Ignite Creation Date:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2025-12-26 @ 12:16 PM
Study NCT ID:
NCT06318000
Status:
COMPLETED
Last Update Posted:
2024-03-20
First Post:
2024-03-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Physical Activity and Sports for People With Visual Impairments
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001766', 'term': 'Blindness'}, {'id': 'D014786', 'term': 'Vision Disorders'}], 'ancestors': [{'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-19', 'studyFirstSubmitDate': '2024-03-01', 'studyFirstSubmitQcDate': '2024-03-12', 'lastUpdatePostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Center of pressure (CoP) path length was measured', 'timeFrame': 'Baseline', 'description': 'CoP displacement analysis is used to assess postural sway, based on which the balance control function can be assessed'}, {'measure': 'Surface area of stabilogram was measured', 'timeFrame': 'Baseline', 'description': 'Based on the analysis of the surface area of the stabilogram, the level of balance control can be assessed'}, {'measure': 'Raw and scale score for each item', 'timeFrame': 'Baseline', 'description': "Based on this information, the level of bilateral coordination can be assessed. The assessment consists of 12 elements, with 6 aimed at assessing locomotion skills and the remaining 6 at object control skills. The locomotion component includes running, galloping, hopping, skipping, jumping, and sliding. The object control component includes striking stationary ball, stationary dribbling, catching, kicking, striking moving ball, and rolling ball. Each task is performed twice, with 1 point awarded for correct execution and 0 points for incorrect execution in every task's criteria. The total score from both trials indicates the final score for each task."}, {'measure': 'Qualitative performance criteria (points)', 'timeFrame': 'Baseline', 'description': "Based on this information, the level of fundamental motor skills level can be assessed. Raw score for each item was converted into point score rated on a scale of 0 to 3 or 4 points, in accordance to the study protocol, and the standardization of the test described in the manual of the BOT-2. The sum of raw scores from all the 7 items ranged from 0 to 24 points. The scale score was used to describe the examinee's level of proficiency on the subtest 4. Higher scores mean a better outcome."}], 'secondaryOutcomes': [{'measure': 'Body mass in kg', 'timeFrame': 'Baseline', 'description': 'body mass'}, {'measure': 'Body height in cm', 'timeFrame': 'Baseline', 'description': 'height'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Balance', 'Fundamental Motor Skills', 'Bilateral Coordination', 'Visual Impairments'], 'conditions': ['Blindness', 'Visual Impairment']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/33541039/', 'label': 'Role of vision in static balance in persons with and without visual impairments'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/30421870/', 'label': 'Description Effects of sport on static balance in athletes with visual impairments'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/31065548/', 'label': 'Test of Motor Proficiency Second Edition (BOT-2): Compatibility of the Complete and Short Form and Its Usefulness for Middle-Age School Children'}, {'url': 'https://sites.google.com/view/tgmd-3/home', 'label': 'Test of Gross Motor Development - 3'}]}, 'descriptionModule': {'briefSummary': "Purpose of this study was to assess the relationship between the visual impairment degree and the level of children's fundamental motor skills, balance and bilateral coordination.", 'detailedDescription': 'The participants were presented with the procedure of the study and informed that they could resign from their participation in the study at any stage. All participants legal guardians, were given the written informed consent form after the detailed written explanation of the risk and benefits resulting from participation in this study. Static balance was assessed using the portable AccuSway-Optimized (ACS-O) by AMTI stabilographic platform (ACS Model). The study participants performed the both feet 30 second, single 10 second left and right-leg stance with eyes open (EO), and both feet 30 second, left and right-leg stance with eyes closed (EC). If the first attempt was not successful, study participants were able to do the second attempt. The tests were conducted approximately 2 hours after a meal, in a sports outfit, in a specially designated room.\n\nThe functional assessment of locomotor skills will utilize the "locomotion" subtest, which is part of the Test of Gross Motor Development, Second Edition (TGMD-3) battery. In the selected "locomotion" subtest, the following movement tasks (locomotor skills) are assessed: Run, Gallop, Hop, Horizontal Jump, Skip, Slide.\n\nThe subtest 4 "Bilateral Coordination" of the Bruininks-Oseretsky Test of Motor Proficiency (BOT-2) was used in this study. The BOT-2 is an individually administered test that includes goal-directed activities to measure a wide range of motor skills in individuals aged 4 to 21 years. Participants performed seven items:\n\n1. Touching Nose with Index Fingers - Eyes Closed\n2. Jumping Jacks\n3. Jumping in Place - Same Sides Synchronized\n4. Jumping in Place - Opposite Sides\n5. Pivoting Thumbs and Index Fingers\n6. Tapping Feet and Fingers - Same Sides Synchronized\n7. Tapping Feet and Fingers - Opposite Sides'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '7 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants were 51 individuals with congenital or acguired visual impairments (26 girls and 25 boys) aged 7 to 17. The group of able-bodied peers consisted of 25 individuals (13 girls and 12 boys).', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* written consent form,\n* visual impairment (diagnosed)\n* intellectual norm.\n\nExclusion Criteria:\n\n* nervous system disorders,\n* structural changes within the musculoskeletal system\n* and intellectual limitations.'}, 'identificationModule': {'nctId': 'NCT06318000', 'briefTitle': 'Physical Activity and Sports for People With Visual Impairments', 'organization': {'class': 'OTHER', 'fullName': 'Józef Piłsudski University of Physical Education'}, 'officialTitle': "Assessment of the Relationship Between the Visual Impairment Degree and the Level of Children's Fundamental Motor Skills, Balance and Bilateral Coordination", 'orgStudyIdInfo': {'id': 'SN4/20/22'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Persons with visual impairments', 'description': 'Youth aged 7-17 years, male and female, with congenital or acquired visual impairment', 'interventionNames': ['Other: Balance test, bilateral coordination test, fundamental motor skills test']}, {'label': 'Able bodied persons', 'description': 'Youth aged 7-17 years, male and female, without impairments', 'interventionNames': ['Other: Balance test, bilateral coordination test, fundamental motor skills test']}], 'interventions': [{'name': 'Balance test, bilateral coordination test, fundamental motor skills test', 'type': 'OTHER', 'description': 'Functional assessment', 'armGroupLabels': ['Able bodied persons', 'Persons with visual impairments']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00-968', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'University of Physical Education', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'overallOfficials': [{'name': 'Natalia Morgulec - Adamowicz, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Józef Piłsudski University of Physical Education in Warsaw'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Józef Piłsudski University of Physical Education', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}