HEMI-STIM. tDCS and Intensive Therapies

Infantile Hemiplegia Clinical Trial

Official title: Transcranial Direct Current Combined With Intensive Therapies in Infantile Hemiplegia. Triple-blind Randomized Clinical Trial

Status Completed

Clinical Trial Summary

Application of Transcranial Direct Current or placebo combined with Constraint Induced Movement Therapy (CIMT) and bimanual intensive therapy (BIT) in infantile hemiplegia (4-8 years). Before, after the treatment and 3 months after the treatment, the functionality of the affected upper limb will be assessed: Spontaneous use, alignment of the affected segment in movement, action of grasping and releasing an object with the wrist in a neutral position, extension and flexion and quality of life. CIMT will last 3 hours per day in a period of two weeks (10 days from M-F), and the transcranial direct current or placebo will be combined during the first 20 minutes of it. In addition, 45 minutes of BIT will be performed during the third week (3 days). The total time of the therapy will be 33 hours and 45 minutes. CIMT and BIT will have a playful and group performance model.

Clinical Trial Description

Objectives: To determine the efficacy of the combined application of transcranial direct current (tDCS) with a restraint-induced movement therapy program and bimanual therapy on quality of life, quality of movement and spontaneous use of the affected upper limb in children. with infantile hemiparesis.

Design: Randomized clinical trial with triple blind placebo control. Participants: 30 children between 4 and 8 years old diagnosed with infantile hemiparesis randomized into two groups.

Intervention: Program of 15 sessions (3 weeks) in which 20 minutes of cathodic tDCS (active or placebo) will be applied during the performance of 3 hours of restriction-induced movement therapy (CIMT) in the first two weeks and with 45 minutes of bimanual intensive therapy (TIB) in the third week. The effective duration of the intervention will be 33 hours and 45 minutes.

Variables: The outcome variables will be recorded before the intervention program, just after and three months after its completion.

Analysis: An intention-to-treat analysis will be performed. For the main result variables, a two-factor ANOVA (intervention-time) will be performed with a post-hoc analysis with Bonferroni correction. ;

Related Conditions & MeSH terms

• Hemiplegia
• Infantile Hemiplegia

• NCT number: NCT05226910
• Study type: Interventional
• Source: University of Castilla-La Mancha
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Completion date: October 1, 2022