Effects of Transcranial Direct Current Stimulation on Balance of Children With Balance Deficit

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-20

Study Completion Date

2021-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of tDCS on Postural Control of Children With DCD

NCT03892083

Developmental Coordination Disorder

UNKNOWN NA

Effect of Transcranial Direct Current Stimulation on Risk of Falling in Cerebral Palsy Spastic Hemiplegic Children

NCT06730763

Cerebral Palsy (CP)

RECRUITING NA

Does tDCS Improve Motor Learning in Children With DCD?

NCT03453983

Developmental Coordination Disorder

COMPLETED NA

tDCS and Bimanual Therapy for Children With Hemiplegic Cerebral Palsy

NCT03402854

Cerebral Palsy Hemiplegic Cerebral Palsy Spastic Hemiplegic Cerebral Palsy +2 more

RECRUITING NA

Transcranial Direct Current Stimulation and Treadmill in Cerebral Palsy

NCT07342660

Cerebral Palsy (CP)

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Maintaining body position and orientation is a complex and multifactorial task. Balance is defined as the ability to control and maintain the center of gravity or center of mass over the area of the support base. Postural control system aims (1) to maintain balance and postural orientation (2) to perform voluntary movement in static or dynamic circumstances and (3) to react to internal and external disturbances. Neural control of posture will be efficient when there is an interaction of sensory and motor information from multiple structures, and it will vary according to the age of the individuals, maturation of the structures involved, motor repertoire, neuromuscular synergies and musculoskeletal components, among others. The primary motor cortex (M1) has been persistently studied due to its complexity, numerous connections and direct involvement with motor control. Studies suggest that the main neural activity of M1 is to command muscle activity and optimize the effector system´s operation, producing a more uniform, efficient and coordinated motor response, including postural responses to mechanical disturbances.

When one of the organs involved in this function is compromised, regardless of the age of the individuals, whether due to injury or a change in functioning or integration, body oscillations happen. Historically, balance deficit (and consequent falls) are considered normal and acceptable in childhood, however, it is necessary to be careful with falls and their consequences in children with mobility or behavioral diseases. Physical therapy is essential in the rehabilitation of children and adults with balance deficit, with or without injury in nervous system. Currently, there is an increasing number of studies that have pointed Transcranial direct current stimulation (TDCS) as an efficient and safe device to modulate motor performance. To our knowledge, despite this growing number of studies, little is known about how much TDCS could add to an balance exercise protocol for children without structural damage in nervous system with balance deficit. Therefore, it is relevant to carry out studies in order to investigate and possibly elucidate the effects of TDCS on postural control and balance in children. Thus, 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postural Balance

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Anodal tDCS + Exercise

Anodal tDCS applied over primary motor cortex (M1) - Dose: 1mA, 20 minutes + ( concomitantly) protocol of specific exercises for balance

Group Type EXPERIMENTAL

Transcranial direct current stimulation (tDCS)

Intervention Type DEVICE

Transcranial direct current stimulation is a noninvasive technique of neuronal modulation.

Balance exercises

Intervention Type OTHER

Specific balance exercises, focused on balance, postural control and control of the center of gravity within the support base.

Sham tDCS + Exercise

Sham tDCS applied over primary motor cortex (M1) - Dose: 1mA, 30 seconds ON, + (concomitantly) protocol of specific exercises for balance

Group Type SHAM_COMPARATOR

Transcranial direct current stimulation (tDCS)

Intervention Type DEVICE

Transcranial direct current stimulation is a noninvasive technique of neuronal modulation.

Balance exercises

Intervention Type OTHER

Specific balance exercises, focused on balance, postural control and control of the center of gravity within the support base.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Transcranial direct current stimulation (tDCS)

Transcranial direct current stimulation is a noninvasive technique of neuronal modulation.

Intervention Type DEVICE

Balance exercises

Specific balance exercises, focused on balance, postural control and control of the center of gravity within the support base.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* visual or auditory deficiencies; cardiopathies; rheumatic or orthopedic dysfunctions; neurological or psychiatric problems (except Attention Deficit Hyperactivity Disorder and Developmental Coordination Disorder).

Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes