Mental Attention-neuromuscular Training for Children With Developmental Coordination Disorder

Developmental Coordination Disorder Clinical Trial

Official title:

Improving Mental Attention, Timing of Muscle Activation and Reactive Balance Control in Children With Developmental Coordination Disorder: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02397161
• Other study ID #: 17120515
• Status: Not yet recruiting
• Phase: N/A
• First received: March 9, 2015
• Last updated: December 13, 2015
• Start date: July 2016
• Est. completion date: July 2017

Study information

• Verified date: December 2015
• Source: The University of Hong Kong
• Contact: Shirley SM Fong, PT, PhD
• Phone: +85297090337
• Email: smfong[@]hku.hk
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 172
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 9 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ataxia
• Developmental Coordination Disorder
• Motor Skills Disorders

Intervention

Other:
• EEG biofeedback mental attention-neuromuscular training
Mental attention training using EEG biofeedback and neuromuscular training using physio-therapeutic exercises
• Neuromuscular training
Neuromuscular training using physio-therapeutic exercises
• EEG biofeedback mental attention training
Mental attention training using EEG biofeedback

Locations

Country	Name	City	State
Hong Kong	University of Hong Kong	Pokfulam

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in motor control test composite latency score		Baseline (0 month), post-intervention (3 months), and 3-month follow-up (6 months)	No
Secondary	Change in EEG mental attention level		Baseline (0 month), post-intervention (3 months), and 3-month follow-up (6 months)	No
Secondary	Change in surface EMG lower limb muscle onset latency		Baseline (0 month), post-intervention (3 months), and 3-month follow-up (6 months)	No