Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:54 PM
Study NCT ID:
NCT06240156
Status:
COMPLETED
Last Update Posted:
2024-02-02
First Post:
2024-01-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study on Plantar Pressure Distribution, Gait Balance and Lower Back Pain in Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-25', 'studyFirstSubmitDate': '2024-01-25', 'studyFirstSubmitQcDate': '2024-01-25', 'lastUpdatePostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'plantar pressure', 'timeFrame': 'footpad intervention measures immediately, two weeks, four weeks, six weeks after intervention', 'description': 'The pedar® system, an accurate and reliable pressure distribution measuring system designed to monitor local loads between the foot and the shoe.'}, {'measure': 'static balance', 'timeFrame': 'footpad intervention measures immediately, two weeks, four weeks, six weeks after intervention', 'description': 'The Timed Up and Go (TUG) test is utilized to assess mobility. It is a simple evaluation that measures the speed at which you can stand up, walk 10 feet, turn around, walk back, and sit down.'}, {'measure': 'foot pain', 'timeFrame': 'footpad intervention measures immediately, two weeks, four weeks, six weeks after intervention', 'description': 'The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning.'}, {'measure': 'lower back pain', 'timeFrame': 'footpad intervention measures immediately, two weeks, four weeks, six weeks after intervention', 'description': 'The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning.'}, {'measure': 'daily life disturbance scales', 'timeFrame': 'footpad intervention measures immediately, two weeks, four weeks, six weeks after intervention', 'description': 'The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pregnancy, gait balance, foot pain, lower back pain'], 'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to understand women with low arched feet, flat feet, or BMI\\> 29 in the third trimester.', 'detailedDescription': 'The purpose of this study was to understand women with low arched feet, flat feet, or BMI\\> 29 in the third trimester. Compare the intervention measures of different foot pads immediately, two weeks, four weeks, and six weeks after the intervention Immediate and long-term benefits in relief of plantar pressure, dynamic and static balance, and lower back pain.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* able to understand and write Chinese\n* health and third trimester women\n* low arched feet or flat feet or BMI\\> 29\n\nExclusion Criteria:\n\n* Women with a medical record of back, foot, ankle, knee, musculoskeletal, or neuromuscular trauma or disease'}, 'identificationModule': {'nctId': 'NCT06240156', 'briefTitle': 'A Study on Plantar Pressure Distribution, Gait Balance and Lower Back Pain in Pregnant Women', 'organization': {'class': 'OTHER', 'fullName': 'National Taipei University of Nursing and Health Sciences'}, 'officialTitle': 'Effect of Insole Intervention on Plantar Pressure Distribution, Gait Balance and Lower Back Pain in Flatfoot Women During the Third Trimester', 'orgStudyIdInfo': {'id': '16-S-023-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3D arch pad design Insole group', 'description': "This study utilizes a custom-made arch support pad with a 3D three-dimensional design that is already available on the market (patent number I315187). Its arch support principle is designed using 3DBS (Three-Dimensional Biomechanics System - 3DBS), which can conform to the user's feet. In this type, the bottom layer provides an overall shock-absorbing function.", 'interventionNames': ['Other: 3D arch pad design Insole group']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'flat Insole group', 'description': 'General Insole without any special features', 'interventionNames': ['Other: flat Insole group']}], 'interventions': [{'name': '3D arch pad design Insole group', 'type': 'OTHER', 'description': "3D three-dimensional design that is already available on the market (patent number I315187). Its arch support principle is designed using 3DBS (Three-Dimensional Biomechanics System - 3DBS), which can conform to the user's feet.", 'armGroupLabels': ['3D arch pad design Insole group']}, {'name': 'flat Insole group', 'type': 'OTHER', 'description': 'General Insole without any special features', 'armGroupLabels': ['flat Insole group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '114', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Wan-Lin Pan', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Meei-Ling Gau, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'professor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taipei University of Nursing and Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'Wan-Lin Pan', 'investigatorAffiliation': 'National Taipei University of Nursing and Health Sciences'}}}}