning stimuli and the response stimulus, which is calculated by averaging the electroencephalographic wave in the time interval between the warning stimulus and the response stimulus. Timepoint: In the first evaluation session (before the intervention) and 48 hours after the last treatment session. Method of measurement: Using a 64-channel electroencephalography device(Micromed). Amplitude of Late CNV; CNV is a slow negative shift in the electroencephalographic wave amplitude between the two warning stimuli and the response stimulus, which is calculated by averaging the electroencephalographic wave in the time interval between the warning stimulus and the response stimulus. It has two components, late and early. The early component reflects the perceptual processes and attention, and the late component represents the prediction and preparation of the brain to start moving. Timepoint: In the first evaluation session (before the intervention) and 48 hours after the last treatment session. Method of measurement: Using a 64-channel electroencephalography device(Micromed). Alpha event-related desynchronization (ERD) ; ERD is actually the frequency reduction in the beta and alpha bands, which begins about 2 to 1.5 seconds before the start of motion. The value of ERD at alpha and beta frequencies expresses the degree of cortical excitability. The larger the beta / alpha ERD, the higher the cortical excitability. In fact, ERD reflects the activity of motor areas along with the weakening of sensory afferents during movement. Alpha and beta band activity demonstrates brain preparation and brain planning. Timepoint: In the first evaluation session (before the intervention) and 48 hours after the last treatment session. Method of measurement: Using a 64-channel electroencephalography device (Micromed). Beta event-related desynchronization (ERD) ; ERD is actually the frequency reduction in the beta and alpha bands, which begins about 2 to 1.5 seconds before the start of motion. The value of ERD at alpha and beta frequencies expresses the degree of cortical excitability. The larger the beta / alpha ERD, the higher the cortical excitability. In fact, ERD reflects the activity of motor areas along with the weakening of sensory afferents during movement. Alpha and beta band activity demonstrates brain preparation and brain planning. Timepoint: In the first evaluation session (before the intervention) and 48 hours after the last treatment session. Method of measurement: Using a 64-channel electroencephalography device (Micromed). Star Excursion Balance Test ; This test is used for clinical evaluation. In other words, the maximum range of motion of the person standing on one leg stimulates the opposite leg in the posterolateral, posteromedial, and anterior direction. Timepoint: In the first evaluation session (before the intervention) and 48 hours after the last treatment session. Method of measurement: Strip Meter. The foot and ankle ability measure questionnaire (FAAM) score ; This questionnaire consists of 29 questions that are divided into two parts ADL and Sport, which includes 21 and 8 items, respectively, and 5 answers are considered for each question and its total score is reported as a percentage. The higher percentage show higher performance. Timepoint: In the first evaluation session (before the intervention) and 48 hours after the last treatment session. Method of measurement: The foot and ankle ability measure questionnaire (FAAM). The Cumberland Ankle Instability Tool's score; This questionnaire consists of 9 questions, the total score of which is 30, which indicates a high stability in the ankle. The Persian version of the Cumberland Ankle Instability Questionnaire can be used as a reliable tool to diagnose instability and measure changes due to therapeutic interventions in athletes with functional ankle instability. Timepoint: In the first evaluation session (before the intervention) and 48 hours after the last treatment session. Method of measurement: The Cumberland Ankle Instability Tool. Tehran University of Medical Sciences Approved 2021-04-26 School of Nursing and Midwifery and School of Rehabilitation - Tehran University of Medical Sciences Research and Technology Affairs Department, Room 605, 6th Floor, Tehran University of Medical Sciences Headquarters Building, Intersection of Keshavarz Boulevard and Ghods Street Tehran Tehran Iran (Islamic Republic of)