Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2026-01-08 @ 5:36 AM
Study NCT ID:
NCT02397161
Status:
UNKNOWN
Last Update Posted:
2015-12-15
First Post:
2015-03-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mental Attention-neuromuscular Training for Children With Developmental Coordination Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019957', 'term': 'Motor Skills Disorders'}], 'ancestors': [{'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 172}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-12-13', 'studyFirstSubmitDate': '2015-03-09', 'studyFirstSubmitQcDate': '2015-03-23', 'lastUpdatePostDateStruct': {'date': '2015-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in motor control test composite latency score', 'timeFrame': 'Baseline (0 month), post-intervention (3 months), and 3-month follow-up (6 months)'}], 'secondaryOutcomes': [{'measure': 'Change in EEG mental attention level', 'timeFrame': 'Baseline (0 month), post-intervention (3 months), and 3-month follow-up (6 months)'}, {'measure': 'Change in surface EMG lower limb muscle onset latency', 'timeFrame': 'Baseline (0 month), post-intervention (3 months), and 3-month follow-up (6 months)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Developmental Coordination Disorder']}, 'descriptionModule': {'briefSummary': '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).\n\nDesign: 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.', 'detailedDescription': '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.\n\nObjective: To compare the effectiveness of AT-NMT, NMT alone, AT alone, and no intervention for improving reactive balance performance among children with DCD.\n\nDesign: 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.\n\nAnticipated 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 6 to 9 years old;\n2. a formal diagnosis of DCD based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) at a child assessment center;\n3. a Bruininks-Oseretsky Test of Motor Proficiency giving a gross motor composite score of ≤42;\n4. a Child Behavior Checklist attention problem subscale T score of ≥54.5, indicating an attention deficit;\n5. attending a local mainstream school;\n6. an intelligence level within the normal range; and\n7. no experience in using the Brain Computer Interface system or similar apparatus.\n\nExclusion Criteria:\n\n1. a diagnosis of neurological or other movement disorder;\n2. any cognitive, psychiatric (comorbid ADHD will not be excluded), congenital, musculoskeletal or cardiopulmonary disorder that can affect motor performance;\n3. receiving active therapies or treatments including complementary and alternative medicine;\n4. demonstrating excessive disruptive behavior; or\n5. those unable to follow instructions adequately.'}, 'identificationModule': {'nctId': 'NCT02397161', 'briefTitle': 'Mental Attention-neuromuscular Training for Children With Developmental Coordination Disorder', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Improving Mental Attention, Timing of Muscle Activation and Reactive Balance Control in Children With Developmental Coordination Disorder: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '17120515'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AT-NMT', 'description': 'AT-NMT group - will receive a 12-week EEG biofeedback mental attention-neuromuscular training', 'interventionNames': ['Other: EEG biofeedback mental attention-neuromuscular training']}, {'type': 'EXPERIMENTAL', 'label': 'NMT alone', 'description': 'NMT group - will receive a 12-week neuromuscular training', 'interventionNames': ['Other: Neuromuscular training']}, {'type': 'EXPERIMENTAL', 'label': 'AT alone', 'description': 'AT group - will receive a 12-week EEG biofeedback mental attention training', 'interventionNames': ['Other: EEG biofeedback mental attention training']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Control group - no intervention for 12 weeks'}], 'interventions': [{'name': 'EEG biofeedback mental attention-neuromuscular training', 'type': 'OTHER', 'description': 'Mental attention training using EEG biofeedback and neuromuscular training using physio-therapeutic exercises', 'armGroupLabels': ['AT-NMT']}, {'name': 'Neuromuscular training', 'type': 'OTHER', 'description': 'Neuromuscular training using physio-therapeutic exercises', 'armGroupLabels': ['NMT alone']}, {'name': 'EEG biofeedback mental attention training', 'type': 'OTHER', 'description': 'Mental attention training using EEG biofeedback', 'armGroupLabels': ['AT alone']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Pokfulam', 'country': 'Hong Kong', 'contacts': [{'name': 'Shirley SM Fong, PT, PhD', 'role': 'CONTACT', 'email': 'smfong@hku.hk', 'phone': '852-97090337'}], 'facility': 'University of Hong Kong'}], 'centralContacts': [{'name': 'Shirley SM Fong, PT, PhD', 'role': 'CONTACT', 'email': 'smfong@hku.hk', 'phone': '+85297090337'}], 'overallOfficials': [{'name': 'Shirley SM Fong, PT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, DRPC chairperson', 'investigatorFullName': 'Shirley S.M. Fong', 'investigatorAffiliation': 'The University of Hong Kong'}}}}