Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT04620993
Status:
COMPLETED
Last Update Posted:
2022-01-20
First Post:
2020-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Biomechanical and Viscoelastic Properties of Plantar Fascia in Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059388', 'term': 'Pelvic Girdle Pain'}], 'ancestors': [{'id': 'D059352', 'term': 'Musculoskeletal Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017699', 'term': 'Pelvic Pain'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2021-05-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-19', 'studyFirstSubmitDate': '2020-11-03', 'studyFirstSubmitQcDate': '2020-11-03', 'lastUpdatePostDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of biomechanical and viscoelastic properties of plantar fascia', 'timeFrame': 'Baseline Measurements', 'description': 'Measuring of the biomechanical and viscoelastic properties of the plantar fascia (with MyotonPro, Myoton AS, Tallin, Estonia) in the side lying position.'}, {'measure': 'Evaluation of plantar pressure distrubution', 'timeFrame': 'Baseline Measurements', 'description': 'Measuring of plantar pressure distrubution (with Tekscan, Boston, MA, USA) in free standing position'}], 'secondaryOutcomes': [{'measure': 'Evaluation of navicular drop', 'timeFrame': 'Baseline Measurements', 'description': 'Measuring of the amount of the navicular drop'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pelvic girdle pain, pregnant women, plantar fascia'], 'conditions': ['Pelvic Girdle Pain', 'Biomechanical and Viscoelastic Properties of Plantar Fascia', 'Pregnant Woman']}, 'referencesModule': {'references': [{'pmid': '31065537', 'type': 'BACKGROUND', 'citation': 'Park SY, Park DJ. Comparison of Foot Structure, Function, Plantar Pressure and Balance Ability According to the Body Mass Index of Young Adults. Osong Public Health Res Perspect. 2019 Apr;10(2):102-107. doi: 10.24171/j.phrp.2019.10.2.09.'}, {'pmid': '27406174', 'type': 'RESULT', 'citation': 'Elden H, Gutke A, Kjellby-Wendt G, Fagevik-Olsen M, Ostgaard HC. Predictors and consequences of long-term pregnancy-related pelvic girdle pain: a longitudinal follow-up study. BMC Musculoskelet Disord. 2016 Jul 12;17:276. doi: 10.1186/s12891-016-1154-0.'}, {'pmid': '28544276', 'type': 'RESULT', 'citation': 'Bertuit J, Van Lint CE, Rooze M, Feipel V. Pregnancy and pelvic girdle pain: Analysis of pelvic belt on pain. J Clin Nurs. 2018 Jan;27(1-2):e129-e137. doi: 10.1111/jocn.13888. Epub 2017 Nov 3.'}, {'pmid': '28880594', 'type': 'RESULT', 'citation': "Kerbourc'h F, Bertuit J, Feipel V, Rooze M. Pregnancy and Pelvic Girdle PainAnalysis of Center of Pressure During Gait. J Am Podiatr Med Assoc. 2017 Jul;107(4):299-306. doi: 10.7547/15-087."}, {'pmid': '22310881', 'type': 'RESULT', 'citation': 'Aldabe D, Ribeiro DC, Milosavljevic S, Dawn Bussey M. Pregnancy-related pelvic girdle pain and its relationship with relaxin levels during pregnancy: a systematic review. Eur Spine J. 2012 Sep;21(9):1769-76. doi: 10.1007/s00586-012-2162-x. Epub 2012 Feb 4.'}, {'pmid': '29146651', 'type': 'RESULT', 'citation': 'Ceprnja D, Chipchase L, Gupta A. Prevalence of pregnancy-related pelvic girdle pain and associated factors in Australia: a cross-sectional study protocol. BMJ Open. 2017 Nov 15;7(11):e018334. doi: 10.1136/bmjopen-2017-018334.'}, {'pmid': '30142609', 'type': 'RESULT', 'citation': 'Wuytack F, Daly D, Curtis E, Begley C. Prognostic factors for pregnancy-related pelvic girdle pain, a systematic review. Midwifery. 2018 Nov;66:70-78. doi: 10.1016/j.midw.2018.07.012. Epub 2018 Aug 8.'}, {'pmid': '22718046', 'type': 'RESULT', 'citation': 'Aldabe D, Milosavljevic S, Bussey MD. Is pregnancy related pelvic girdle pain associated with altered kinematic, kinetic and motor control of the pelvis? A systematic review. Eur Spine J. 2012 Sep;21(9):1777-87. doi: 10.1007/s00586-012-2401-1. Epub 2012 Jun 21.'}, {'pmid': '16621569', 'type': 'RESULT', 'citation': 'Khamis S, Yizhar Z. Effect of feet hyperpronation on pelvic alignment in a standing position. Gait Posture. 2007 Jan;25(1):127-34. doi: 10.1016/j.gaitpost.2006.02.005. Epub 2006 Apr 18.'