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NCT06438666 | NOT YET RECRUITING | Hemiparetic Cerebral Palsy

Effects Obtained at Manual Function After Applying Anodic Transcranial Direct Current Stimulation (tCDS) in Children With Spastic Hemiparetic Cerebral Palsy
Sponsor:

University of Malaga

Information provided by (Responsible Party):

Rocío Martin Valero

Brief Summary:

Spastic Hemiparetic Cerebral Palsy (SHCP) uses to limit the manual function. Using anodic transcranial direct current stimulation, it is possible to activate certain cerebral areas depending on where the electrodes are. This study will use this kind of stimulation on the contralateral primary motor cortex of the affected upper limb and analyze the effects.

Condition or disease

Hemiparetic Cerebral Palsy

Intervention/treatment

Anodic Transcranial Direct Current Stimulation

Phase

NA

Detailed Description:

It has been designed a single-arm prospective longitudinal quasi-experimental pilot clinical study following the SPIRIT 2013 statement. It will value the time that the children spend doing the bimanual activities described by the Children's Hand-Use Experience Questionnaire (CHEQ), it will also value the subjective experience doing those activities; it will analyze the active movement (Fugl-Meyer for upper limb), spasticity (modified Ashworth), manual strength (dynamometry) and the recruitment improvement (surface electromyography) too. This study will apply the anodic transcranial direct current stimulation over 20 children between 14-18 years old. The protocol that it will follow is the next one: 3 days to value the outcome measures, 4 days (1 session per day of 17 minutes and 30 seconds) to apply the protocol of anodic transcranial direct current stimulation (0,6 mA of intensity). It will use the EPTE V07 Bipolar System by IONCLINICS ®; 3 days to value the outcome measures studying the effects produced at the affected upper limb. Another evaluation will be realized 3 weeks after the last session of anodic transcranial direct current stimulation to know if the effects obtained last at medium-long term.

Study Type : INTERVENTIONAL
Estimated Enrollment : 20 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Quasi Experimental Study About the Effects Obtained at Manual Function After Applying Anodic Transcranial Direct Current Stimulation in Children With Spastic Hemiparetic Cerebral Palsy
Actual Study Start Date : 2025-03-20
Estimated Primary Completion Date : 2026-12-23
Estimated Study Completion Date : 2027-03-20

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 14 Years to 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Children between 14-18 years old.
  • * Children with spastic hemiparetic cerebral palsy diagnosis.
  • * Children with a cognitive level high enough to understand and to do the activities to value them.
  • * Children hemodynamically stable.
  • * Children forming part of levels II-IV of the Manual Ability Classification System (MACS).
Exclusion Criteria
  • * Children with defibrillator.
  • * Children with pacemaker.
  • * Children with cerebral stimulator.
  • * Children with intracranial metallic implants.
  • * Children with opened cranial after clambering.
  • * Children that receive another treatment (pharmacological or physiotherapical) that could interfere or disrupt the results.
  • * Another circumstance where the electrotherapy treatment is contraindicated.
Effects Obtained at Manual Function After Applying Anodic Transcranial Direct Current Stimulation (tCDS) in Children With Spastic Hemiparetic Cerebral Palsy

Location Details

NCT06438666

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How to Participate

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Locations

Not yet recruiting

Spain,

Rocío Martin Valero

Málaga, Spain, 29071