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IRCT20231227060542N1 IRCT 2024-01-26 nil To determine the combined effects of trans-cranial direct current stimulation and mirror therapy on neuromuscular development and mental health in children with spastic quadriplegic cerebral palsy. TDCS, MT, CP Effects of trans-cranial direct current stimulation with and without mirror therapy on neuromuscular development and mental health in children with spastic quadriplegic cerebral palsy 2024-01-08 anticipated 105 Complete https://irct.ir/trial/74723 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Nil, Randomization description: Sampling technique will be simple random sampling and allocation to different groups will be via random number table. Subjects will be evaluated for eligibility before allocation to one of three groups: Group-A (TDCS, MT with routine Physical Therapy), Group-B (TDCS with routine Physical Therapy) and Group-C (MT with routine Physical Therapy), Blinding description: participant and Outcome assessor was blinded. 1 Cerebral Palsy. Intervention 1: Subjects will be evaluated for eligibility before allocation to one of three groups: Group-A (TDCS, MT with routine Physical Therapy), Group-B (TDCS with routine Physical Therapy) and Group-C (MT with routine Physical Therapy). Group A, which is the experimental group, will be treated for a 30-minute session of TDCS, with 15 minutes dedicated to the upper extremity at a 1 mA intensity and 15 minutes to the lower extremity at a 2 mA intensity in a comfortable seated position (Radwan et al., 2023) with routine physical therapy five days a week for 30 minutes each from the beginning of treatment to the completion of the treatment that is follow-up (weeks 1–10). Intervention 2: Group B, which is also a treatment group included in mirror therapy, will be 30 minutes: 15 minutes for the upper extremity and 15 minutes for the lower extremity. There will be a total of 10 sessions (5 times a week for 2 weeks), both for TDCS and mirror therapy treatment with routine physical therapy five days a week for 30 minutes each, from the beginning of treatment to the completion of the treatment that is follow-up (weeks 1–10). Intervention 3: Control group: Combinations of goal-directed functional training and reflex inhibitory patterns will be used under the umbrella of routine Physical Therapy. Goal-directed functional training, focusing on rehabilitation to help CP children perform functional activities and tasks for better quality of life, independence, and overall well-being that may have been compromised due to their neurological condition. Whatever the functional level of the patient in terms of motor development (gross motor, fine motor, communication, social interaction, and balance), muscle performance and control will be targeted, and activities will be planned as per the patient's capability and strength. Reflex inhibitory patterns are a set of neurological responses that help control and regulate reflex actions in the body, which are automatic, involuntary responses to stimuli in nature. They play a crucial role in protecting the body, feeding, initiating movement, and maintaining balance. In CP children, either reflexes are diminished or exaggerated, like the Moro and protective extension reflex (protective reflexes), rooting and sucking reflex (feeding reflexes), symmetrical tonic neck reflex, asymmetrical tonic neck reflex, tonic labyrinthine reflex (postural reflex), equilibrium reactions, head of body, body on head, or body on body reactions (righting reactions). For integration or inhibition of these reflexes, repeated stimuli and special postures will be adapted for better neuromuscular development. Yes - There is a plan to make this available What will be shared: EFFECTS OF TRANSCRANIAL DIRECT CURRENT STIMULATION WITH AND WITHOUT MIRROR THERAPY ON NEUROMUSCULAR DEVELOPMENT AND MENTAL HEALTH IN CHILDREN WITH SPASTIC QUADRIPLEGIC CP When: After Analysis till the publication of my work To whom: drshoaibwaqas@gmail.com Conditions: Confidential Where to obtain: Department of Physical Therapy And Rehabilitation GTTH Lahore How to obtain: Simply Do an Email Comments:
public Ashfaq Ahmad
The University of Lahore, Bhobhatian Chowk
Lahore Pakistan 55150 +92 300 9449192 ashfaq.ahmad@uipt.uol.edu.pk The University of Lahore scientific Shoaib Waqas
The University of Lahore, Bhobhatian Chowk
Lahore Pakistan 55150 +92 302 4552109 drshoaibwaqas@gmail.com The university of Lahore Pakistan Diagnosed patients of spastic quadriplegic cerebral palsy via physical examination aged from 3-7 years from both genders , Level-I and II patients on the Gross Motor Function Classification System (GMFCS) who can walk with or without assistance, respectively , Tone less than or equal to 2 on the modified Ashworth scale Having good understanding for the commands 3 years 7 years Both Athetoid cerebral palsy, ataxic an mixed variety will be excluded• Monoplegia, diplegic hemiplegic cerebral palsy patients will be excluded• History of any neurosurgery or neurolytic block (botulinum toxin and phenol) in the previous 6 months or any cancerous history or orthopedic deformity Any integumentary condition, seizure history or metal implant especially in the skull or use of hearing aids G80.0 Spastic quadriplegic cerebral palsy Rehabilitation Rehabilitation Rehabilitation Subjects will be evaluated for eligibility before allocation to one of three groups: Group-A (TDCS, MT with routine Physical Therapy), Group-B (TDCS with routine Physical Therapy) and Group-C (MT with routine Physical Therapy). Group A, which is the experimental group, will be treated for a 30-minute session of TDCS, with 15 minutes dedicated to the upper extremity at a 1 mA intensity and 15 minutes to the lower extremity at a 2 mA intensity in a comfortable seated position (Radwan et al., 2023) with routine physical therapy five days a week for 30 minutes each from the beginning of treatment to the completion of the treatment that is follow-up (weeks 1–10). Group B, which is also a treatment group included in mirror therapy, will be 30 minutes: 15 minutes for the upper extremity and 15 minutes for the lower extremity. There will be a total of 10 sessions (5 times a week for 2 weeks), both for TDCS and mirror therapy treatment with routine physical therapy five days a week for 30 minutes each, from the beginning of treatment to the completion of the treatment that is follow-up (weeks 1–10). Control group: Combinations of goal-directed functional training and reflex inhibitory patterns will be used under the umbrella of routine Physical Therapy. Goal-directed functional training, focusing on rehabilitation to help CP children perform functional activities and tasks for better quality of life, independence, and overall well-being that may have been compromised due to their neurological condition. Whatever the functional level of the patient in terms of motor development (gross motor, fine motor, communication, social interaction, and balance), muscle performance and control will be targeted, and activities will be planned as per the patient's capability and strength. Reflex inhibitory patterns are a set of neurological responses that help control and regulate reflex actions in the body, which are automatic, involuntary responses to stimuli in nature. They play a crucial role in protecting the body, feeding, initiating movement, and maintaining balance. In CP children, either reflexes are diminished or exaggerated, like the Moro and protective extension reflex (protective reflexes), rooting and sucking reflex (feeding reflexes), symmetrical tonic neck reflex, asymmetrical tonic neck reflex, tonic labyrinthine reflex (postural reflex), equilibrium reactions, head of body, body on head, or body on body reactions (righting reactions). For integration or inhibition of these reflexes, repeated stimuli and special postures will be adapted for better neuromuscular development. Motor development, Motor control, muscle performance, anthropometry, mental health. Timepoint: Before treatment, after two weeks and after 10 weeks. Method of measurement: Shoaib motor development tool, Fugal Mayer, isokinetic Dynamometer, Tape, stadiometer and weight machine, SDQ questionnaire. Quality of life. Timepoint: before treatment, after 6months. Method of measurement: SF-36. Nil Approved 2023-10-05 Research Ethics Committee (REC) The University of Lahore, Bhobhatian Chowk Lahore Punjab Pakistan