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IRCT20170703034879N3 IRCT 2021-07-31 Tehran University of Medical Sciences Effect of transcranial direct current stimulation in diplegic cerebral palsy Clinical trial of transcranial direct current stimulation effect on gait in children with diplegic spastic cerebral palsy 2021-09-23 anticipated 20 Complete https://irct.ir/trial/57633 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment, Randomization description: We will use computer-generated randomization. Five blocks of 4 will be made by third party not involving in the study and randomization list will be generated. Neither investigator nor patients know the groups, Blinding description: A third party will make randomization list. The list will be given to investigator. Investigator, occupational therapist, outcome assessor and patients are blinded to the groups. After completion of study blinding will be removed. Data analyzer will not be blinded to the groups. N/A spastic diplegic Cerebral palsy. Intervention 1: Intervention group: In intervention group direct electrical stimulation is performed using saline wet sponge; anode is placed on cortical motor area Cz and cathode is placed on forehead. There will be 30 seconds of ascending direct current at the beginning, thereafter 20 minutes of stable 2 mA current and at the end 30 seconds of descending current will be employed. Intervention 2: . Intervention 3: Control group: In the sham group direct electrical stimulation is performed using saline wet sponge; anode is placed on cortical motor area Cz and cathode is placed on forehead. There will be 30 seconds of ascending direct current at the beginning, in the next 20 minutes no current is employed. Thereafter 30 seconds of descending current will be employed. Yes - There is a plan to make this available What will be shared: Deidentified IPD data collected for the primary and secondary outcomes will be available. When: Deidentified IPD data will be available 1 year after publication. To whom: Deidentified IPD data will be available for people working in academic institutions. Conditions: Request coming to principal investigator, will be evaluated. Requests that are to be used in review article or meta-analysis will be accepted. Where to obtain: Data request can reach the principal investigator through email; siamak.abdi@yahoo.com. Phone number +989363813113 can be used for text messages. How to obtain: Research ethics committee certificate is needed to be enclosed in the request email. Your email will be answered within a week. If you receive no answer within a week, another email as reminder is recommended. Comments:
public Dr Siamak Abdi
Neurology department, Shariati hospital, Jalal-e-Al-e-Ahmad Hwy
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 2224 Siamak.Abdi@yahoo.com Tehran University of Medical Sciences scientific Dr Siamak Abdi
Neurology department, Shariati hospital, Jalal-e-Al-e-Ahmad Hwy
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 2224 Siamak.Abdi@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Diplegic spastic cerebral palsy Gross Motor Function Classification System (GMFCS) less than 4, i.e. can walk independently or with walking aid age between 5 and 12 years 5 years 12 years Both patient or parents do not consent history of surgery in previous 12 months uncontrolled epilepsy metallic foreign body in brain orthopedic problem needing urgent surgery cognitive problem troubling cooperation G80.1 Spastic diplegic cerebral palsy Treatment - Devices Placebo Intervention group: In intervention group direct electrical stimulation is performed using saline wet sponge; anode is placed on cortical motor area Cz and cathode is placed on forehead. There will be 30 seconds of ascending direct current at the beginning, thereafter 20 minutes of stable 2 mA current and at the end 30 seconds of descending current will be employed. Control group: In the sham group direct electrical stimulation is performed using saline wet sponge; anode is placed on cortical motor area Cz and cathode is placed on forehead. There will be 30 seconds of ascending direct current at the beginning, in the next 20 minutes no current is employed. Thereafter 30 seconds of descending current will be employed. Velocity of gait. Timepoint: gait velocity will be measured 1 week after the completion of first and second course (after crossover) of tDCS. Method of measurement: Measured during gait analysis by velocity sensors. Cadence. Timepoint: cadence will be measured 1 week after the completion of first and second course (after crossover) of tDCS. Method of measurement: Measured during gait analysis by velocity and time sensors. PEDI : Pediatric evaluation of disability inventory. Timepoint: PEDI will be filled 1 week after the completion of first and second course (after crossover) of tDCS. Method of measurement: The investigator will fill the inventory. 6MWT: six minute walk test. Timepoint: 6MWT be measured 1 week after the completion of first and second course (after crossover) of tDCS. Method of measurement: The distance walked in 6 minutes will be measured by the investigator. Tehran University of Medical Sciences Approved 2021-06-27 Ethics committee of Tehran University of Medical Sciences Neurology department, Shariati Hospital, North Kargar Street Tehran Tehran Iran (Islamic Republic of)