Mental Attention-neuromuscular Training for Children With Developmental Coordination Disorder

December 13, 2015 updated by: Shirley S.M. Fong, The University of Hong Kong

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

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

Interventional

Enrollment (Anticipated)

172

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Pokfulam, Hong Kong
        • University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 9 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (ANTICIPATED)

July 1, 2017

Study Completion (ANTICIPATED)

July 1, 2017

Study Registration Dates

First Submitted

March 9, 2015

First Submitted That Met QC Criteria

March 23, 2015

First Posted (ESTIMATE)

March 24, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

December 15, 2015

Last Update Submitted That Met QC Criteria

December 13, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

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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