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IRCT20230104057044N1 IRCT 2023-01-27 Semnan University of Medical Sciences Investigating the effect of tDCS on stroke Study the effect of cathodal tDCS on healthy side comparing with anodal tDCS on affected side of motor cortex on lower limb muscles spasticity in patients with stroke 2023-02-20 anticipated 45 Complete https://irct.ir/trial/67983 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The grouping method is a random grouping type in the block method where people are placed in three groups. The size of the used block is 3 and therefore, based on this, the combination of these modes for the control group and the patient groups, which are displayed with the letters C, T1 and T2 respectively, will include 6 modes. which will include (T2T1C, T1T2C, T1CT2, CT2T1, and CT1T2, T2CT1, ). The selection of blocks will be done randomly with the help of Excel software so that 15 blocks are randomly selected and therefore 45 samples can be included in the study in a random sequence that can be included in each control and treatment group. The number of blocks and how they are executed are done by hiding them inside the envelope. In this method, the blocks are numbered based on a random sequence and placed inside the envelopes, and the researcher assigns them to the intervention and treatment groups based on the order of arrival of the patients. N/A stroke. Intervention 1: Intervention group: cathodal. It includes ten sessions of routine stroke physiotherapy along with cathodal TDCS. In this study, the TDCS device (ActivaDose® II, ActivaTeK™ Inc., Gilroy, CA) will be used. The size of stimulation electrodes are 5 x 7 cm and are made of sponge soaked in salt solution. The anode (+) electrode will be placed on the un-affected area of ​​the brain and the reference electrode will be placed on the opposite circuit. In the cathodal group, cathodal TDCS with an intensity of 2 mA will be used for 20 minutes on the motor cortex of the un-affected side, and along with it, the contraction of the tibialis anterior muscle will be applied through functional electrical stimulation current (6 seconds of contraction and 12 seconds of rest). The duration of each physiotherapy session will be 40 minutes. In the first ten minutes, ankle plantar flexor muscle stretching exercises will be performed with 20 repetitions and each stretch for 20 seconds. Then, TDCS cathodal treatment will be used along with FES, and at the end, the patient will be given training on the postural correction , corrective and functional exercises, and balance exercises to perform exercises at home. Treatment sessions will be conducted in 5 sessions per week and for a total period of 2 weeks. Intervention 2: Intervention group: anodal. It includes ten sessions of routine stroke physiotherapy along with anodal TDCS. The device used and the size of the stimulation electrode in this group will be similar to the cathodal group. In this group, the anode (+) electrode will be placed on the affected area of ​​the brain and the reference electrode will be placed on the opposite circuit. In this group, anodal TDCS with an intensity of 2 mA will be applied for 20 minutes on the motor cortex of the affected side along with the contraction of the tibialis anterior muscle through functional electrical stimulation current (6 seconds of contraction and 12 seconds of rest). The duration of each session will be 30 minutes. In the first ten minutes, stretching exercises for the ankle plantar flexor muscles will be performed with 20 repetitions and each stretch for 20 seconds. Then TDCS anodal treatment along with FES will be used and at the end, the patient will be taught the correct position of the body, corrective and functional exercises and balance exercises to perform exercises at home. Treatment sessions will be conducted in 5 sessions per week and for a total period of 2 weeks. Intervention 3: Control group: In this group, ten routine stroke physiotherapy sessions will be performed. Routine physiotherapy includes maintaining the correct position of the body, stretching exercises, functional electrical stimulation current, physiotherapy techniques and exercise training. The FES current will be applied through two rubber adhesive electrodes of 5 cm2 size placed on the movement point of the tibialis anterior muscle. Active FES was set with a pulse length of 250 μs, a frequency of 50 Hz, and a stimulation period of 1:2 with active muscle contraction during 6 s. The total duration of the stimulation will be 20 minutes. The treatment sessions will be 5 sessions per week for a total period of 2 weeks. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals. When: The access period starts 6 months after the results are published To whom: The data of this study will be available only to researchers working in academic and scientific institutions. Conditions: The data of this study will be available for meta-analysis. Where to obtain: fatemehehsani59@yahoo.com How to obtain: In order to request the data of this study, it is necessary to send an official written request by e-mail and clearly explain the reason for the request. Comments:
public Fatemeh Ehsani
rehabilitation school of Semnan University of Medical Sciences
