Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-01-12 @ 1:17 PM
Study NCT ID:
NCT07205835
Status:
COMPLETED
Last Update Posted:
2025-10-03
First Post:
2025-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Analysis of Artificial Intelligence-Generated and Studio-Based Reformer Pilates Interventions for Forward Head Posture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study population consisted of a total of 40 male and female volunteers aged between 18 and 50 years with a craniovertebral angle of less than 54 degrees. Participants were randomized into two groups: the Clinical Pilates group and the ChatGPT group. The Clinical Pilates group (n=20) performed clinical Pilates exercises under the supervision of a physiotherapist for 6 weeks, twice a week, 50 minutes per session. The ChatGPT group (n=20) followed an exercise program generated by ChatGPT under the supervision of a physiotherapist for 6 weeks, twice a week, 50 minutes per session.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-26', 'studyFirstSubmitDate': '2025-09-26', 'studyFirstSubmitQcDate': '2025-09-26', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Craniovertebral Angle', 'timeFrame': 'Baseline and after 6 weeks', 'description': 'Craniovertebral angle will be measured using digital photography and goniometric analysis to evaluate postural improvement.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['posture', 'Pain', 'Artificial intelligence (AI)', 'Pilates exercises', 'Physiotherapy and rehabilitation'], 'conditions': ['Posture', 'Neck Disorder']}, 'descriptionModule': {'briefSummary': 'Posture is the alignment of body segments. While ideal posture places minimal stress on the joints, poor posture increases joint stress. Forward head posture (FHP) is a common postural abnormality characterized by the anterior displacement of the head in the sagittal plane. This condition may lead to muscle imbalances, pain, reduced cervical range of motion (ROM), decreased quality of life, and spinal degeneration.\n\nThe most common method for evaluating FHP is the craniovertebral angle (CVA). Causes of FHP include excessive smartphone and computer use, mouth breathing, carrying heavy bags, and rounded shoulders. Cervical stabilization exercises and holistic approaches are recommended for prevention and treatment.\n\nPilates, developed by Joseph Pilates, especially in its clinical form, has been shown to improve posture, strengthen core muscles, and enhance quality of life. Literature indicates that stretching- and strengthening-based exercise programs targeting FHP positively affect CVA, neck pain, and ROM.\n\nIn recent years, artificial intelligence (AI) has gained importance in physiotherapy as a diagnostic and therapeutic support tool. Its potential in generating exercise prescriptions is being explored, though whether AI can replace physiotherapists remains debated.\n\nThe aim of this study is to compare the effectiveness of an AI-generated reformer Pilates protocol and a studio-based reformer Pilates protocol in individuals with FHP. Hypotheses:\n\nH0: The studio-based reformer Pilates protocol has no effect on CVA, ROM, pain, muscle endurance, or quality of life in individuals with FHP.\n\nH1: The studio-based reformer Pilates protocol has a positive effect on these parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion Criteria:\n\nVolunteers aged between 18-50 years\n\nCraniovertebral angle less than 54°\n\nAbility to participate in exercise sessions twice a week for 6 weeks\n\nWillingness to provide informed consent\n\nExclusion Criteria:\n\nHistory of musculoskeletal, neurological, or cardiovascular disorders\n\nPrevious surgery affecting posture or spine\n\nCurrent participation in another structured exercise program\n\nPregnancy\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07205835', 'briefTitle': 'Comparative Analysis of Artificial Intelligence-Generated and Studio-Based Reformer Pilates Interventions for Forward Head Posture', 'organization': {'class': 'OTHER', 'fullName': 'Uskudar University'}, 'officialTitle': 'A Comparative Evaluation of the Effectiveness of an Artificial Intelligence-Generated Reformer Pilates Protocol and a Studio-Designed Reformer Pilates Protocol in Individuals With Forward Head Posture', 'orgStudyIdInfo': {'id': 'FZT2024/37'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clinical Pilates Group', 'description': 'Participants in this group will perform clinical Pilates exercises under the supervision of a physiotherapist, twice a week for 6 weeks. Each session will last 50 minutes and will include core stabilization, postural correction, and flexibility exercises.', 'interventionNames': ['Behavioral: Clinical Pilates Group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ChatGPT Exercise Group', 'description': 'Participants in this group will perform an exercise program generated by ChatGPT and supervised by a physiotherapist, twice a week for 6 weeks. Each session will last 50 minutes and will include exercises designed to improve posture, flexibility, and musculoskeletal function.', 'interventionNames': ['Behavioral: ChatGPT Exercise Group']}], 'interventions': [{'name': 'ChatGPT Exercise Group', 'type': 'BEHAVIORAL', 'description': 'Participants in the ChatGPT group will follow an exercise program generated by ChatGPT and supervised by a physiotherapist. The program will be delivered twice weekly for 6 weeks, with each 50-minute session including exercises designed to improve posture, flexibility, and musculoskeletal function.', 'armGroupLabels': ['ChatGPT Exercise Group']}, {'name': 'Clinical Pilates Group', 'type': 'BEHAVIORAL', 'description': 'Participants in this arm will perform supervised clinical Pilates exercises twice weekly for 6 weeks. Each session will last 50 minutes and include core stabilization, postural correction, and flexibility exercises.', 'armGroupLabels': ['Clinical Pilates Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34764', 'city': 'Istanbul', 'state': 'Ümraniye', 'country': 'Turkey (Türkiye)', 'facility': 'Üsküdar Üniversitesi NP Sağlık Yerleşkesi', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared. However, study results will be published in peer-reviewed scientific journals.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uskudar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asst. Prof.', 'investigatorFullName': 'Dr. Öğr. Üyesi Muhammed Fatih Kavak', 'investigatorAffiliation': 'Uskudar University'}}}}