To check the effectiveness of transcranial direct current stimulation and mirror therapy on neonatal motor development and mental health in children with spastic quadriplegic cerebral palsy-Study protocol for randomized clinical trial

Background: Cerebral palsy (CP) is a non-progressive disorder resulting from undeveloped brain function leading to delays in motor, sensory, speech, and social interaction when compared to a normal, developed child. These structural and bodily insults prompt the infant towards disability (1). Transcranial direct current stimulation (TDCS) and mirror therapy (MT) work on the concept of neuroplasity to enhance the neuromuscular development of CP children. The response of this group to the mentioned therapies has never been investigated with a large sample size, which can mimic the concept of generalizability. The goal of this study is to compare the effects of transcranial direct current stimulation and mirror therapy on neuromuscular growth and mental well-being of the spastic quadriplegic cerebral palsy population. Methods: This is a single-centered, double blinded, and randomized clinical trial comprised of 105 CP patients aged 3–7 years. Sampling will be done by simple random, and allocation will be done by a random number table. The assessment will be taken at baseline (Pre-I), after two weeks (Post-I), and again after ten weeks of standard of care Physical Therapy treatment (Post-II), which is routine Physical Therapy. Study variables will be age, gender, height, weight, socioeconomic status, education, and severity of symptoms. The self-constructed Shoaib motor development tool will assess motor development, motor control by the Fugal Mayer assessment tool, and muscle performance by an isokinetic dynamometer, anthropometry by scales and measuring tape, and mental health by the SDQ questionnaire. Discussion: Researchers anticipate that TDCS and MT will stimulate neuromuscular development in terms of motor development and influence motor control, muscle performance, anthropometric factors, and hormonal change. This, in turn, is expected to uplift the mental wellbeing of CP children under the umbrella of neuroplasity. Ultimately, the child's entire developmental curve is positively impacted, therefore improving functional capability and participation across the short-term, mid-term, and long-term activity contexts. Registration of trial: On January 26, 2024, the trial was registered under the reference number IRCT20231227060542N1 on the Iranian Registry of Clinical Trials (IRCT).