Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-29 @ 9:27 AM
Study NCT ID:
NCT07068360
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-16
First Post:
2025-07-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development and Validation of MPF to Prevent and Mitigate Postural Hyperkyphosis in Postmenopausal Women
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': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-07', 'studyFirstSubmitDate': '2025-07-07', 'studyFirstSubmitQcDate': '2025-07-07', 'lastUpdatePostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Cobb's Angle", 'timeFrame': '18 Months', 'description': "Cobb's Angle is a radiographic measurement used to assess spinal curvature in conditions like hyperkyphosis and scoliosis. It is calculated by identifying the most tilted vertebrae at the top and bottom of the curve on an X-ray. Straight lines are drawn along their endplates, and perpendiculars from these lines intersect to form the Cobb's Angle. A normal thoracic kyphosis ranges from 20° to 40°, while angles exceeding 40° in adults or 50° in postmenopausal women indicate hyperkyphosis. Severe cases (\\>60°) may require medical intervention. Regular follow-ups help monitor treatment effectiveness in reducing spinal curvature."}, {'measure': 'Timed Up and Go (TUG) Test', 'timeFrame': '18 Months', 'description': 'The TUG test assesses mobility, balance, and fall risk in older adults. The patient starts seated in a chair, stands up, walks 3 meters (10 feet), turns around, walks back, and sits down. The time taken to complete the task is recorded in seconds. A score of \\<10 seconds indicates normal mobility, 10-20 seconds suggests mild mobility impairment, and \\>30 seconds signifies a high fall risk and functional dependence. It is a simple, reliable tool commonly used in rehabilitation settings.'}, {'measure': 'Berg Balance Scale (BBS)', 'timeFrame': '18 Months', 'description': 'The BBS is a 14-item test used to assess balance and fall risk in older adults and neurological patients. Each task, such as standing on one foot or reaching forward, is scored from 0 to 4, with a total score of 56. A score of 41-56 indicates low fall risk, 21-40 suggests moderate risk, and ≤20 signifies a high risk of falls. The test is widely used due to its strong reliability and validity in clinical practice.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hyperkyphosis']}, 'descriptionModule': {'briefSummary': 'Postural hyperkyphosis is common in postmenopausal women and leads to spinal dysfunction, pain, impaired balance, and increased fall risk. This study aims to develop and validate a multimodal physiotherapy framework to prevent and manage hyperkyphosis in this population. A randomized controlled trial will be conducted at Allied Hospital with 72 postmenopausal women aged 40-75 years, divided into intervention (multimodal physiotherapy with conventional care) and control (conventional care only) groups.', 'detailedDescription': "The intervention includes strength, flexibility, postural correction, and balance training. The primary outcome is the change in Cobb's angle measured via radiographs; secondary outcomes include functional mobility and balance assessments using the Timed Up and Go Test, Berg Balance Scale, and Functional Reach Test. Data will be analyzed using SPSS v26. The study is expected to show significant improvements in spinal alignment, strength, balance, and reduced fall risk. The framework may offer a cost-effective, evidence-based approach for clinical and community rehabilitation"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Postmenopausal women aged 50-70 years.\n* Kyphotic angle ≥40°, as measured by a flexicurve ruler or radiographic assessment.\n* Postmenopausal for at least one year.\n* Able to engage in rehabilitation exercises and follow instructions for physical activity..\n* Living independently and capable of attending regular physiotherapy sessions.\n\nExclusion Criteria:\n\n* Uncontrolled comorbidities such as cardiovascular disease, neurological disorders stroke or Parkinson's), or severe musculoskeletal conditions (e.g., advanced arthritis )\n* History of spinal surgery within the last 6 months or spinal surgical implants. Severe osteoporosis (T-score \\< -2.5) and a history of multiple fractures.\n* Pregnant or breastfeeding women. Cognitive impairments or mental health disorders that hinder adherence to the intervention.\n* Inability to perform the exercises due to pain or disability.\n* Participation in other rehabilitation or physiotherapy interventions for postural hyperkhyposis"}, 'identificationModule': {'nctId': 'NCT07068360', 'briefTitle': 'Development and Validation of MPF to Prevent and Mitigate Postural Hyperkyphosis in Postmenopausal Women', 'organization': {'class': 'OTHER', 'fullName': 'Superior University'}, 'officialTitle': 'Development and Validation of a Multimodal Physiotherapy Framework to Prevent and Mitigate Postural Hyperkyphosis in Postmenopausal Women: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'PhDRSW/Batch-Fall23/2224'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Strength Training +Postural Correction Exercises + Balance Training +Flexibility Exercises', 'interventionNames': ['Combination Product: Strength Training +Postural Correction Exercises + Balance Training +Flexibility Exercises']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Intervention (Control Group)', 'interventionNames': ['Diagnostic Test: Standard Intervention (Control Group)']}], 'interventions': [{'name': 'Strength Training +Postural Correction Exercises + Balance Training +Flexibility Exercises', 'type': 'COMBINATION_PRODUCT', 'description': 'Interventions details (Group A) Strength Training Postural Correction Exercises Balance Training Exercises\n\nFlexibility Exercises:', 'armGroupLabels': ['Strength Training +Postural Correction Exercises + Balance Training +Flexibility Exercises']}, {'name': 'Standard Intervention (Control Group)', 'type': 'DIAGNOSTIC_TEST', 'description': 'The control group will receive standard physiotherapy for postural hyperkyphosis.\n\nThe standard intervention will consist of:\n\nPostural education: Educating participants on proper posture, body mechanics, and ergonomics in daily activities.\n\nBasic stretching exercises targeting the thoracic spine and back muscles. Recommendations for low-impact aerobics activities (e.g., walking or cycling) to promote overall healthThe standard intervention will be delivered over the same 12-week period, with two sessions per week. This group will not receive the integrated multimodal framework with strength training, postural correction, balance training, and flexibility exercises that the experimental group receives. Duration and Frequency', 'armGroupLabels': ['Standard Intervention (Control Group)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Faisalābad', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Faisalabad Medical University (Allied Hospital Faisalabad)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Superior University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Muhammad Naveed Babur', 'investigatorAffiliation': 'Superior University'}}}}