Mental Attention-neuromuscular Training for Children With Developmental Coordination Disorder
Primary Purpose
Developmental Coordination Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
EEG biofeedback mental attention-neuromuscular training
Neuromuscular training
EEG biofeedback mental attention training
Sponsored by
About this trial
This is an interventional treatment trial for Developmental Coordination Disorder
Eligibility Criteria
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.
Sites / Locations
- University of Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
AT-NMT
NMT alone
AT alone
Control
Arm Description
AT-NMT group - will receive a 12-week EEG biofeedback mental attention-neuromuscular training
NMT group - will receive a 12-week neuromuscular training
AT group - will receive a 12-week EEG biofeedback mental attention training
Control group - no intervention for 12 weeks
Outcomes
Primary Outcome Measures
Change in motor control test composite latency score
Secondary Outcome Measures
Change in EEG mental attention level
Change in surface EMG lower limb muscle onset latency
Full Information
NCT ID
NCT02397161
First Posted
March 9, 2015
Last Updated
December 13, 2015
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT02397161
Brief Title
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
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Coordination Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
172 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AT-NMT
Arm Type
Experimental
Arm Description
AT-NMT group - will receive a 12-week EEG biofeedback mental attention-neuromuscular training
Arm Title
NMT alone
Arm Type
Experimental
Arm Description
NMT group - will receive a 12-week neuromuscular training
Arm Title
AT alone
Arm Type
Experimental
Arm Description
AT group - will receive a 12-week EEG biofeedback mental attention training
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control group - no intervention for 12 weeks
Intervention Type
Other
Intervention Name(s)
EEG biofeedback mental attention-neuromuscular training
Intervention Description
Mental attention training using EEG biofeedback and neuromuscular training using physio-therapeutic exercises
Intervention Type
Other
Intervention Name(s)
Neuromuscular training
Intervention Description
Neuromuscular training using physio-therapeutic exercises
Intervention Type
Other
Intervention Name(s)
EEG biofeedback mental attention training
Intervention Description
Mental attention training using EEG biofeedback
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Change in EEG mental attention level
Time Frame
Baseline (0 month), post-intervention (3 months), and 3-month follow-up (6 months)
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shirley SM Fong, PT, PhD
Phone
+85297090337
Email
smfong@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shirley SM Fong, PT, PhD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Hong Kong
City
Pokfulam
Country
Hong Kong
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shirley SM Fong, PT, PhD
Phone
852-97090337
Email
smfong@hku.hk
12. IPD Sharing Statement
Learn more about this trial
Mental Attention-neuromuscular Training for Children With Developmental Coordination Disorder
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