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Mental Attention-neuromuscular Training for Children With Developmental Coordination Disorder

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ClinicalTrials.gov Identifier: NCT02397161
Recruitment Status : Unknown
Verified December 2015 by Shirley S.M. Fong, The University of Hong Kong.
Recruitment status was:  Not yet recruiting
First Posted : March 24, 2015
Last Update Posted : December 15, 2015
Sponsor:
Information provided by (Responsible Party):
Shirley S.M. Fong, The University of Hong Kong

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.


Condition or disease Intervention/treatment Phase
Developmental Coordination Disorder Other: EEG biofeedback mental attention-neuromuscular training Other: Neuromuscular training Other: EEG biofeedback mental attention training Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Mental Attention, Timing of Muscle Activation and Reactive Balance Control in Children With Developmental Coordination Disorder: A Randomized Controlled Trial
Study Start Date : July 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Arm Intervention/treatment
Experimental: AT-NMT
AT-NMT group - will receive a 12-week EEG biofeedback mental attention-neuromuscular training
Other: 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
Other: Neuromuscular training
Neuromuscular training using physio-therapeutic exercises

Experimental: AT alone
AT group - will receive a 12-week EEG biofeedback mental attention training
Other: EEG biofeedback mental attention training
Mental attention training using EEG biofeedback

No Intervention: Control
Control group - no intervention for 12 weeks



Primary Outcome Measures :
  1. Change in motor control test composite latency score [ Time Frame: Baseline (0 month), post-intervention (3 months), and 3-month follow-up (6 months) ]

Secondary Outcome Measures :
  1. Change in EEG mental attention level [ Time Frame: Baseline (0 month), post-intervention (3 months), and 3-month follow-up (6 months) ]
  2. 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) ]


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Ages Eligible for Study:   6 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02397161


Contacts
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Contact: Shirley SM Fong, PT, PhD +85297090337 smfong@hku.hk

Locations
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Hong Kong
University of Hong Kong Not yet recruiting
Pokfulam, Hong Kong
Contact: Shirley SM Fong, PT, PhD    852-97090337    smfong@hku.hk   
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Shirley SM Fong, PT, PhD The University of Hong Kong

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Responsible Party: Shirley S.M. Fong, Assistant Professor, DRPC chairperson, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02397161     History of Changes
Other Study ID Numbers: 17120515
First Posted: March 24, 2015    Key Record Dates
Last Update Posted: December 15, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
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Disease
Motor Skills Disorders
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders