Developmental Coordination DisorderNCT02397161
Mental Attention-neuromuscular Training for Children With Developmental Coordination Disorder
A study testing EEG biofeedback mental attention-neuromuscular training, Neuromuscular training and EEG biofeedback mental attention training in people with Developmental Coordination Disorder, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Objective: To compare the effectiveness of EEG biofeedback mental attention-neuromuscular training (AT-NMT), neuromuscular training (NMT) alone, EEG biofeedback mental attention training (AT) alone, and no intervention for improving reactive balance performance among children with developmental coordination disorder… Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- Developmental Coordination Disorder
- What is being tested?
- EEG biofeedback mental attention-neuromuscular training, Neuromuscular training and EEG biofeedback mental attention training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteHong Kong
- Study dates
- Jul 2016to Jul 2017
- 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 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 6 to 9 years old;
- a formal diagnosis of DCD based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) at a child assessment center;
- a Bruininks-Oseretsky Test of Motor Proficiency giving a gross motor composite score of ≤42;
- a Child Behavior Checklist attention problem subscale T score of ≥54.5, indicating an attention deficit;
- attending a local mainstream school;
- an intelligence level within the normal range; and
- no experience in using the Brain Computer Interface system or similar apparatus.
Who cannot join
- a diagnosis of neurological or other movement disorder;
- any cognitive, psychiatric (comorbid ADHD will not be excluded), congenital, musculoskeletal or cardiopulmonary disorder that can affect motor performance;
- receiving active therapies or treatments including complementary and alternative medicine;
- demonstrating excessive disruptive behavior; or
- those unable to follow instructions adequately.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
University of Hong Kong
Pokfulam
Shirley SM Fong, PT, PhD, 852-97090337, smfong@hku.hk
About this study
Official title: Improving Mental Attention, Timing of Muscle Activation and Reactive Balance Control in Children With Developmental Coordination Disorder: A Randomized Controlled Trial
Objective: To compare the effectiveness of EEG biofeedback mental attention-neuromuscular training (AT-NMT), neuromuscular training (NMT) alone, EEG biofeedback mental attention training (AT) alone, and no intervention for improving reactive balance performance among children with developmental coordination disorder (DCD).
Design: A single-blinded, randomized controlled clinical trial. Sample: 172 children with DCD. Interventions: AT-NMT, NMT, AT, or no intervention for 12 weeks. Major outcomes: Outcomes will be evaluated at baseline, post-intervention, and 3-month follow-up. A motor control test (MCT) will give a composite latency score, prefrontal cortex EEG recordings during MCT will measure the mental attention level, and surface electromyography recordings during MCT will indicate the lower limb muscle onset latency.
Read the detailed description
Hypothesis: The Investigators hypothesize that the reactive balance performance in children with DCD can be best improved by treating both their mental attention and neuromuscular deficits.
Objective: To compare the effectiveness of AT-NMT, NMT alone, AT alone, and no intervention for improving reactive balance performance among children with DCD.
Design: A single-blinded, randomized controlled clinical trial. Sample: 172 children with DCD. Interventions: AT-NMT, NMT, AT, or no intervention for 12 weeks. Major outcomes: Outcomes will be evaluated at baseline, post-intervention, and 3-month follow-up. A motor control test (MCT) will give a composite latency score, prefrontal cortex EEG recordings during MCT will measure the mental attention level, and surface electromyography recordings during MCT will indicate the lower limb muscle onset latency.
Anticipated results and clinical significance: Children with DCD who receive AT-NMT will have the best reactive balance performance outcomes. If the results are positive, this novel training regime can be readily adopted in clinical practice. AT-NMT will improve overall well-being in these children and have positive socio-economic implications such as shorter rehabilitation periods and reduced healthcare costs.
- Conditions
- Developmental Coordination Disorder
- Being tested
- EEG biofeedback mental attention-neuromuscular training, Neuromuscular training, EEG biofeedback mental attention training
- Medical subject headings
- Motor Skills Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG biofeedback mental attention-neuromuscular trainingOther
Mental attention training using EEG biofeedback and neuromuscular training using physio-therapeutic exercises
Neuromuscular trainingOther
Neuromuscular training using physio-therapeutic exercises
EEG biofeedback mental attention trainingOther
Mental attention training using EEG biofeedback
| Study group | Role | What they receive |
|---|---|---|
| AT-NMT | Experimental | AT-NMT group - will receive a 12-week EEG biofeedback mental attention-neuromuscular training Receives: Other: EEG biofeedback mental attention-neuromuscular training |
| NMT alone | Experimental | NMT group - will receive a 12-week neuromuscular training Receives: Other: Neuromuscular training |
| AT alone | Experimental | AT group - will receive a 12-week EEG biofeedback mental attention training Receives: Other: EEG biofeedback mental attention training |
| Control | No intervention | Control group - no intervention for 12 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in motor control test composite latency score
Measured: Baseline (0 month), post-intervention (3 months), and 3-month follow-up (6 months)
Secondary outcomes (2)
Change in EEG mental attention level
Measured: Baseline (0 month), post-intervention (3 months), and 3-month follow-up (6 months)
Change in surface EMG lower limb muscle onset latency
Measured: Baseline (0 month), post-intervention (3 months), and 3-month follow-up (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startJul 2016
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental Coordination DisorderStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shirley S.M. Fong, The University of Hong Kong
- Investigators
- Shirley SM Fong, PT, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02397161
- Sponsor's protocol ID
- 17120515
- Status last verified
- Dec 2015
- First submitted
- 9 Mar 2015
- Last updated
- 15 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Mental Attention, Timing of Muscle Activation and Reactive Balance Control in Children With Developmental Coordination Disorder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02397161
- Acronym / sponsor ID
- 17120515
- Conditions
- Developmental Coordination Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 24 Mar 2015 (estimated)
- 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.
