- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02397161
Mental Attention-neuromuscular Training for Children With Developmental Coordination Disorder
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Pokfulam, Hong Kong
- University of Hong Kong
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: AT-NMT
AT-NMT group - will receive a 12-week EEG biofeedback mental attention-neuromuscular training
|
Mental attention training using EEG biofeedback and neuromuscular training using physio-therapeutic exercises
|
|
EXPERIMENTAL: NMT alone
NMT group - will receive a 12-week neuromuscular training
|
Neuromuscular training using physio-therapeutic exercises
|
|
EXPERIMENTAL: AT alone
AT group - will receive a 12-week EEG biofeedback mental attention training
|
Mental attention training using EEG biofeedback
|
|
NO_INTERVENTION: Control
Control group - no intervention for 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in motor control test composite latency score
Time Frame: Baseline (0 month), post-intervention (3 months), and 3-month follow-up (6 months)
|
Baseline (0 month), post-intervention (3 months), and 3-month follow-up (6 months)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in EEG mental attention level
Time Frame: Baseline (0 month), post-intervention (3 months), and 3-month follow-up (6 months)
|
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)
|
Baseline (0 month), post-intervention (3 months), and 3-month follow-up (6 months)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17120515
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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