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IRCT20200914048720N1 IRCT 2020-10-13 Islamic Azad University Design and Effect of Biofeedback Model for Motor Rehabilitation Evaluation of the effectiveness of a biofeedback-based rehabilitation model based on muscle synergy model in upper limb mobility in patients with cerebral palsy due to stroke 2020-10-01 anticipated 24 Complete https://irct.ir/trial/50944 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: For the first time, it covers the challenge between clinical research and the engineering aspects of making biofeedback programs and can lead to the development of an efficient, inexpensive, and telemedicine method of rehabilitation, Randomization description: In this study, we use simple randomization models such as a Heads or Tails, using a random number table or using computer randomization methods and the Python program, and each client, for example, by dropping coins, head and tail in We put the intervention or control group, Blinding description: This study was divided into control and intervention groups. In this study, patients in both groups were evaluated before the intervention using inclusion criteria and main tests. Group 1: Regular physiotherapy exercises Group 2: Regular physiotherapy exercises plus 30 minutes of biofeedback-based training (intervention on the affected hand). The intervention is also performed as a double-blind randomized clinical trial. Blinding is for 3 groups of subjects, researchers and analysts. In this study, the evaluators (specialist physician, occupational therapist, and medical engineer) will be completely blind to the type of intervention and the group, because the tests will be evaluated by another team that is familiar with these tools. N/A Hemiplegia due to ischemic stroke in the middle cerebral artery. Intervention 1: Control group: Normal physiotherapy exercises Non-invasive movement exercises for adduction and abduction the arm. Intervention 2: Intervention group: In addition to the usual physiotherapy exercises, movement exercises such as adduction and abduction the arm based on visual feedback and biofeedback-based voice in 10 sessions for 30 minutes. Yes - There is a plan to make this available What will be shared: All information except recorded raw data will be shared from subjects after the defense and publication of articles. When: Access period starts 6 months after the publication of results and articles To whom: Students and researchers in the field of rehabilitation Conditions: Raw data is not available, but other results and documentation with reference to the source are not prohibited. Where to obtain: Seyyed Ali Zendehbad ali.zendebad@gmail.com How to obtain: Only valid university email and send ID card photo Comments: Be steadfast and victorious
public Athena Sharifi Razavi
Bu Ali Hospital (Avicenna Hospital),Pasdaran Boulevard, Sari, Mazandaran Province
Sari Iran (Islamic Republic of) 4815838477 +98 11 3334 3011 athena.sharifi@yahoo.com Mazandaran University of Medical Sciences scientific Seyyed Ali Zendehbad
Unit Five, Shemiran Building, Shahid Moghadam Far Alley, Pasdaran Boulevard, Sari, Mazandaran
Sari Iran (Islamic Republic of) 4814914711 +98 11 3334 7289 ali.zendebad@gmail.com Islamic Azad University Iran (Islamic Republic of) These Subjects should be Healthy and have no myopathic or anatomical problems Subjects must be right-handed subjects must not athletes 24 hours have passed since their stroke and they are in stable condition Patients should be in the acute phase The patients must be middle cerebral artery ischemic cerebral palsy Signing the patient's informed consent form 24 years no limit Both Cognitive problem Unstable clinical condition Vision problem hearing problem They will not be able to record signals and cooperate in research in the day Previous stroke history Problem of myopathy before stroke Hemorrhagic stroke Chronic phase Mental retardation G46.0 Middle cerebral artery syndrome Rehabilitation Rehabilitation Control group: Normal physiotherapy exercises Non-invasive movement exercises for adduction and abduction the arm Intervention group: In addition to the usual physiotherapy exercises, movement exercises such as adduction and abduction the arm based on visual feedback and biofeedback-based voice in 10 sessions for 30 minutes. Surface electromyogram signal analysis and motion analysis and the score of two Fugl-Meyer and NHISS tests will be used. Timepoint: 1 day after stroke, before intervention, 10 sessions after intervention. Method of measurement: 4-channel surface electromyography; Webcam recording; Questionnaires and clinical tests by a neurologist and physiotherapist. N/A Approved 2019-09-25 Ethics Committee of Mazandaran University of Medical Sciences Bu Ali Hospital (Avicenna Hospital),Pasdaran Boulevard, Sari, Mazandaran Province Sari Mazandaran Iran (Islamic Republic of)