Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-27 @ 9:16 PM
Study NCT ID:
NCT05067361
Status:
COMPLETED
Last Update Posted:
2021-10-05
First Post:
2021-09-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Aerobic Exercises on the Autistic Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D019956', 'term': 'Stereotypic Movement Disorder'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-10-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-04', 'studyFirstSubmitDate': '2021-09-23', 'studyFirstSubmitQcDate': '2021-10-04', 'lastUpdatePostDateStruct': {'date': '2021-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Repetitive behavior scale revised (RBS-R)', 'timeFrame': '3 weeks', 'description': 'RBS-R was used to assess the stereotypic behaviors of autistic children. It is 43 items questionnaire that is placed under six subscales. The sub-scales are Stereotyped Behavior Subscale Self-Injurious Behavior Subscale Compulsive Behavior Subscale Ritualistic Behavior Subscale Sameness Behavior Subscale Restricted Behavior Subscale Each subscale has different characteristics, which are classified from 0 to 3 (behavior is severe). Moreover, each behavior is also rated that how much this behavior occurs, cause interruption in activity and how much a child become agitated when he was interrupted. Global score rating was used by calculating the scores of all the six subscales and total score was given in range of 1 to 100.'}], 'secondaryOutcomes': [{'measure': 'Jebsen Hand Function Test (JHFT)', 'timeFrame': '3 weeks', 'description': 'JHFT was used to evaluate the task performance of autistic children.JHFT has seven variants and time was recorded, in seconds, taken by children to complete these seven tasks. These seven tasks are writing, card turning, small common objects, simulated feeding, stacking, lifting large lightweight objects and lifting large heavy objects. These piece of work was first performed by the non-dominant hand then by the dominant hand and at the end time required during all the task was summed up in minutes'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Autism spectrum disorder', 'Physical therapy', 'Stereotypic behaviors', 'ASD', 'Repetitive behaviors', 'Aerobic exercises', 'Jogging', 'Ball exercises.'], 'conditions': ['Autism Spectrum Disorder']}, 'descriptionModule': {'briefSummary': 'Autism spectrum disorder (ASD) is a neurodevelopmental disorder manifesting stereotypic behaviors and problem in communication and social interaction. Different physical therapy interventions like aerobics help to improve recurrent behaviors and task performance of autistic children. This study was focused to see the effect of jogging on the stereotypic behaviors and task performance of autistic children. A single blinded randomized study was conducted on 38 autistic children, randomly allocated to two groups, performing jogging and ball exercises. Repetitive Behavior Scale-revised(RBS-R) and Jebsen Hand Function Test (JHFT) was used for assessment. Exercise was performed for 3 weeks and 4 sessions per week.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosed children of autism spectrum disorder (ASD) by experts\n2. Have recognized stereotypic behaviors\n3. Age 6 to 20 years\n4. Independent to walk\n5. Both genders\n6. Parent and teachers willing to give consent\n\nExclusion Criteria:\n\n1. Unable to understand commands\n2. Have co-morbidities like schizophrenia or ADHD\n3. Having respiratory or cardiovascular problems\n4. Severe ASD\n5. Lower limb injury and disability'}, 'identificationModule': {'nctId': 'NCT05067361', 'briefTitle': 'Effectiveness of Aerobic Exercises on the Autistic Children', 'organization': {'class': 'OTHER', 'fullName': 'University of Faisalabad'}, 'officialTitle': 'Effectiveness of Aerobic Exercises on the Stereotypic Behaviors and Task Performance of Autistic Children: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'TUF/DR/MSPP/173'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'interventionNames': ['Procedure: Aerobic Exercise', 'Procedure: Ball Exercises']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active control Group', 'interventionNames': ['Procedure: Ball Exercises']}], 'interventions': [{'name': 'Aerobic Exercise', 'type': 'PROCEDURE', 'description': 'Jogging was performed for 20 minutes. Jogging was performed by experimental group for 3 weeks and 4 sessions per week.', 'armGroupLabels': ['Experimental Group']}, {'name': 'Ball Exercises', 'type': 'PROCEDURE', 'description': 'Ball exercises like stability ball roll, stability ball hug, stability ball catching, ball throwing and ball tapping exercises were for 10 minutes. Ball exercises was performed by both groups for 3 weeks and 4 times per week .', 'armGroupLabels': ['Active control Group', 'Experimental Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38000', 'city': 'Faisalābad', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'University of Faisalabad'}], 'overallOfficials': [{'name': 'Dr Sidra Majeed;PT, MSPP', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Faisalabad'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Faisalabad', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physical Therapist', 'investigatorFullName': 'Dr Amna Ayub PT', 'investigatorAffiliation': 'University of Faisalabad'}}}}