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IRCT20200604047650N1 IRCT 2020-08-09 Khoram-Abad University of Medical Sciences The effect of rehabilitation on stroke The effect of cognitive rehabilitation and non-invasive brain stimulation on cognitive abilities and daily living activities of patients after ischemic stroke 2020-07-15 anticipated 52 Complete https://irct.ir/trial/48962 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Using stratified block random sampling(regarding the hemogeneity of groups in terms of gender( female/ male) and the intensity of ischemia(mild/moderate)) and RehaCom software with transcranial direct current stimulation(tdcs), the will divide samples to two intervention and sham groups. In fact, considering the gender and the intensity of ischemia( mild/ moderate), 4 strata will be formed in each of them four block random sampling will be used to assign patients to two intervention group and sham group.To this aim, first the researcher will write a list of blocks and assign number them (AABB-ABAB-BBAA-BABA-BAAB) the using random number table, the researcher will randomly select numbers between 1 to 6, and in this way, she will be provided with a list of treatment assignment, based on a sequence of letters A and B, Blinding description: This study will be double blind that is participants and data analysts will be blinded. Participants will all be willing to participate in the study but will not know whether they will be included in the intervention group or the sham one. group members will be fed into the statistical software with a code. Therefore data analyzer will not know to which group the extracted data will belong. Therefore, it will be a double blind study. N/A Cognitive disorders due to cerebral infarction. Intervention 1: Intervention group: In the intervention group, the researcher uses two methods of non-invasive electrical stimulation intervention and Rehacom rehabilitation software. After the patient is seated in a comfortable chair, where the monitor is in front of him and he has access to the software's keyboard, he is assured of support and support during rehabilitation. Anode and cathode electrodes are placed on the patient's head based on the location of the 10-20 system. The patient is then evaluated by RehaCom software. Based on the results of the evaluation and based on the software proposal, the desired modules are performed with emphasis on the executive functions for the patient. It should be noted that 30 seconds before the start of rehabilitation, the tdcs device is turned on and the stimulation is applied to the patient's scalp in the dorsolateral prefrontal cortex(F3) area through the anode electrode and continues for 20 minutes. It should be noted that while performing brain stimulation, the person is performing cognitive exercises of RehaCom software. Generally, intervention phase will last 12 sessions, 3 sessions a week. Intervention 2: Control group: In the current study, RehaCom's rehabilitation software and non invaisive brain stimulation (TDCS) device will also be used for the sham group. In fact, in the sham group, 30 seconds before starting the rehabilitation with RehaCom software, after placing electrodes on the skull, the TDCS will be switched on and the stimulatin will be applied at a voltage of 2 MA just like that in the intervention group. The only point of difference is that after 30 seconds and simultaneous with the onset of the cognitive rehabilitation the device automatically will shut off. However the rehabilitation will continue using RehaCom. It should be noted that the intervention will last 12 session, 3 sessions a week. Moreover, the group in which the TDCS divice will automatically shut off after 30 seconds is called the sham group. No - There is not a plan to make this available Justification or reason for not sharing IPD is As a legal entity, Lorestan University of Medical Sciences owns the data, and as an independent researcher, I do not have the right to publish any data. By obtaining legal permits from Lorestan University of Medical Sciences, information can be provided to others if needed.
public Negin Kordestani
Shahid Kiani Alley, Farzanegan 1 Alley, Naser khosro St, Khorram abad
Khorramabad Iran (Islamic Republic of) 6814955373 +98 66 3321 3531 kordestaninegin@gmail.com Khoram-Abad University of Medical Sciences scientific parastou kordestani maghaddam
Nursing and midwifery school, Lorestan University of Medical Sciences, 4 km of Khorramabad-Boroujerd road, Kamalvand, Khorramabad
Khorramabad Iran (Islamic Republic of) 381251698 +98 66 3312 0140 kparastou@yahoo.com Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) Age 40 to 65 years Have a minimum of literacy Patients diagnosed with ischemic stroke in the last three months Ischemia of the right hemisphere of the brain Get a score of less than 24 on a Mini-mental state examination Score between 15-1 in Modified national of health stroke scale 40 years 65 years Both Disruption of delicate balance movements, especially the right hand Having implantable metal objects (pacemakers, implants, brain clips, etc.) Taking antidepressants, anticonvulsants, hypnotics and muscle relaxants History of previous cerebral ischemic stroke Motor impairment and subsequent inability to visit the clinic G46.8 Other vascular syndromes of brain in cerebrovascular diseases Rehabilitation Placebo Intervention group: In the intervention group, the researcher uses two methods of non-invasive electrical stimulation intervention and Rehacom rehabilitation software. After the patient is seated in a comfortable chair, where the monitor is in front of him and he has access to the software's keyboard, he is assured of support and support during rehabilitation. Anode and cathode electrodes are placed on the patient's head based on the location of the 10-20 system. The patient is then evaluated by RehaCom software. Based on the results of the evaluation and based on the software proposal, the desired modules are performed with emphasis on the executive functions for the patient. It should be noted that 30 seconds before the start of rehabilitation, the tdcs device is turned on and the stimulation is applied to the patient's scalp in the dorsolateral prefrontal cortex(F3) area through the anode electrode and continues for 20 minutes. It should be noted that while performing brain stimulation, the person is performing cognitive exercises of RehaCom software. Generally, intervention phase will last 12 sessions, 3 sessions a week Control group: In the current study, RehaCom's rehabilitation software and non invaisive brain stimulation (TDCS) device will also be used for the sham group. In fact, in the sham group, 30 seconds before starting the rehabilitation with RehaCom software, after placing electrodes on the skull, the TDCS will be switched on and the stimulatin will be applied at a voltage of 2 MA just like that in the intervention group. The only point of difference is that after 30 seconds and simultaneous with the onset of the cognitive rehabilitation the device automatically will shut off. However the rehabilitation will continue using RehaCom. It should be noted that the intervention will last 12 session, 3 sessions a week. Moreover, the group in which the TDCS divice will automatically shut off after 30 seconds is called the sham group. Cognitive functions. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: Cognitive evaluation( attention and concentration, visual memory, reactive behavior, and logical thinking) by Rehacom software screening test scale. Basic activity of daily living, Advance activity of daily living. Timepoint: before intervention and 4 weeks after intervention. Method of measurement: Barthel index, Lawton Index. Khoram-Abad University of Medical Sciences Approved 2020-06-06 Ethics committee of Lorestan university of medical sciences Nursing and midwifery faculty, Lorestan medical sciences university, 4 kilometers of Khorramabad- Boroujerd road, Khorramabad khorramabad Lorestan Iran (Islamic Republic of)