Mental Attention-neuromuscular Training for Children With Developmental Coordination Disorder

NCT ID: NCT02397161

Last Updated: 2015-12-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2017-07-31

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.

Conditions

Developmental Coordination Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

AT-NMT

AT-NMT group - will receive a 12-week EEG biofeedback mental attention-neuromuscular training

Group Type: EXPERIMENTAL

EEG biofeedback mental attention-neuromuscular training

Intervention Type: OTHER

Mental attention training using EEG biofeedback and neuromuscular training using physio-therapeutic exercises

NMT alone

NMT group - will receive a 12-week neuromuscular training

Group Type: EXPERIMENTAL

Neuromuscular training

Intervention Type: OTHER

Neuromuscular training using physio-therapeutic exercises

AT alone

AT group - will receive a 12-week EEG biofeedback mental attention training

Group Type: EXPERIMENTAL

EEG biofeedback mental attention training

Intervention Type: OTHER

Mental attention training using EEG biofeedback

Control

Control group - no intervention for 12 weeks

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

EEG biofeedback mental attention-neuromuscular training

Mental attention training using EEG biofeedback and neuromuscular training using physio-therapeutic exercises

Intervention Type: OTHER

Neuromuscular training

Neuromuscular training using physio-therapeutic exercises

Intervention Type: OTHER

EEG biofeedback mental attention training

Mental attention training using EEG biofeedback

Intervention Type: OTHER

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Shirley S.M. Fong

Assistant Professor, DRPC chairperson

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shirley SM Fong, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

University of Hong Kong

Pokfulam, , Hong Kong

Countries

Hong Kong

Central Contacts

Shirley SM Fong, PT, PhD

Role: CONTACT

Phone: +85297090337

Email: smfong@hku.hk

Facility Contacts

Shirley SM Fong, PT, PhD

Role: primary

Other Identifiers

17120515

Identifier Type: -

Identifier Source: org_study_id