Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2026-01-02 @ 8:47 AM
Study NCT ID:
NCT06730269
Status:
COMPLETED
Last Update Posted:
2024-12-12
First Post:
2024-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Face-to-Face Vs. Telerehabilitation for Thoracic Hyperkyphosis in Children: a Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007738', 'term': 'Kyphosis'}], 'ancestors': [{'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2023-12-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-11', 'studyFirstSubmitDate': '2024-12-06', 'studyFirstSubmitQcDate': '2024-12-11', 'lastUpdatePostDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Thoracic Kyphosis Angle (TKA)', 'timeFrame': '6 weeks', 'description': 'It was measured using a flexicurve ruler to assess the curvature of the thoracic spine before and after the intervention.\n\n\\>45° is considered hyperkyphosis'}, {'measure': 'Manual Muscle Test (MMT)', 'timeFrame': '6 weeks', 'description': 'Evaluates back muscle strength before and after the intervention. Minimum = 0 (no muscle contraction), Maximum = 5 (normal muscle strength).'}, {'measure': 'Visual Analog Scale (VAS)', 'timeFrame': '6 weeks', 'description': 'Assesses pain levels before and after the intervention. Minimum = 0 (no pain), Maximum = 10 (worst possible pain)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thoracic hyperkyphosis', 'face-to-face rehabilitation', 'telerehabilitation', 'spinal posture', 'musculoskeletal health', 'corrective exercises', 'Pediatric Kyphosis'], 'conditions': ['Kyphosis Thoracic', 'Hyperkyphosis']}, 'referencesModule': {'references': [{'pmid': '32330860', 'type': 'BACKGROUND', 'citation': 'Yang L, Lu X, Yan B, Huang Y. Prevalence of Incorrect Posture among Children and Adolescents: Finding from a Large Population-Based Study in China. iScience. 2020 May 22;23(5):101043. doi: 10.1016/j.isci.2020.101043. Epub 2020 Apr 8.'}, {'pmid': '28610442', 'type': 'BACKGROUND', 'citation': 'Feng Q, Wang M, Zhang Y, Zhou Y. The effect of a corrective functional exercise program on postural thoracic kyphosis in teenagers: a randomized controlled trial. Clin Rehabil. 2018 Jan;32(1):48-56. doi: 10.1177/0269215517714591. Epub 2017 Jun 14.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/28610442/', 'label': 'Related Info'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/32330860/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the effectiveness of face-to-face versus telerehabilitation programs for children aged 9-12 with thoracic hyperkyphosis, a condition caused by poor posture that leads to excessive forward curvature of the spine. Twenty children participated in a six-week corrective exercise program, either in person or through an online platform. Both approaches significantly improved spinal posture, back muscle strength, and pain levels, with no notable differences in outcomes between the two methods. The findings suggest that telerehabilitation is as effective as face-to-face rehabilitation, offering a flexible option for managing thoracic hyperkyphosis in children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '9 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 9-12 years.\n* Diagnosed with thoracic hyperkyphosis (Thoracic Kyphosis Angle \\> 40 degrees).\n* Able to participate in a 6-week rehabilitation program (face-to-face or telerehabilitation).\n\nExclusion Criteria:\n\n* Children with congenital spinal malformations.\n* Children with mental health issues that could interfere with participation or compliance in the study.'}, 'identificationModule': {'nctId': 'NCT06730269', 'briefTitle': 'Face-to-Face Vs. Telerehabilitation for Thoracic Hyperkyphosis in Children: a Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Medipol University'}, 'officialTitle': 'Comparative Efficacy of Face-to-Face and Telerehabilitation Approaches in Managing Thoracic Hyperkyphosis Among 9-12-Year-Olds: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'İMU-SEDAGOZENER-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Face-to-Face Rehabilitation Group', 'description': 'Participants in this arm received a thoracic corrective exercise program in person, consisting of four exercises targeting back extensor muscles. The exercises were performed three times a week for six weeks under the supervision of a trained therapist.', 'interventionNames': ['Behavioral: Face-to-Face Rehabilitation Program']}, {'type': 'EXPERIMENTAL', 'label': 'Telerehabilitation Group', 'description': 'Participants in this arm followed the same thoracic corrective exercise program, but the sessions were delivered online through the Fiziu platform. Exercises were performed three times a week for six weeks with remote guidance and monitoring.', 'interventionNames': ['Behavioral: Telerehabilitation Program']}], 'interventions': [{'name': 'Face-to-Face Rehabilitation Program', 'type': 'BEHAVIORAL', 'description': 'The Face-to-Face Rehabilitation Program is a structured rehabilitation regimen designed to improve posture, reduce pain, and strengthen back extensor muscles in children with thoracic hyperkyphosis. Participants in this group engaged in the Thoracic Corrective Exercise Program, which included four specific exercises targeting thoracic spine correction. The exercises were performed three times per week over six weeks, under the direct supervision of a trained therapist. This setup ensured real-time feedback, personalized adjustments, and guidance during each session, optimizing the effectiveness of the rehabilitation process.', 'armGroupLabels': ['Face-to-Face Rehabilitation Group']}, {'name': 'Telerehabilitation Program', 'type': 'BEHAVIORAL', 'otherNames': ['Fiziu Platform Video Based Exercise Group'], 'description': 'The Telerehabilitation Program is a structured rehabilitation regimen designed to improve posture, reduce pain, and strengthen back extensor muscles in children with thoracic hyperkyphosis. Participants in this group followed the Thoracic Corrective Exercise Program, which included four specific exercises targeting thoracic spine correction, performed three times per week over six weeks. The program was delivered remotely through the Fiziu platform, allowing therapists to provide virtual guidance, feedback, and monitoring during the sessions. This approach offered flexibility for families and ensured accessibility to rehabilitation services from the comfort of their homes.', 'armGroupLabels': ['Telerehabilitation Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'state': 'Kavacık', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Medipol University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Seda Gözener Canbülbül', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medipol University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medipol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD candidate', 'investigatorFullName': 'Seda GÖZENER CANBÜLBÜL', 'investigatorAffiliation': 'Medipol University'}}}}