Objective: To compare the effectiveness of EEG biofeedback mental attention-neuromuscular training (AT-NMT), neuromuscular training (NMT) alone, EEG biofeedback mental attention training (AT) alone, and no intervention for improving reactive balance performance among children with developmental coordination disorder (DCD).
Design: A single-blinded, randomized controlled clinical trial. Sample: 172 children with DCD. Interventions: AT-NMT, NMT, AT, or no intervention for 12 weeks. Major outcomes: Outcomes will be evaluated at baseline, post-intervention, and 3-month follow-up. A motor control test (MCT) will give a composite latency score, prefrontal cortex EEG recordings during MCT will measure the mental attention level, and surface electromyography recordings during MCT will indicate the lower limb muscle onset latency.
Detailed description
Hypothesis: The Investigators hypothesize that the reactive balance performance in children with DCD can be best improved by treating both their mental attention and neuromuscular deficits.
Objective: To compare the effectiveness of AT-NMT, NMT alone, AT alone, and no intervention for improving reactive balance performance among children with DCD.
Design: A single-blinded, randomized controlled clinical trial. Sample: 172 children with DCD. Interventions: AT-NMT, NMT, AT, or no intervention for 12 weeks. Major outcomes: Outcomes will be evaluated at baseline, post-intervention, and 3-month follow-up. A motor control test (MCT) will give a composite latency score, prefrontal cortex EEG recordings during MCT will measure the mental attention level, and surface electromyography recordings during MCT will indicate the lower limb muscle onset latency.
Anticipated results and clinical significance: Children with DCD who receive AT-NMT will have the best reactive balance performance outcomes. If the results are positive, this novel training regime can be readily adopted in clinical practice. AT-NMT will improve overall well-being in these children and have positive socio-economic implications such as shorter rehabilitation periods and reduced healthcare costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AT-NMT | Experimental | Other: EEG biofeedback mental attention-neuromuscular trainingAT-NMT group - will receive a 12-week EEG biofeedback mental attention-neuromuscular training |
| NMT alone | Experimental | Other: Neuromuscular trainingNMT group - will receive a 12-week neuromuscular training |
| AT alone | Experimental | Other: EEG biofeedback mental attention trainingAT group - will receive a 12-week EEG biofeedback mental attention training |
| Control | No intervention | –Control group - no intervention for 12 weeks |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 6 to 9 years old;
- a formal diagnosis of DCD based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) at a child assessment center;
- a Bruininks-Oseretsky Test of Motor Proficiency giving a gross motor composite score of ≤42;
- a Child Behavior Checklist attention problem subscale T score of ≥54.5, indicating an attention deficit;
- attending a local mainstream school;
Key exclusion criteria (5 listed)
- a diagnosis of neurological or other movement disorder;
- any cognitive, psychiatric (comorbid ADHD will not be excluded), congenital, musculoskeletal or cardiopulmonary disorder that can affect motor performance;
- receiving active therapies or treatments including complementary and alternative medicine;
- demonstrating excessive disruptive behavior; or
- those unable to follow instructions adequately.
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 |
|---|---|---|
| EEG biofeedback mental attention-neuromuscular trainingMental attention training using EEG biofeedback and neuromuscular training using physio-therapeutic exercises | Other | AT-NMT |
| Neuromuscular trainingNeuromuscular training using physio-therapeutic exercises | Other | NMT alone |
| EEG biofeedback mental attention trainingMental attention training using EEG biofeedback | Other | AT alone |
Primary outcome
Change in motor control test composite latency score
Time frame: Baseline (0 month), post-intervention (3 months), and 3-month follow-up (6 months)
2 secondary outcomes
Change in EEG mental attention level
Time frame: Baseline (0 month), post-intervention (3 months), and 3-month follow-up (6 months)
Change in surface EMG lower limb muscle onset latency
Time frame: Baseline (0 month), post-intervention (3 months), and 3-month follow-up (6 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2015.
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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.
Shirley SM Fong, PT, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EEG biofeedback mental attention-neuromuscular training, Neuromuscular training and EEG biofeedback mental attention training in people with Developmental Coordination Disorder, run by The University of Hong Kong at 1 site in Hong Kong.
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 7 inclusion and 5 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 15 Dec 2015. 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 Hong Kong. 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. 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 Shirley SM Fong, PT, PhD (+85297090337, smfong@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in motor control test composite latency score (time frame: Baseline (0 month), post-intervention (3 months), and 3-month follow-up (6 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 15 Dec 2015.