Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-01-01 @ 2:54 AM
Study NCT ID:
NCT05769556
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2023-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect Of Brain Gym Exercises On Postural Stability In Children With Down Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004314', 'term': 'Down Syndrome'}], 'ancestors': [{'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-07', 'studyFirstSubmitDate': '2023-03-03', 'studyFirstSubmitQcDate': '2023-03-03', 'lastUpdatePostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postural Stability', 'timeFrame': '3 months', 'description': 'we will use\n\n* Single leg stance TEST (SLS)\n* Timed up and Go Test ( TUG)\n* Paediatric Balance Scale (PBS)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Brain Gym Exercises', 'Postural Stability'], 'conditions': ['Down Syndrome']}, 'descriptionModule': {'briefSummary': 'This study will be conducted to detect the effect of brain gym exercises on postural stability in children with down syndrome .', 'detailedDescription': 'Evaluation procedures:\n\nHistory of the patients was carefully taken to collect data about their general conditions, physical activity and current medication. The procedures of this study were divided in the following main parts:\n\n-Preparatory Procedures:\n\n* All medical and demographic data of subjects will be collected\n* The role of physical therapy importance in improving their life will be explained.\n* The basic vital signs of all patients will be monitored (BP, temperature, respiratory rate, and HR).\n* The patients will be instructed to report any side effects during the treatment sessions .\n\nexplained to the children and to their parents, before conducting the study. All the participants were screened (examined) according to inclusion and exclusion criteria. then met the parents of the participants, told them about the study, and received a written approval from them .\n\nAll the children were firstly screened for balance deficit (static , dynamic and functional balance) by using\n\n* Single leg stance Test (SLS) for static balance assessment\n* Timed up and Go Test (TUG) for dynamic balance assessment\n* Paediatric Balance Scale (PBS) for functional balance assessment\n\n * the assessment and the treatment program, were conducted for each child individually, before and after the treatment period.\n\nassessment :\n\n* Single leg stance Test (SLS) for static balance assessment\n* Timed up and Go Test (TUG) for dynamic balance assessment\n* Paediatric Balance Scale (PBS) for functional balance assessment\n\nTTT :\n\nGroup A will receive brain gym exercises and physiotherapy, while Group (B) will receive physiotherapy alone.\n\nbrain gym exercises will be applied for 12 weeks , 3 per week .\n\nTherapist Will ask the child to drink a cup of water ,then investigators apply these exercises :\n\nCross Crawl - Elephant - Belly breathing -The owl - Arm activation -positive points - Energizer - foot flex - neck rolls -the grounder -Brain Buttons -Hook Up Sitting position - Thinking Caps- Lazy Eights - The Rocker-Calf pump - The gravity glider exercise.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\-\n\nChild characteristics:\n\n* Their age ranged from six to twelve years.\n* Both genders will be included.\n* ALL children were mentally sub-normal and they were able to understand the command that will give to them (IQ ranged from 60 - 70) according to the national research centre reports.\n* Their weight and height will be within normal ranges.\n* They were able to stand on the balance check system and maintain stability on it.\n\nExclusion Criteria:\n\nhildren with DS, who might have one or more of the following will be excluded:\n\n* Children with severe mental retardation.\n* Children who have any associated disorders or any congenital abnormalities that may affect balance.\n* Children with visual defects that can affect their performance.\n* Obese children.'}, 'identificationModule': {'nctId': 'NCT05769556', 'briefTitle': 'Effect Of Brain Gym Exercises On Postural Stability In Children With Down Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Kafrelsheikh University'}, 'officialTitle': 'Effect Of Brain Gym Exercises On Postural Stability In Children With Down Syndrome', 'orgStudyIdInfo': {'id': 'EG, KFS lab Research7'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'will receive brain gym exercises and physiotherapy .', 'interventionNames': ['Other: Brain Gym Exercises']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group (B)', 'description': 'will receive physiotherapy alone.', 'interventionNames': ['Other: Traditional physiotherapy']}], 'interventions': [{'name': 'Brain Gym Exercises', 'type': 'OTHER', 'description': 'Brain gym exercises is a collection of simple movements that function to stimulate the development of all parts of the brain synergistically.', 'armGroupLabels': ['Group A']}, {'name': 'Traditional physiotherapy', 'type': 'OTHER', 'description': 'A Group of exercises', 'armGroupLabels': ['Group (B)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kafr ash Shaykh', 'state': 'Kafrelshiekh', 'country': 'Egypt', 'facility': 'Physical Therapy', 'geoPoint': {'lat': 31.11174, 'lon': 30.93991}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aliaa Altohamy Goda', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Effect Of Brain Gym Exercises On Postural Stability In Children With Down Syndrome', 'investigatorFullName': 'Aliaa Altohamy Goda', 'investigatorAffiliation': 'Kafrelsheikh University'}}}}