Status:
COMPLETED
HEMI-STIM. tDCS and Intensive Therapies
Lead Sponsor:
University of Castilla-La Mancha
Conditions:
Infantile Hemiplegia
Eligibility:
All Genders
4-8 years
Phase:
NA
Brief 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 t...
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, quali...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2022
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT05226910
Start Date
October 1 2021
End Date
October 1 2022
Last Update
January 18 2023
Active Locations (1)
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1
University of Castilla-La Mancha
Toledo, Spain, 45071