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HEMI-STIM. tDCS and Intensive Therapies

NCT05226910 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-01-18

No results posted yet for this study

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.

Conditions

  • Infantile Hemiplegia

Interventions

DEVICE

tDCS and intensive therapies

This intervention will consist in the combination of tDCS with CIMT (30 hours) and then with BIT (3 hours and 45 minutes)

DEVICE

Sham and intensive therapies

This intervention will consist in the combination of sham tDCS with CIMT (30 hours) and then with BIT (3 hours and 45 minutes)

Sponsors & Collaborators

  • University of Castilla-La Mancha

    lead OTHER

Principal Investigators

  • Julio Gómez-Soriano, PhD · Castilla-La Mancha University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2022-07-30
Completion
2022-10-01

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05226910 on ClinicalTrials.gov