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IRCT20251109067922N1 IRCT 2025-11-11 Mashhad University of Medical Sciences Effects of Muscle Biofeedback and Mechanical Skin Stimulation of the Hand on Improving Hand Function in Children with Hemiplegic Cerebral Palsy Studying the effect of using biofeedback based on processing of electrical muscle activity and mechanical stimulation of hand skin mechanoreceptors on hand function in children with cerebral palsy of the torso 2025-11-11 anticipated 5 Complete https://irct.ir/trial/87353 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive. 2 Hemiplegic Cerebral Palsy. Intervention group: This study is conducted at Ghaem Hospital, Mashhad, in a quiet room of the Children's Rehabilitation Clinic, utilizing a single-group design. During 15 sessions of bimanual motor-cognitive games, wrist EMG recording and tactile feedback are provided via a vibrator on the palmar skin. Spasticity is assessed with the Ashworth scale and hand motor function with the Fogel-Meier test before and after the intervention, and changes are examined with appropriate statistical tests.. 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 Due to limitations related to initial consents and a commitment to maintaining participant confidentiality, no decision has been made at this time to share non-identifiable personal data.
public Hamideh Azizi
Opposite Shahid Kaveh 14, Shahid Kaveh Blvd., Mashhad, Khorasan Razavi, IRAN
Mashhad Iran (Islamic Republic of) 9186472607 +98 991 371 0614 drazizi1375@gmail.com Mashhad University of Medical Sciences scientific Hamideh Azizi
Opposite Shahid Kaveh 14, Shahid Kaveh Blvd., Mashhad, Khorasan Razavi, IRAN
Mashhad Iran (Islamic Republic of) 9186472607 +98 991 371 0614 drazizi1375@gmail.com Mashhad University of Medical Sciences Iran (Islamic Republic of) clinically confirmed diagnosis of hemiparetic cerebral palsy by a pediatric neurologist or pediatric specialist. Gross Motor Function Classification System (GMFCS) level I–II (mild to moderate impairment); children with levels III or higher are excluded. Age between 5 and 12 years. Ability to understand and follow experimental instructions (no severe cognitive or behavioral impairments). Absence of significant visual or hearing impairments that would interfere with performing motor-cognitive tasks. No orthopedic abnormalities (e.g., structural or range-of-motion limitations in the wrist or fingers) that would prevent participation in the exercises. 5 years 12 years Both Diagnosis of bilateral or quadriplegic cerebral palsy by a specialist physician. Gross Motor Function Classification System (GMFCS) level III or higher. Age below 5 years or above 12 years. Severe cognitive or behavioral impairment preventing instruction following. Severe visual impairment is hindering motor-cognitive task performance. Severe hearing impairment affects interaction with the game and feedback. Structural orthopedic abnormalities or limited wrist/finger range of motion. Lack of written informed consent from the child’s legal guardian. G80.2 Spastic hemiplegic cerebral palsy Rehabilitation Intervention group: This study is conducted at Ghaem Hospital, Mashhad, in a quiet room of the Children's Rehabilitation Clinic, utilizing a single-group design. During 15 sessions of bimanual motor-cognitive games, wrist EMG recording and tactile feedback are provided via a vibrator on the palmar skin. Spasticity is assessed with the Ashworth scale and hand motor function with the Fogel-Meier test before and after the intervention, and changes are examined with appropriate statistical tests. Wrist Spasticity. Timepoint: It will be conducted once before the interventions and once after the completion of the intervention sessions. Method of measurement: Wrist Spasticity Score. Hand Motor Function. Timepoint: It will be conducted once before the interventions and once after the completion of the intervention sessions. Method of measurement: Fugl-Meyer Assessment. Mashhad University of Medical Sciences Approved 2024-11-26 Ethics Committee of Mashhad University of Medical Sciences Central Organization of Mashhad University of Medical Sciences, Danesh and Salamat Town, between Shahid Al-Shehidi Square and Shahid Javan Square, at the end of Shahid Fakouri Boulevard. Mashhad Razavi Khorasan Iran (Islamic Republic of)