Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT07023718
Status:
COMPLETED
Last Update Posted:
2025-06-17
First Post:
2023-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Pelvic Joint Stiffness on the Fear of Falling in Subjects Aged Over 75 Years
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000844', 'term': 'Ankylosis'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-10-14', 'size': 1035504, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-06-12T05:46', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-12', 'studyFirstSubmitDate': '2023-09-12', 'studyFirstSubmitQcDate': '2025-06-12', 'lastUpdatePostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Association between fear of falling and articular stiffness', 'timeFrame': 'At inclusion', 'description': 'The primary outcome is the association between joint stiffness and fear of falling:\n\n* Fear of falling assessed by FES-I (score).\n* Joint mobility assessed by Schober goniometry (degrees).\n* Joint mobility assessed by Schober index (centimeters).'}], 'secondaryOutcomes': [{'measure': 'Validity of 3 FES-I categories based on anthropometric measurements', 'timeFrame': 'At inclusion', 'description': 'Using the Falls Efficacy Scale - International (FES-I) questionnaire. It is an improved version of the Fall Efficacy Scale (FES) proposed by Tinetti (18). The FES-I was developed by the Prevention of Falls Network Europe (ProFaNE) group. It is available on the ProFaNE website. The scale includes 16 items, each scored from 1 (not at all concerned) to 4 (very concerned), resulting in a total score range from 16 to 64.\n\nFES-I scores are typically categorized as follows:\n\nLow concern: 16-19\n\nModerate concern: 20-27\n\nHigh concern: 28-64\n\nHigher scores indicate a worse outcome, reflecting a greater fear of falling and decreased confidence in performing daily activities safely.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pelvic joint;', 'fear of falling', 'ankylosis'], 'conditions': ['Fear of Falling', 'Pelvic Joint/Ligament Damage']}, 'descriptionModule': {'briefSummary': 'The pelvic girdle is the mechanical structure at the center of the balance and walking systems. The lack of amplitude of the joints that compose it could induce a fear of falling, common in the geriatric population and often underdiagnosed with poorly identified risk factors. This study seeks to highlight an association between fear of falling and lack of amplitude of the different joints of the pelvic girdle in order to identify predisposed patients and to set up preventive measures and better medical care.', 'detailedDescription': 'The pelvic girdle is the mechanical structure at the center of the balance and walking systems. The lack of amplitude of the joints that compose it could induce a fear of falling, common in the geriatric population and often underdiagnosed with poorly identified risk factors. Fear of falling is defined as the enduring preoccupation with falling, leading the person to avoid activities that they are capable of doing. It modifies its behavior and affects its quality of life, its well-being and increases the risk of developing pathologies linked to the lack of physical activities. Joint stiffness is a major disorder in the elderly linked to bone and joint aging, but also to lack of mobilization. The pelvic girdle is the mechanical structure at the center of the balance and gait systems. The lack of amplitude of the joints that compose it could induce a fear of falling.\n\nThis study seeks to highlight whether there is an association between the fear of falling and the lack of amplitude of the different joints of the pelvic girdle.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Male and Female Subjects aged over 75 years old being hospitalized or in institution.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects aged over 75 years hospitalized or in institution in the geriatric department of GHSIF (Groupe Hospitalier Sud -Ile-de France)\n\nExclusion Criteria:\n\n* Patients that have undergone a lumbar surgery\n* Patients with hospital diagnosed cognitive troubles'}, 'identificationModule': {'nctId': 'NCT07023718', 'acronym': 'RAAPC', 'briefTitle': 'Impact of Pelvic Joint Stiffness on the Fear of Falling in Subjects Aged Over 75 Years', 'organization': {'class': 'OTHER', 'fullName': 'Groupe Hospitalier Sud Ile-de-France'}, 'officialTitle': 'Study of a Cohort of 100 Patients on the Impact of Pelvic Joint Stiffness on the Fear of Falling in Subjects Aged Over 75 Years, Hospitalized or in Institution', 'orgStudyIdInfo': {'id': '2021-A01885-36'}}, 'contactsLocationsModule': {'locations': [{'zip': '77000', 'city': 'Brie-Comte-Robert', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'EHPAD Brie Comte Robert', 'geoPoint': {'lat': 48.69247, 'lon': 2.6109}}, {'zip': '77000', 'city': 'Melun', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Centre Hospitalier Melun', 'geoPoint': {'lat': 48.5457, 'lon': 2.65356}}], 'overallOfficials': [{'name': 'sylvie Aufaure, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Groupe Hospitalier Sud Ile-de-France'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Groupe Hospitalier Sud Ile-de-France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}