Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2026-02-24 @ 1:41 PM
Study NCT ID:
NCT02780102
Status:
COMPLETED
Last Update Posted:
2021-02-03
First Post:
2016-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive-Motor Rehabilitation, Stimulant Drugs, and Active Control in the Treatment of ADHD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008774', 'term': 'Methylphenidate'}, {'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-02', 'studyFirstSubmitDate': '2016-05-19', 'studyFirstSubmitQcDate': '2016-05-20', 'lastUpdatePostDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Forward/backward digit span tasks from the Wechsler intelligence scale for children 4th edition (WISC-IV)', 'timeFrame': '12 months'}, {'measure': 'Span board task from the Lumosity.com online brain training software', 'timeFrame': '12 months'}, {'measure': 'Listening span task (L.SPAN)', 'timeFrame': '12 months'}, {'measure': 'Stroop color-word test', 'timeFrame': '12 months'}, {'measure': 'Tower of London test (TOL)', 'timeFrame': '12 months'}, {'measure': 'Restricted academic situation scale (RASS)', 'timeFrame': '12 months'}, {'measure': 'Arithmetic task from WISC-IV testing battery', 'timeFrame': '12 months'}, {'measure': "Swanson, Nolan, and Pelham's parent rating scale (SNAP-IV)", 'timeFrame': '12 months'}, {'measure': 'Dictation and Spelling examination', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ADHD', 'Cognitive-motor rehabilitation', 'Active Control Group', 'Stimulant Medication'], 'conditions': ['Attention Deficit Hyperactivity Disorder']}, 'descriptionModule': {'briefSummary': 'The investigators administered a randomized controlled trial (RCT) through random assignment of children with ADHD into three different groups to compare the effects of cognitive-motor rehabilitation, immediate release methylphenidate, and an active control on the executive functioning, learning, and behavioral symptoms of children with ADHD.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '9 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Receiving ADHD diagnosis\n* aged between 9 and 12 years\n* Intelligence Quotient (IQ)\\>90\n\nExclusion Criteria:\n\n* Severe co-morbid disorders, such as depression, op-positional defiant disorder and conduct disorder\n* A history of seizures during past 2 years\n* Disability or handicap preventing the child from participating cognitive-motor exercises\n* Sever medical conditions requiring immediate medical treatment'}, 'identificationModule': {'nctId': 'NCT02780102', 'acronym': 'ADHD', 'briefTitle': 'Cognitive-Motor Rehabilitation, Stimulant Drugs, and Active Control in the Treatment of ADHD', 'organization': {'class': 'OTHER', 'fullName': 'Allameh Tabatabai University'}, 'officialTitle': 'Comparison of the Effects of Cognitive-Motor Rehabilitation, Stimulant Drugs, and Active Control on Executive Functions and Clinical Symptoms of Attention Deficit/ Hyperactivity Disorder', 'orgStudyIdInfo': {'id': '328/94/16090'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive-Motor Rehabilitation', 'description': 'Cognitive-Motor Rehabilitation (CMR): 20 sixty-minute sessions of cognitive-motor rehabilitation', 'interventionNames': ['Other: Cognitive-Motor Rehabilitation']}, {'type': 'EXPERIMENTAL', 'label': 'Ritalin', 'description': '2 to 3 doses of 10 mg Ritalin tablets per day during 8 week.', 'interventionNames': ['Drug: Ritalin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Control', 'description': 'Active Control group simultaneously received 20 sixty-minute sessions of low dose cognitive-motor exercises', 'interventionNames': ['Other: Active Control']}], 'interventions': [{'name': 'Cognitive-Motor Rehabilitation', 'type': 'OTHER', 'description': 'Cognitive-Motor Rehabilitation (CMR) group received 20 sixty-minute sessions of cognitive-motor exercises', 'armGroupLabels': ['Cognitive-Motor Rehabilitation']}, {'name': 'Ritalin', 'type': 'DRUG', 'otherNames': ['drug therapy'], 'description': '2 or 3 doses of 10 mg tablets of immediate-release Methylphenidate (Ritalin) per day for 8 week.', 'armGroupLabels': ['Ritalin']}, {'name': 'Active Control', 'type': 'OTHER', 'description': 'Active Control group simultaneously received 20 sixty-minute sessions of low dose cognitive-motor exercises', 'armGroupLabels': ['Active Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'country': 'Iran', 'facility': 'Counseling and guidence Center of the Department of education of region 9 of Tehran', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Saeed Azami, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Semnan University'}, {'name': 'Zeynab AliMadadi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tehran University of medical Science'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allameh Tabatabai University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Mr.', 'investigatorFullName': 'Saeed Azami', 'investigatorAffiliation': 'Allameh Tabatabai University'}}}}