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IRCT20250624066242N3 IRCT 2026-05-14 Mashhad University of Medical Sciences Investigating of the changes in the functional and structural brain connectivities due to electromyographic biofeedback training related for hand grasping in hemiparetic children using processing of the EEG signals and the DTI images Investigating of the changes in the functional and structural brain connectivities due to electromyographic biofeedback training related for hand grasping in hemiparetic children using processing of the EEG signals and the DTI images 2026-05-19 anticipated 5 Recruiting https://irct.ir/trial/89173 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. N/A cerebral palsy. Intervention group: Children with unilateral cerebral palsy (spastic hemiplegia) will participate in therapeutic intervention sessions combined with electromyographic biofeedback and stimulation of hand cutaneous mechanoreceptors. Each patient will attend 10 training sessions. In each training session, the child will attempt, in the form of a game, to maintain the position of an object on the display screen. The most important feature of this motor–cognitive task is the requirement to use both hands. Moreover, the task will be designed in such a way that its execution resembles solving a multivariable problem, requiring the engagement of various cognitive processes such as attention, concentration, prediction, and related functions.. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after individuals are made unidentifiable. When: The course starts 6 months after the results are published. To whom: Will be available to researchers working in academic and scientific institutions Conditions: It is permissible to use the data provided that the source is acknowledged. Where to obtain: Javad Akhondian Yazdi, Akhondianj@mums.ac.ir How to obtain: First, Dr. Akhondian will be contacted by email or phone, and if approved, the necessary information will be provided. Comments:
public Javad Akhondian Yazdi
Ahmadabad Street
Mashhad Iran (Islamic Republic of) 9919991766 +98 51 3844 0350 Akhondianj@mums.ac.ir Mashhad University of Medical Sciences scientific Javad Akhondian Yazdi
Ahmadabad street
Mashhad Iran (Islamic Republic of) 9919991766 +98 51 3844 0350 Akhondianj@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Children with unilateral cerebral palsy or spastic hemiplegia will be selected based on a specialist diagnosis. Children over 5 years of age will be included in the study. 5 years 16 years Both If the patient's grade is determined to be severe based on criteria such as gross motor function, they will not be included in the study. Children with severe visual and hearing impairments will be excluded from the study. If children are unable to perform the task due to cognitive or behavioral impairments, they will be excluded from the study. If there are orthopedic defects in the hands that prevent the desired movement, the child will not be included in the study. G80.2 Spastic hemiplegic cerebral palsy Treatment - Devices Intervention group: Children with unilateral cerebral palsy (spastic hemiplegia) will participate in therapeutic intervention sessions combined with electromyographic biofeedback and stimulation of hand cutaneous mechanoreceptors. Each patient will attend 10 training sessions. In each training session, the child will attempt, in the form of a game, to maintain the position of an object on the display screen. The most important feature of this motor–cognitive task is the requirement to use both hands. Moreover, the task will be designed in such a way that its execution resembles solving a multivariable problem, requiring the engagement of various cognitive processes such as attention, concentration, prediction, and related functions. All hand movements. Timepoint: 3 months. Method of measurement: Fugl-Meyer Assessment and Ashworth test. The analysis of brain dynamic changes conducted using EEG signals and the evaluation of structural brain connectivity changes using DTI. For this purpose, five pediatric patients will be selected. After completing the intervention exercises, the effectiveness of the motor–cognitive training delivered through the device will be evaluated.The first assessment will be the Ashworth test, which measures the level of wrist muscle spasticity. Timepoint: Five patients, each undergoing 15 training sessions. Method of measurement: The level of wrist muscle spasticity will be assessed using the Ashworth test. The results will be obtained before the start of the intervention and after completion of the 15 sessions and will then be compared to determine the extent of improvement in cognitive and hand motor functions. The analysis of brain dynamic changes conducted using EEG signals and the evaluation of structural brain connectivity changes using DTI. For this purpose, five pediatric patients will be selected. In the next stage, the Fugl–Meyer Assessment will be used to evaluate hand motor function. Timepoint: Five patients, each undergoing 15 training sessions. Method of measurement: Fugl–Meyer Assessment of the upper extremity will be administered to evaluate motor abilities. The results will be obtained before the start of the intervention and after completion of the 15 sessions and will then be compared to determine the extent of improvement in cognitive and hand motor functions. Mashhad University of Medical Sciences Approved 2026-01-19 Faculty of Medicine, Mashhad University of Medical Sciences (Research Ethics Committee) Niloofar 3 Mashhad Razavi Khorasan Iran (Islamic Republic of)