Effect of pediatric constraint-induced movement therapy associated with transcranial direct current stimulation in children with cerebral palsy: a randomized, triple-blind, controlled trial with analysis of implementation and cost-effectiveness

• Grant number: 24/23018-7
• Support Opportunities: Regular Research Grants
• Start date: May 01, 2025
• End date: April 30, 2028
• Field of knowledge: Health Sciences - Physiotherapy and Occupational Therapy
• Principal Investigator: Sandra Regina Alouche
• Grantee: Sandra Regina Alouche
• Host Institution: Pró-Reitoria de Pós-Graduação, Pesquisa e Extensão. Universidade Cidade de São Paulo (UNICID). São Paulo , SP, Brazil
• Associated researchers: Andréa Vancetto Maglione

Abstract

Children with spastic hemiparesis-type Cerebral Palsy (CP) may present significant impairment of manual function. Constraint-induced movement therapy (CIMT) has been proven effective in improving manual function of the most affected upper limb and increasing its cortical representation. The association with transcranial direct current stimulation (tDCS) shows biological plausibility in enhancing these effects and ensuring the maintenance of results. Aim: To compare the additional effects of tDCS associated with CIMT and CIMT alone in terms of speed and dexterity of movement, frequency, quality, and spontaneity of use of the upper limbs in an uncontrolled environment in children and adolescents with spastic hemiparesis-type CP, immediately and 1, 3 and 6 months post-intervention, analyze the feasibility of implementation and cost-effectiveness. Methods: This randomized, triple-blind, controlled study will include 32 participants aged 6 to 16 years. After screening and medical clearance, sociodemographic, clinical, and physical-functional data will be collected. Participants will be randomly allocated into two groups: control (Pediatric CIMT + placebo tDCS) and intervention (Pediatric CIMT + tDCS). The intervention will last 3 weeks, 5x/week, 3 hours/day. Clinical outcomes will be obtained at the end of treatment (3 weeks), 1, 3 and 6 months after completing the protocol. The primary outcomes (quality and frequency of movement) will be assessed using the Pediatric Motor Activity Log Revised (PMAL-R) or Tween Motor Activity Log (TMAL), depending on the patient's age. Secondary outcomes (speed, dexterity and spontaneity of use of the upper limbs, impact on participation, maintenance of gains at 1, 3 and 6 months) will be assessed by the Box and Block Test, Pediatric Arm Function Test (PAFT) and Canadian Occupational Performance Measure (COPM). The evaluators, therapists applying the CIMT and patients will be blind to the intervention. The implementation analysis will be done using the Weiner scale. A cost-effectiveness analysis will be conducted comparing the association or not of tDCS in the CIMT protocol. Data analysis: Statistical analysis will follow intention-to-treat principles and differences between groups will be calculated by constructing linear mixed models. Expected results: It is expected to demonstrate that the association between CIMT and tDCS can generate longer-lasting gains in manual function in children with spastic hemiparesis-type CP. The implementation analysis aims to show that combining CIMT and tDCS is acceptable, suitable, viable for clinical use, and cost-effective. (AU)