Effects of Transcranial Direct Current Stimulation on Balance of Children With Balance Deficit
Additive Effect of Transcranial Direct Current Stimulation on Physiotherapeutic Treatment of Children With Balance Deficit: a Randomized, Controlled, Double-blind Clinical Trial
1 other identifier
interventional
26
1 country
1
Brief Summary
Neural control of posture depends on interaction of sensory and motor information from multiple structures, including the primary motor cortex (M1). Transcranial direct current stimulation (TDCS) improves postural control in children and adults with and without neurological disorders, however, additive effects to physical therapy treatment are still unknown, specifically balance exercises for children with balance deficit. The aim of this study is to identify the effects of adding anodic TDCS over M1 to exercises on postural control of children with balance deficit. This is a randomized, double-blind, controlled clinical trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2020
CompletedFirst Posted
Study publicly available on registry
April 10, 2020
CompletedStudy Start
First participant enrolled
June 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2021
CompletedApril 10, 2020
March 1, 2020
5 months
March 16, 2020
April 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Displacement of COP (center of pressure)
AP (anteroposterior) displacement (cm), ML (mediolateral) displacement (cm), area of the displacement (cm2) and velocity of the displacement (cm/sec)
through study completion, an average of 10 months
Secondary Outcomes (2)
Motor performance in dynamics balance tasks
through study completion, an average of 10 months
Motor performance in balance scale (dynamic and static balance tasks)
through study completion, an average of 10 months
Study Arms (2)
Anodal tDCS + Exercise
EXPERIMENTALAnodal tDCS applied over primary motor cortex (M1) - Dose: 1mA, 20 minutes + ( concomitantly) protocol of specific exercises for balance
Sham tDCS + Exercise
SHAM COMPARATORSham tDCS applied over primary motor cortex (M1) - Dose: 1mA, 30 seconds ON, + (concomitantly) protocol of specific exercises for balance
Interventions
Transcranial direct current stimulation is a noninvasive technique of neuronal modulation.
Specific balance exercises, focused on balance, postural control and control of the center of gravity within the support base.
Eligibility Criteria
You may qualify if:
- children of both sex
- aged between 6 -11 years old;
- assent of the child by the Term of Assent and acceptance of parents and / or guardians to participate in the study by signing the Free and Informed Consent Form;
- children with percentile \<=5 in the MABC-2(Movement Assessment Battery for Children second edition) Motor Evaluation Battery and in the balance domain and \<=25 in total score
- children with percentile \<=9 in the MABC-2 Motor Evaluation Battery and in the balance domain and \<=5 in total score
You may not qualify if:
- visual or auditory deficiencies; cardiopathies; rheumatic or orthopedic dysfunctions; neurological or psychiatric problems (except Attention Deficit Hyperactivity Disorder and Developmental Coordination Disorder).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Physical Therapy, Communication Sciences and Disorders, and Occupational Therapy, Faculty of Medicine, University of São Paulo
São Paulo, 01246-903, Brazil
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Renata Hydee Hasue
Faculty of Medicine, University of São Paulo
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2020
First Posted
April 10, 2020
Study Start
June 20, 2020
Primary Completion
December 1, 2020
Study Completion
February 1, 2021
Last Updated
April 10, 2020
Record last verified: 2020-03