}]}, 'descriptionModule': {'briefSummary': 'Pelvic girdle pain is frequently experienced in pregnant women and the mechanism of pelvic girdle pain is not known exactly. The aim of this study is to investigate the effect of biomechanical and viscoelastic properties of plantar fascia on pelvic girdle pain in pregnant women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pegnant women with pelvic girdle pain Pegnant women without pelvic girdle pain Non pregnant healthy women', 'genderDescription': 'Pegnant women with pelvic girdle pain Pegnant women without pelvic girdle pain Non pregnant healthy women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women in the 2nd or 3rd trimester of pregnancy with pelvic girdle pain\n* Pregnant women in the 2nd or 3rd trimester of pregnancy without pelvic girdle pain\n* First pregnancy\n* 20-40 years old\n* Healthy woman without pregnancy\n\nExclusion Criteria:\n\n* Participant having any kind of connective tissue disease\n* Presence of orthopedic or neurological problems in the lower extremities that may cause musculoskeletal disorder and biomechanical alignment deviations\n* Presence of foot pain that started before pregnancy and lasts for more than 3 months\n* Presence of lumbar-pelvic pain that started before pregnancy and lasts for more than 3 months\n* Have had 2 or more births\n* Presence of multiple pregnancy (twins, triplets etc)\n* Presence of ankle-ankle fracture and operation history in the last 6 months'}, 'identificationModule': {'nctId': 'NCT04620993', 'briefTitle': 'Biomechanical and Viscoelastic Properties of Plantar Fascia in Pregnant Women', 'organization': {'class': 'OTHER', 'fullName': 'Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey'}, 'officialTitle': 'Investigation of the Effect of Biomechanical and Viscoelastic Properties of Plantar Fascia on Pelvic Girdle Pain in Pregnant Women', 'orgStudyIdInfo': {'id': '166'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1: pregnant women with pelvic girdle pain', 'description': 'This group will consist of pregnant women who are in the 2nd or 3rd trimester of pregnancy and have pelvic girdle pain.', 'interventionNames': ['Other: Evaluation of biomechanics and viscoelastic properties of plantar fascia', 'Other: Evaluation of navıcular drop', 'Other: Evaluation of plantar pressure distrubution']}, {'label': 'Group 2:pregnant women without pelvic girdle pain', 'description': 'This group will consist of pregnant women who are in the 2nd or 3rd trimester of pregnancy but have not pelvic girdle pain.', 'interventionNames': ['Other: Evaluation of biomechanics and viscoelastic properties of plantar fascia', 'Other: Evaluation of navıcular drop', 'Other: Evaluation of plantar pressure distrubution']}, {'label': 'Group 3: healthy women', 'description': 'This group will consist of healthy women who have not been pregnant.', 'interventionNames': ['Other: Evaluation of biomechanics and viscoelastic properties of plantar fascia', 'Other: Evaluation of navıcular drop', 'Other: Evaluation of plantar pressure distrubution']}], 'interventions': [{'name': 'Evaluation of biomechanics and viscoelastic properties of plantar fascia', 'type': 'OTHER', 'description': 'The biomechanical and viscoelastic properties of the plantar fascia will be measured in the side lying position.\n\nMeasurements will be made with the ankle in neutral position and maximum dorsi flexion position.', 'armGroupLabels': ['Group 1: pregnant women with pelvic girdle pain', 'Group 2:pregnant women without pelvic girdle pain', 'Group 3: healthy women']}, {'name': 'Evaluation of navıcular drop', 'type': 'OTHER', 'description': 'The amount of navicular drop of both feet will be measured', 'armGroupLabels': ['Group 1: pregnant women with pelvic girdle pain', 'Group 2:pregnant women without pelvic girdle pain', 'Group 3: healthy women']}, {'name': 'Evaluation of plantar pressure distrubution', 'type': 'OTHER', 'description': 'The distribution of foot plantar pressure and the amount of change in the center of gravity will be measured in the free standing position.', 'armGroupLabels': ['Group 1: pregnant women with pelvic girdle pain', 'Group 2:pregnant women without pelvic girdle pain', 'Group 3: healthy women']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Saglık Bilimleri University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}