Clinical trial NCT02397161: Mental Attention-neuromuscular Training for Children With Developmental Coordination Disorder
Official title: Improving Mental Attention, Timing of Muscle Activation and Reactive Balance Control in Children With Developmental Coordination Disorder: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Developmental Coordination Disorder
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2015-03-24
Enrollment: 172
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 (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.

Eligibility criteria: Inclusion Criteria:

1. 6 to 9 years old;
2. a formal diagnosis of DCD based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) at a child assessment center;
3. a Bruininks-Oseretsky Test of Motor Proficiency giving a gross motor composite score of ≤42;
4. a Child Behavior Checklist attention problem subscale T score of ≥54.5, indicating an attention deficit;
5. attending a local mainstream school;
6. an intelligence level within the normal range; and
7. no experience in using the Brain Computer Interface system or similar apparatus.

Exclusion Criteria:

1. a diagnosis of neurological or other movement disorder;
2. any cognitive, psychiatric (comorbid ADHD will not be excluded), congenital, musculoskeletal or cardiopulmonary disorder that can affect motor performance;
3. receiving active therapies or treatments including complementary and alternative medicine;
4. demonstrating excessive disruptive behavior; or
5. those unable to follow instructions adequately.

Primary outcomes:
measure: Change in motor control test composite latency score
timeFrame: Baseline (0 month), post-intervention (3 months), and 3-month follow-up (6 months)
Secondary outcomes:
measure: Change in EEG mental attention level
timeFrame: Baseline (0 month), post-intervention (3 months), and 3-month follow-up (6 months)
measure: Change in surface EMG lower limb muscle onset latency
timeFrame: Baseline (0 month), post-intervention (3 months), and 3-month follow-up (6 months)
Other outcomes:
Locations:
city: Pokfulam
country: Hong Kong
facility: University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Shirley SM Fong, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: