Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-03-10 @ 4:15 AM
Study NCT ID:
NCT05917457
Status:
COMPLETED
Last Update Posted:
2025-03-27
First Post:
2023-05-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of the Effects of Balance Coordination and Strengthening Training on Gait, Mobility and Posture in Children with Low Vision
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015354', 'term': 'Vision, Low'}], 'ancestors': [{'id': 'D014786', 'term': 'Vision Disorders'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'they knew which groups they were in and the researcher knew where they were too.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Criteria for Inclusion of Volunteers in the Study and Control Group in the Research:\n\nto be in the age of 7-14, Except for visual impairment (neurological and systemic diseases, hearing impairment, etc. ) not having an additional disease October, Having been diagnosed with low vision, To be able to establish cooperation, Volunteering to participate in the study The 25 individuals who met the inclusion criteria were divided into 2 groups, including 13 in the study group and 12 in the control group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2023-05-29', 'studyFirstSubmitQcDate': '2023-06-15', 'lastUpdatePostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of motor competence', 'timeFrame': '8 weeks', 'description': 'The Bruininks- Oseretsky Motor Proficiency Test Short Form was used to evaluate motor competence in the cases.'}, {'measure': 'posture analysis', 'timeFrame': '8 weeks', 'description': 'New York Posture Analysis was used to evaluate postures of the cases.'}, {'measure': 'muscle strength assessment', 'timeFrame': '8 weeks', 'description': 'The Lovett method was used for the muscle strength'}, {'measure': 'Evaluation of Walking Parameters', 'timeFrame': '8 weeks', 'description': 'G-Walk system was used'}, {'measure': 'Mobility Level Assessment', 'timeFrame': '8 weeks', 'description': 'Independent Mobility Questionnaire (IMQ) was used'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Low vision', 'visually impaired', 'balance', 'strength training', 'walking'], 'conditions': ['Children with Low Vision']}, 'descriptionModule': {'briefSummary': 'The aim of this research is to examine and evaluate the effects of balance coordination and strengthening training on gait, mobility and posture in children with low vision\n\nThe hypotheses of our study:\n\nH1: Balance coordination and strengthening training has an effect on gait, mobility and posture in children with low vision.\n\nH2: Balance coordination and strengthening training has no effect on gait, mobility and posture in children with low vision.', 'detailedDescription': 'The aim of this study is to examine and evaluate the effects of balance coordination and strengthening training on gait, mobility and posture in children with low vision.\n\nA total of 22 low-vision individuals were included in the study. Individuals were randomly divided into two groups as Control (n=10) and Study (n=12). The treatment group received 70 min balance (20 min), coordination (20 min) and strengthening (20 min) training 3 days a week for 8 weeks. No additional treatment was applied to the control group. Evaluations were performed before treatment and at the end of 8 weeks.\n\nIn the evaluations; Bruininks-Oseretsky Motor Proficiency Test 2 Short Form (BOT2- KF), New York Posture Analysis, Manual November muscle strength assessment, G-Walk Gait Analysis, Independent Mobility Questionnaire (BMA) were used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* To be in the age December of 7-14,\n* Except for visual impairment (neurological and systemic diseases, hearing impairment, etc. ) not having an additional disease,\n* Having been diagnosed with low vision,\n* To be able to establish cooperation,\n* Volunteering to participate in the study\n\nExclusion Criteria:\n\n* Not being diagnosed with low vision,\n* Except for visual impairment (neurological and systemic diseases, hearing impairment, etc. ) having an additional disease,\n* Not volunteering to participate in the study'}, 'identificationModule': {'nctId': 'NCT05917457', 'briefTitle': 'Investigation of the Effects of Balance Coordination and Strengthening Training on Gait, Mobility and Posture in Children with Low Vision', 'organization': {'class': 'OTHER', 'fullName': 'Pamukkale University'}, 'officialTitle': 'Investigation of the Effects of Balance Coordination and Reinforcement Training on Gait, Mobility and Posture in Children with Low Vision', 'orgStudyIdInfo': {'id': 'Children with Low Vision'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'treatment group', 'description': 'to be in the age of 7-14, Except for visual impairment (neurological and systemic diseases, hearing impairment, etc. ) not having an additional disease Having been diagnosed with low vision, To be able to establish cooperation, Volunteering to participate in the study 12 children with these criteria', 'interventionNames': ['Other: balance coordination and strengthening training']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'to be in the age of 7-14, Except for visual impairment (neurological and systemic diseases, hearing impairment, etc. ) not having an additional disease, Having been diagnosed with low vision, To be able to establish cooperation, Volunteering to participate in the study 10 children with these criteria'}], 'interventions': [{'name': 'balance coordination and strengthening training', 'type': 'OTHER', 'description': 'The 25 individuals who met the inclusion criteria were divided into 2 groups, including 13 in the study group and 12 in the control group.\n\nStudy group: Low vision children were given balance, coordination training and general strengthening training with sandbags for 70 minutes 3 days a week (5-minute warm-up phase, 20-minute balance training, 20-minute coordination training, 20-minute strengthening training and 5-minute cooling phase) for 8 weeks.', 'armGroupLabels': ['treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20000', 'city': 'Denizli', 'state': 'Pamukkale', 'country': 'Turkey (Türkiye)', 'facility': 'Kınıklı Campus, Üniversite St. No:11 20160 Pamukkale / DENİZLİ', 'geoPoint': {'lat': 37.77417, 'lon': 29.0875}}], 'overallOfficials': [{'name': 'ERDOĞAN KAVLAK', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pamukkale University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'July 2022-June 2023', 'ipdSharing': 'YES', 'description': '1. Treatment group: Children with low vision will be given balance, coordination training and strengthening with sandbags for 75 minutes 3 days a week, for 8 weeks.\n2. Control Group: No training will be given except for evaluations.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pamukkale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physiotherapist Server ERDOĞMUŞ', 'investigatorFullName': 'Server ERDOĞMUŞ', 'investigatorAffiliation': 'Pamukkale University'}}}}