Postural BalanceNCT04341220
Effects of Transcranial Direct Current Stimulation on Balance of Children With Balance Deficit
A study testing Transcranial direct current stimulation (tDCS) and Balance exercises in people with Postural Balance, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Postural Balance
- What is being tested?
- Transcranial direct current stimulation (tDCS) and Balance exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Jun 2020to Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- visual or auditory deficiencies; cardiopathies; rheumatic or orthopedic dysfunctions; neurological or psychiatric problems (except Attention Deficit Hyperactivity Disorder and Developmental Coordination Disorder).
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Department of Physical Therapy, Communication Sciences and Disorders, and Occupational Therapy, Faculty of Medicine, University of São Paulo
São Paulo, 01246-903
Jéssica O Martins, pHD, +5511961875883, jessica.smartins01@gmail.com
DS
About this study
Official title: Additive Effect of Transcranial Direct Current Stimulation on Physiotherapeutic Treatment of Children With Balance Deficit: a Randomized, Controlled, Double-blind Clinical Trial
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.
Read the detailed description
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
- Postural Balance
- Being tested
- Transcranial direct current stimulation (tDCS), Balance exercises
- Keywords
- Transcranial Direct Current Stimulation, Children, Child Development, Motor Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulation (tDCS)Device
Transcranial direct current stimulation is a noninvasive technique of neuronal modulation.
Balance exercisesOther
Specific balance exercises, focused on balance, postural control and control of the center of gravity within the support base.
| Study group | Role | What they receive |
|---|---|---|
| Anodal tDCS + Exercise | Experimental | Anodal tDCS applied over primary motor cortex (M1) - Dose: 1mA, 20 minutes + ( concomitantly) protocol of specific exercises for balance Receives: Device: Transcranial direct current stimulation (tDCS); Other: Balance exercises |
| Sham tDCS + Exercise | Sham comparator | Sham tDCS applied over primary motor cortex (M1) - Dose: 1mA, 30 seconds ON, + (concomitantly) protocol of specific exercises for balance Receives: Device: Transcranial direct current stimulation (tDCS); Other: Balance exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: through study completion, an average of 10 months
Secondary outcomes (2)
Motor performance in dynamics balance tasks
TUG Test
Measured: through study completion, an average of 10 months
Motor performance in balance scale (dynamic and static balance tasks)
Pediatric Balance Scale
Measured: through study completion, an average of 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start20 Jun 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural BalanceStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Sponsor
- Investigators
- Renata Hydee Hasue, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04341220
- Sponsor's protocol ID
- 17512619.0.0000.0065
- Status last verified
- Mar 2020
- First submitted
- 16 Mar 2020
- Last updated
- 10 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additive Effect of Transcranial Direct Current Stimulation on Physiotherapeutic Treatment of Children With Balance Deficit: a Randomized, Controlled, Double-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT04341220
- Acronym / sponsor ID
- 17512619.0.0000.0065
- Conditions
- Postural Balance
- Keywords
- Transcranial Direct Current Stimulation, Children, Child Development, Motor Control
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- 20 Jun 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 10 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anodal tDCS + Exercise | Experimental | Device: Transcranial direct current stimulation (tDCS), Other: Balance exercisesAnodal tDCS applied over primary motor cortex (M1) - Dose: 1mA, 20 minutes + ( concomitantly) protocol of specific exercises for balance |
| Sham tDCS + Exercise | Sham comparator | Device: Transcranial direct current stimulation (tDCS), Other: Balance exercisesSham tDCS applied over primary motor cortex (M1) - Dose: 1mA, 30 seconds ON, + (concomitantly) protocol of specific exercises for balance |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- visual or auditory deficiencies; cardiopathies; rheumatic or orthopedic dysfunctions; neurological or psychiatric problems (except Attention Deficit Hyperactivity Disorder and Developmental Coordination Disorder).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial direct current stimulation (tDCS)Transcranial direct current stimulation is a noninvasive technique of neuronal modulation. | Device | Anodal tDCS + Exercise, Sham tDCS + Exercise |
| Balance exercisesSpecific balance exercises, focused on balance, postural control and control of the center of gravity within the support base. | Other | Anodal tDCS + Exercise, Sham tDCS + Exercise |
Primary outcome
Displacement of COP (center of pressure)
Time frame: through study completion, an average of 10 months
AP (anteroposterior) displacement (cm), ML (mediolateral) displacement (cm), area of the displacement (cm2) and velocity of the displacement (cm/sec)
2 secondary outcomes
Motor performance in dynamics balance tasks
Time frame: through study completion, an average of 10 months
Motor performance in balance scale (dynamic and static balance tasks)
Time frame: through study completion, an average of 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renata Hydee Hasue principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation (tDCS) and Balance exercises in people with Postural Balance, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Renata Hydee Hasue (+5511983207232, renatahhv@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Displacement of COP (center of pressure) (time frame: through study completion, an average of 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2020.