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IRCT20201116049417N1 IRCT 2020-12-25 University of social welfare and rehabilitation sciences The combined rehabilitation at cerebral stroke The effect of combined rehabilitation based on visuo-perceptual and galvanic vestibular stimulation on balance function and brain waves of patients with right hemisphere ischemic stroke 2020-12-05 anticipated 48 Complete https://irct.ir/trial/52361 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, block randomization method was used for random allocation. The statistician designs 8 blocks of 6 (considering that we have 3 groups) using the "sealedenvelope.com" website. Blocking and allocation sequencing for concealment will be done by the person not involved in the research. The sample allocation ratio will be (Allocation 1: 1) and fall into three groups. Rehabilitation exercises will then be given to patients based on the obtained blocks and in the order of allocation sequence. N/A Right hemisphere ischemic stroke. Intervention 1: Intervention group: Sham vestibular galvanic stimulation for 20 minutes (providing stimulation at the beginning and turning off the stimulus), 2- Performing RCDM rehabilitation (perpendicularity of the line in the optokinetic field of view) for 20 minutes. This process is repeated during 20 sessions.Community Verified icon. Intervention 2: Intervention group: 1- Presenting galvanic vestibular stimulation for 20 minutes at the threshold level and 2- Performing RCDM (perpendicular line in the optokinetic field of view) rehabilitation for 20 minutes. This process is repeated during 20 sessions. Intervention 3: Control group: Stroke patients receiving conventional physiotherapy rehabilitation: According to studies, range of motion exercises related to the upper and lower limbs, weight lifting on the involved side, walking in parallel load forward and backward, pelvic bridging exercises and stretching exercises. Yes - There is a plan to make this available What will be shared: All potential data can be shared after de-identifying individuals. When: Access period starts 3 months after the results are published To whom: The data of this study will be available to researchers working in academic and scientific institutions. Conditions: Further analysis of the delivered data will be possible only with the coordination of the main researcher. Where to obtain: Applicants can submit their application by sending an email to the lead researcher. How to obtain: The request is first submitted to the principal investigator. The data is then sent to the applicant in coordination with other research colleagues and in determining the applicant's purpose. Comments:
public Meymaneh Jafari
Third Fl., No. 2, Khosrobeigi Aly., Mojdeh St. Hoseinabad Sq., HeraviSq.
Tehran Iran (Islamic Republic of) 1668844844 +98 21 2295 6308 meymaneh.jafari@gmail.com University of social welfare and rehabilitation sciences scientific Meymaneh Jafari
Third Fl., No. 2, Khosrobeigi Aly., Mojdeh St., Hoseinabad Sq., Heravi Sq.
Tehran Iran (Islamic Republic of) 1668844844 +98 21 2295 6308 meymaneh.jafari@gmail.com University of social welfare and rehabilitation sciences Iran (Islamic Republic of) Ischemic stroke for the first time Confirmation of right hemisphere stroke with clinical evaluation and MRI imaging Having a stroke more than 2 weeks and less than a year before the start of the study Ability to understand oral commands Awareness of self, place and time Difficulty in balance and walking Stable medical condition Ability to stand independently without assistance for at least 30 seconds Ability to walk with or without aid for at least 15 meters Good visual acuity with proper correction Right-handed Appropriate cognitive status and earning a minimum of 19 points using MMSE 40 years 60 years Both Cerebellar and orthopedic injuries Existence of neurological problems other than stroke The difference in the length of the two legs is more than 2 cm Use of drugs that impair vestibular function Peripheral vestibular disorders confirmed by VNG, vHIT and VEMP assessments History of BPPV Use of a heart pacemaker, metal brain implants, epilepsy or skin allergies behind the corners Recurrent strokes Any uncontrolled health condition in which assessments are prohibited I61.1 Nontraumatic intracerebral hemorrhage in hemisphere, cortical Rehabilitation Rehabilitation Rehabilitation Intervention group: Sham vestibular galvanic stimulation for 20 minutes (providing stimulation at the beginning and turning off the stimulus), 2- Performing RCDM rehabilitation (perpendicularity of the line in the optokinetic field of view) for 20 minutes. This process is repeated during 20 sessions.Community Verified icon Intervention group: 1- Presenting galvanic vestibular stimulation for 20 minutes at the threshold level and 2- Performing RCDM (perpendicular line in the optokinetic field of view) rehabilitation for 20 minutes. This process is repeated during 20 sessions. Control group: Stroke patients receiving conventional physiotherapy rehabilitation: According to studies, range of motion exercises related to the upper and lower limbs, weight lifting on the involved side, walking in parallel load forward and backward, pelvic bridging exercises and stretching exercises. Score of Balance Systems Assessment Questionnaire (BESTest). Timepoint: Before starting rehabilitation, Immediately after completion of rehabilitation, One month after the end of rehabilitation. Method of measurement: Using the BESTest questionnaire. Score of POMA Balance and Gait Evaluation Questionnaire. Timepoint: Before starting rehabilitation, Immediately after completion of rehabilitation, One month after the end of rehabilitation. Method of measurement: Using the POMA questionnaire. LOS range of motion. Timepoint: Before starting rehabilitation, Immediately after completion of rehabilitation, One month after the end of rehabilitation. Method of measurement: Using posturography. SOT composite score. Timepoint: Before starting rehabilitation, Immediately after completion of rehabilitation, One month after the end of rehabilitation. Method of measurement: Using posturography. Fixed error and absolute error of vertical vision perception (SVV). Timepoint: Before starting rehabilitation, Immediately after completion of rehabilitation, One month after the end of rehabilitation. Method of measurement: Using SVV test. DTABR and BSI in electroencephalography. Timepoint: Before starting rehabilitation, Immediately after completion of rehabilitation, One month after the end of rehabilitation. Method of measurement: Using Electroencephalography. University of social welfare and rehabilitation sciences Approved 2019-10-21 Ethics committe of University of Social Welfare and Rehabilitation Sciences Kodakyar Ave., Daneshjo Blvd., Evin (Velenjak) Tehran Tehran Iran (Islamic Republic of)