HEMI-STIM. tDCS and Intensive Therapies

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infantile Hemiplegia

Intervention / Treatment
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* Device: tDCS and intensive therapies
* Device: Sham and intensive therapies


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children between 4 and 8 years old, with a diagnosis of congenital infantile hemiplegia, with a score between levels I and III of the manual ability classification system (MACS) and a level I-III of the gross motor function classification system will be included (GMFCS). In addition, children must have a preserved cognitive ability to understand the execution of structured activities Exclusion Criteria: Having previously been treated with tDCS; Having been infiltrated with botulinum toxin 2 months prior to the intervention; Surgery of the upper limb the 6 months prior to the intervention; Pharmacologically uncontrolled epilepsy or having suffered epileptic seizures in the two years prior to the study (according to international recommendations for tDCS in children, Gillick et al., 2018); Contraindications of tDCS according to international recommendations. In addition, a withdrawal criterion will be non-attendance for more than 20% of the hours of the program.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two groups: tDCS and Intensive therapies (experimental group), placebo and intensive therapies (control group)
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tDCS and intensive therapies<br>Cathodal tDCS and constraint induce movement therapy | Device: tDCS and intensive therapies<br>* This intervention will consist in the combination of tDCS with CIMT (30 hours) and then with BIT (3 hours and 45 minutes)<br>|
| Sham Comparator: Sham and intensive therapies<br>Sham tDCS and constraint induce movement therapy | Device: Sham and intensive therapies<br>* This intervention will consist in the combination of sham tDCS with CIMT (30 hours) and then with BIT (3 hours and 45 minutes)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the spontaneous use of affected upper limb | This outcome will be assessed with Shuee evaluation. This evaluation uses the modified House scale which a maximum of 45 points can be obtained for the spontaneous use, and the values obtained can be converted into percentages. In addition, the dynamic positioning of the affected upper extremity is assessed through 16 structured activities in the Shuee evaluation (Positioning of the thumb, fingers, wrist, elbow, and forearm). TAcquiring a maximum score of 72 and their values can be considered in percentages. Another of the measured variables into the Shuee evaluation is the action of grasping and releasing an object with the wrist joint in different positions (results provided in percentages). This evaluation is validated for children with hemiplegia from 3 to 18 years old. | Baseline, post-treatment (at 13 days), and follow-up at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the experience of use of the affected upper limb | This outcome will be assessed with CHEQ questionnaire. It is validated for children with have reduction in the upper limb from 8 to 18 years old. It is a questionnaire composed of 27 questions about the activities of daily life and the execution of the task. Whether it is done with one hand, with both hands or with help and how effective is the use of the affected hand on a scale of 1-4, the time of execution of the task on a scale of 1-4 and the discomfort of execution of it on a scale of 1-4. It can be answered by the family, the therapist or the child himself from the age of 13. | Baseline, post-treatment (at 13 days), and follow-up at 12 weeks | 
| Change in the Quality of life in cerebral palsy | Use the PedsQL questionnaire to measure the quality of life. It is a questionnaire answered by the parents with children with cerebral palsy from 2-18 years old. It is made up of 35 items that describe different situations in the child's life. The questionnaire has different domains related to the physical activities, school activities, emotional activities, hygiene. The maximum score obtained can be 100 (0-100), which indicates that the higher the score, the better the quality of life. | Baseline, post-treatment (at 13 days), and follow-up at 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infantile hemiplegia, upper extremity, transcranial direct current, children