Mental Attention-neuromuscular Training for Children With Developmental Coordination Disorder

NCT02397161 | Unknown DMC

• 1 other identifier: 17120515
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

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.

Conditions

Developmental Coordination Disorder

Outcome Measures

Primary Outcomes (1)

• Change in motor control test composite latency score

  Baseline (0 month), post-intervention (3 months), and 3-month follow-up (6 months)

Secondary Outcomes (2)

• Change in EEG mental attention level

  Baseline (0 month), post-intervention (3 months), and 3-month follow-up (6 months)

• Change in surface EMG lower limb muscle onset latency

  Baseline (0 month), post-intervention (3 months), and 3-month follow-up (6 months)

Study Arms (4)

AT-NMT

EXPERIMENTAL

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

Other: EEG biofeedback mental attention-neuromuscular training

NMT alone

EXPERIMENTAL

NMT group - will receive a 12-week neuromuscular training

Other: Neuromuscular training

AT alone

EXPERIMENTAL

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

Other: EEG biofeedback mental attention training

Control

NO INTERVENTION

Control group - no intervention for 12 weeks

Interventions

EEG biofeedback mental attention-neuromuscular training OTHER

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

AT-NMT

Neuromuscular training OTHER

Neuromuscular training using physio-therapeutic exercises

NMT alone

EEG biofeedback mental attention training OTHER

Mental attention training using EEG biofeedback

AT alone

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

University of Hong Kong

Pokfulam, Hong Kong

Location

MeSH Terms

Conditions

Motor Skills Disorders

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Shirley SM Fong, PT, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shirley SM Fong, PT, PhD

CONTACT

+85297090337; smfong@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, DRPC chairperson

Study Record Dates

• First Submitted: March 9, 2015
• First Posted: March 24, 2015
• Study Start: July 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: December 15, 2015

Record last verified: 2015-12

Locations

HK (1)