HEMI-STIM. tDCS and Intensive Therapies
Condition: Infantile Hemiplegia
MeSH terms: Hemiplegia
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): tDCS and intensive therapies; Sham and intensive therapies
Intervention type(s): Device; Device
Intervention description(s): This intervention will consist in the combination of tDCS with CIMT (30 hours) and then with BIT (3 hours and 45 minutes); This intervention will consist in the combination of sham tDCS with CIMT (30 hours) and then with BIT (3 hours and 45 minutes)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups: tDCS and Intensive therapies (experimental group), placebo and intensive therapies (control group)
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: infantile hemiplegia; upper extremity; transcranial direct current; children