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IRCT20140222016680N9 IRCT 2022-10-08 Iran University of Medical Sciences The effect of transcranial direct current stimulation on upper limb motor function in stroke patients The effect of the combined Transcranial Direct Current Stimulation with Task- Oriented Training on Electroencephalographic Biomarkers and involved upper limb motor function in hemiparesis post stroke 2022-10-30 anticipated 36 Complete https://irct.ir/trial/66101 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random blocks (permuted block randomization) with four blocks will be used for randomization. According to the sample size of 36, 18 blocks will be generated using the online site (www.sealedenvelope.com). For concealment in the randomization process, a unique code will be used on each envelope with the type of training specified inside. Stratification will be used in order to have the same distribution in terms of the affected side (right or left hemiplegia) in two groups, Blinding description: In this study, َََََََََََََََََAssessor who evaluates the outcome measures of the survey will be blind to the allocation of the two treatment groups. َAditionally the data also will be assessed by a person who is blind to the type of treatment and treatment of groups. N/A unilateral ischemic stroke. Intervention 1: Intervention group: In this group, transcranial Direct Current Stimulation (tDCs) along with Task-Oriented Training are given for three weeks, 5 sessions per week, and each session for 60 minutes (15 sessions in total). Real-tDCs will be delivered by an anode electrode on the affected hemisphere. Real tDCS lasted 20 min at 2 mA, with a 30s ramp up and 30s ramp down. The exercises include 15 task-oriented exercises focusing on active and active-assistive movements to increase the range of motion of the upper limbs, grasping skills, grasping and moving, and releasing objects. Required equipment, tDCs device, and training supplies include a table, chair, ball, stacking checkers, and playing cards. Intervention 2: Control group: In this group, transcranial Direct Current Stimulation (tDCs) along with task-oriented exercises are given for three weeks, 5 sessions per week, and each session for 60 minutes (15 sessions in total). Sham tDCs will be delivered by the anode electrode on the affected hemisphere for 20 minutes. Sham tDCS consists of a 30-s ramp up followed by a 30-s ramp down of the current and between these intervals, the intensity of the current will be zero. The exercises include 15 task-oriented exercises focusing on active and active-assistive movements to increase the range of motion of the upper limbs, grasping skills, grasping and moving, and releasing objects. Required equipment, tDCs device, and training supplies include tables, chairs, balls, backgammon pieces, and playing cards. 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 Shohreh Noorizadeh Dehkordi
School of Rehabilitation Sciences, Madadkaran Street, Shahnazari Street, Madar Square, Mirdamad, Tehran, Iran
Tehran Iran (Islamic Republic of) 15459-13487 +98 21 2222 7124 noorizadeh.sh@iums.ac.ir Iran University of Medical Sciences scientific Shohreh Noorizadeh Dehkordi
School of Rehabilitation Sciences, Madadkaran Street, Shahnazari Street, Madar Square, Mirdamad, Tehran, Iran
Tehran Iran (Islamic Republic of) 15459-13487 +98 21 2222 7124 noorizadeh.sh@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Having a first unilateral ischemic stroke as confirmed by the MRI or CT-Scan At least 6 months have passed since the unilateral stroke Having the ability to walk for at least 10 meter (with or without cane) Having motor dysfunction in upper limb with a degree of recovery equal or more than 4 according to the recovery stages of Brunnstrom Having a score equal or above 26 in the "Montreal Cognitive Assessment" 18 years 80 years Both Having moderate to severe depression (a score of 19 or higher on the "Beck depression scale") Received Botox in the previous 6 months (to enter the study, patients must not have received Botox in the past six months) Having a contracture in the wrist and fingers of the affected side Having other neurological disorders such as Parkinson, Multiple Sclerosis and etc. Having a thalamic stroke or central pain syndrome (Dejerine Roussy Syndrome) Pain in the affected shoulder (having a score of less than 12 based on the Pain Assessment section of the "Fugle-Meyer assessment" of the upper extremity) Using drugs that affect the central nervous system Having pace maker or other stimulation or ferromagnetic implants Having a history of Seizures in the last two years and taking anticonvulsant drugs during one month before the enrollment in the current study Pregnancy unwillingness and lack of cooperation to continue the treatment Having serious and persistent skin complications or sleep and concentration disorders due to stimulation with tDCs Not completing the treatment period or occurrence of an accident that affects the motor function or brain activity 163.9 Cerebral infarction, unspecified Rehabilitation Rehabilitation Intervention group: In this group, transcranial Direct Current Stimulation (tDCs) along with Task-Oriented Training are given for three weeks, 5 sessions per week, and each session for 60 minutes (15 sessions in total). Real-tDCs will be delivered by an anode electrode on the affected hemisphere. Real tDCS lasted 20 min at 2 mA, with a 30s ramp up and 30s ramp down. The exercises include 15 task-oriented exercises focusing on active and active-assistive movements to increase the range of motion of the upper limbs, grasping skills, grasping and moving, and releasing objects. Required equipment, tDCs device, and training supplies include a table, chair, ball, stacking checkers, and playing cards. Control group: In this group, transcranial Direct Current Stimulation (tDCs) along with task-oriented exercises are given for three weeks, 5 sessions per week, and each session for 60 minutes (15 sessions in total). Sham tDCs will be delivered by the anode electrode on the affected hemisphere for 20 minutes. Sham tDCS consists of a 30-s ramp up followed by a 30-s ramp down of the current and between these intervals, the intensity of the current will be zero. The exercises include 15 task-oriented exercises focusing on active and active-assistive movements to increase the range of motion of the upper limbs, grasping skills, grasping and moving, and releasing objects. Required equipment, tDCs device, and training supplies include tables, chairs, balls, backgammon pieces, and playing cards. Electroencephalography parameters include "Absolute power" and "Relative power" and "Average frequency" within each frequency subband (delta, theta, alpha, beta and gamma). Timepoint: before treatment, after treatment (15th session), and 3 months later. Method of measurement: EEG recording. Upper limb motor function ability by the "Wolf Motor Function Test". Timepoint: before treatment, after treatment (15th session), and 3 months later. Method of measurement: "Wolf Motor Function Test". Upper limb motor function by the upper extremity part of the "Fugl-Meyer Assessment". Timepoint: before treatment, after treatment (15th session), and 3 months later. Method of measurement: Upper Extremity part of the "Fugl-Meyer Assessment". Patient's ability to handle objects of different sizes, weights and shapes. Timepoint: before treatment, after treatment (15th session), and 3 months later. Method of measurement: "Action Research Arm Test". Iran University of Medical Sciences Approved 2022-02-23 Ethic committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemmat Expressway Tehran Tehran Iran (Islamic Republic of)