Semnan Iran (Islamic Republic of) 3513138111 +98 23 3365 4180 fatemehehsani59@yahoo.com Semnan University of Medical Sciences scientific Fatemeh Ehsani
rehabilitation school of Semnan University of Medical Sciences
Semnan Iran (Islamic Republic of) 3513138111 +98 23 3365 4180 fatemehehsani59@yahoo.com Semnan University of Medical Sciences Iran (Islamic Republic of) Stroke patients with an age range of 40 to 80 years At least 6 months have passed since the stroke No history of botulism injections or other invasive treatments in the past 6 months The minimum Ashworth score is 1. 40 years 80 years Both History of epilepsy History of cerebellar aneurysm Metal implants in the brain Widespread infection (all areas of the middle cerebral artery) Severe flaccid hemiplegia head injury Other neurological or orthopedic diseases that can affect motor function Renal or hepatic impairment Report of injection of previous painkillers Severe cognitive impairment The stroke areas involve both hemispheres I64 Stroke, not specified as haemorrhage or infarction Rehabilitation Rehabilitation Rehabilitation Intervention group: cathodal. It includes ten sessions of routine stroke physiotherapy along with cathodal TDCS. In this study, the TDCS device (ActivaDose® II, ActivaTeK™ Inc., Gilroy, CA) will be used. The size of stimulation electrodes are 5 x 7 cm and are made of sponge soaked in salt solution. The anode (+) electrode will be placed on the un-affected area of ​​the brain and the reference electrode will be placed on the opposite circuit. In the cathodal group, cathodal TDCS with an intensity of 2 mA will be used for 20 minutes on the motor cortex of the un-affected side, and along with it, the contraction of the tibialis anterior muscle will be applied through functional electrical stimulation current (6 seconds of contraction and 12 seconds of rest). The duration of each physiotherapy session will be 40 minutes. In the first ten minutes, ankle plantar flexor muscle stretching exercises will be performed with 20 repetitions and each stretch for 20 seconds. Then, TDCS cathodal treatment will be used along with FES, and at the end, the patient will be given training on the postural correction , corrective and functional exercises, and balance exercises to perform exercises at home. Treatment sessions will be conducted in 5 sessions per week and for a total period of 2 weeks. Intervention group: anodal. It includes ten sessions of routine stroke physiotherapy along with anodal TDCS. The device used and the size of the stimulation electrode in this group will be similar to the cathodal group. In this group, the anode (+) electrode will be placed on the affected area of ​​the brain and the reference electrode will be placed on the opposite circuit. In this group, anodal TDCS with an intensity of 2 mA will be applied for 20 minutes on the motor cortex of the affected side along with the contraction of the tibialis anterior muscle through functional electrical stimulation current (6 seconds of contraction and 12 seconds of rest). The duration of each session will be 30 minutes. In the first ten minutes, stretching exercises for the ankle plantar flexor muscles will be performed with 20 repetitions and each stretch for 20 seconds. Then TDCS anodal treatment along with FES will be used and at the end, the patient will be taught the correct position of the body, corrective and functional exercises and balance exercises to perform exercises at home. Treatment sessions will be conducted in 5 sessions per week and for a total period of 2 weeks. Control group: In this group, ten routine stroke physiotherapy sessions will be performed. Routine physiotherapy includes maintaining the correct position of the body, stretching exercises, functional electrical stimulation current, physiotherapy techniques and exercise training. The FES current will be applied through two rubber adhesive electrodes of 5 cm2 size placed on the movement point of the tibialis anterior muscle. Active FES was set with a pulse length of 250 μs, a frequency of 50 Hz, and a stimulation period of 1:2 with active muscle contraction during 6 s. The total duration of the stimulation will be 20 minutes. The treatment sessions will be 5 sessions per week for a total period of 2 weeks. The grade of spasticity in ankle plantar flexor muscles during active and passive ankle dorsiflexion. Timepoint: Before intervention, after the tenth session of the intervention, two weeks after the last session of the intervention. Method of measurement: Modified Ashworth scale and electromyography device. Balance. Timepoint: Before intervention, after the tenth session of the intervention, two weeks after the last session of the intervention. Method of measurement: Berg balance scale. Quality of life. Timepoint: Before intervention, after the tenth session of the intervention, two weeks after the last session of the intervention. Method of measurement: WHOQOL-BREF. Semnan University of Medical Sciences Approved 2022-12-26 Research Ethics Committee of Semnan University of Medical Sciences Treatment and Medical Education headquarters, Ministry of Health, between South Flamak and Zarafshan, Simai Iran St, Qods town Tehran Tehran Iran (Islamic Republic of)