Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-02-28 @ 3:31 AM
Study NCT ID:
NCT06353867
Status:
COMPLETED
Last Update Posted:
2024-04-09
First Post:
2024-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Group Exercise in Children With Special Needs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002658', 'term': 'Developmental Disabilities'}, {'id': 'D001321', 'term': 'Autistic Disorder'}], 'ancestors': [{'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-03', 'studyFirstSubmitDate': '2024-04-03', 'studyFirstSubmitQcDate': '2024-04-03', 'lastUpdatePostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bruininks-Oseretsky Motor Competence Test Short Form Balance Subtest (Balance Subtest of BOT 2-KF)', 'timeFrame': 'Baseline and after the interventions (4th week)', 'description': '1. Standing on the dominant leg on the balance board: The participant will be asked to stand on the balance board with his/her eyes open on his/her dominant foot, looking at the target, with his/her hands on his/her waist and the other leg parallel to the ground for 10 seconds. Scoring will be recorded as 0-0.9 s 0 points, 1-2.9 s 1 point, 3-5.9 s 2 points, 6-9.9 s 3 points and 10 s 4 points according to the duration of standing on one leg.\n2. Tandem (heel-thumb) walking on the walking line: The participant will be asked to place his/her hands on his/her waist and walk along the walking line. When 6 steps are completed, the test is stopped. Steps that does not go beyond the line are evaluated. Scoring is done as 0 step 0 points, 1-2 steps 1 point, 3-4 steps 2 points, 5 steps 3 points and 6 steps 4 points.'}, {'measure': 'Paediatric Balance Scale', 'timeFrame': 'Baseline and after the interventions (4th week)', 'description': 'The version consisting of 14 sections and each section scored between 0-4 is used to evaluate the balance status of the participants.'}, {'measure': 'Functional Reach Test', 'timeFrame': 'Baseline and after the interventions (4th week)', 'description': 'The participant is asked to reach as far as he/she can horizontally at the level of a tape measure fixed to the wall with arms at 90 flexion. The test is repeated 3 times and the measurements are averaged.'}, {'measure': 'Timed Up and Go Test', 'timeFrame': 'Baseline and after the interventions (4th week)', 'description': 'It will be applied to assess balance and functional ambulation. The participant is asked to get up from a chair, walk 3 metres, turn around and sit down again. The time it took to complete the test will be recorded.'}, {'measure': 'Stroop Test', 'timeFrame': 'Baseline and after the interventions (4th week)', 'description': "The Stroop Test is among the neuropsychological tests frequently used to assess attention level and executive functions in children. Participants' time to complete the test is recorded."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['developmental disability', 'balance', 'attention', 'group exercise'], 'conditions': ['Developmental Disability', 'Child Autism']}, 'descriptionModule': {'briefSummary': "Thirty children with special needs were included in the study. Participants engaged in group exercises twice a week for four weeks, including warm-up and cool-down periods, with the goal of improving balance. The participants' balance was assessed using the Bruininks-Oseretsky Motor Proficiency Test Short Form (Balance Parameters), Pediatric Balance Scale; functional mobility was evaluated using the Timed Up and Go Test, and attention level was assessed using the Stroop Test before and after the intervention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 6-15 years with special needs\n* Able to walk independently\n\nExclusion Criteria:\n\n* Children with visual problems,\n* Any orthopaedic, rheumatic or neurological problems affecting balance,\n* Any contraindication to exercise'}, 'identificationModule': {'nctId': 'NCT06353867', 'briefTitle': 'The Effect of Group Exercise in Children With Special Needs', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Gedik University'}, 'officialTitle': 'The Effect of Group Exercise on Balance and Attention Level in Children With Special Needs', 'orgStudyIdInfo': {'id': '56365223-050.01.04-2023.13754'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group Exercise', 'interventionNames': ['Other: Group Exercise']}], 'interventions': [{'name': 'Group Exercise', 'type': 'OTHER', 'description': 'The children with special needs included in the study were included in group exercises for 45 minutes 2 days a week in groups of 10 children each. Group exercises were planned as balance and coordination exercises including warm-up and cool-down periods. In the warm-up and cool-down periods, counting in place and balance exercises were performed. The exercises included tasks such as side walking, tandem walking, walking on a balance board, walking in a figure 8, walking over obstacles, throwing a ball to the person next to him/her while passing through cones, and throwing a ball by jumping while passing through cones.The exercises were made more difficult by following a progressive method every 2 weeks. The exercises were performed in 3 sets of 5 repetitions under the supervision of a physiotherapist.', 'armGroupLabels': ['Group Exercise']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Marmara University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Gokce Kartal, PT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Marmara University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Gedik University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MSc,PT', 'investigatorFullName': 'Gokce Kartal', 'investigatorAffiliation': 'Istanbul Gedik University'}}}}