Ignite Creation Date:
2025-12-24 @ 12:44 PM
Ignite Modification Date:
2026-01-01 @ 2:17 PM
Study NCT ID:
NCT05155761
Status:
UNKNOWN
Last Update Posted:
2023-06-07
First Post:
2021-09-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identifying Risk Factors for Falls in Patients With a High Risk of Fracture Using Connected Insoles (FeetMe Monitor® Device)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2024-11-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-06', 'studyFirstSubmitDate': '2021-09-15', 'studyFirstSubmitQcDate': '2021-11-30', 'lastUpdatePostDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess how a walking speed decrease at baseline during a 6MWT as measured by the connected Insoles, connected insoles devices, has an effect on risk of fall in subjects with osteoporosis.', 'timeFrame': 'at baseline', 'description': 'Assess walking speed decrease during 6MWT at baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['FeetMe', 'Insoles', 'Fall', 'Osteoporosis'], 'conditions': ['Fall', 'Fall Patients', 'Osteoporosis']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to determine which gait parameters measured at home using e FeetMe® Insoles are associated with a risk for falls in a patient population suffering from osteoporosis and a higher with high risk of fractures and falls.\n\nEach patient will be asked to go to 3 visits at the Cochin hospital, and to wear the soles after each of these visits during 3 days, at home, to record the data, so that it reflects walking patterns of the patient in his/her daily life and activities.\n\nAt the eachvisit, clinical tests to assess fall risk will be performed (Timed Up and Go test, one foot stance, Short Physical Performance Battery and 6 minutes walking test ).\n\nThe patients will be supplied with a pair of FeetMe® Monitor Insoles, return home and walking parameters will be recorded for 3 to 10 consecutive days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male and female subjects aged 60 years and above\n* with a high fracture and fall risk defined by osteoporosis (low-trauma fracture within the last 5 years and/or osteoporotic bone density)\n* a fall within the last year, who own a smartphone.\n\nExclusion Criteria:\n\n* cognitive deficit or concomitant disorder limiting communication or participation in the study\n* simultaneous participation in another study\n* deprivation of liberty due to a legal or administrative decision\n* patients receiving psychiatric care\n* adults beyond the age of majority under legal protection measures or unable to express their consent\n* patients admitted to a health or social establishment for reasons other than research.'}, 'identificationModule': {'nctId': 'NCT05155761', 'acronym': 'FAIR', 'briefTitle': 'Identifying Risk Factors for Falls in Patients With a High Risk of Fracture Using Connected Insoles (FeetMe Monitor® Device)', 'organization': {'class': 'INDUSTRY', 'fullName': 'FeetMe'}, 'officialTitle': 'Identifying Risk Factors for Falls in Patients With a High Risk of Fracture Using Connected Insoles (FeetMe Monitor® Device)', 'orgStudyIdInfo': {'id': 'FTM_FAIR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Osteoporotic patients', 'interventionNames': ['Device: FeetMe® Monitor']}], 'interventions': [{'name': 'FeetMe® Monitor', 'type': 'DEVICE', 'description': 'Each patient will be asked to go to 3 visits at the Cochin hospital, and to wear the soles after each of these visits during 3 days, at home, to record the data, so that it reflects walking patterns of the patient in his/her daily life and activities.\n\nAt each visit, clinical tests to assess fall risk will be performed (Timed Up and Go test, one foot stance, Short Physical Performance Battery and 6 minutes walking test ).\n\nThe patients will be supplied with a pair of FeetMe® Monitor insoles, return home and walking parameters will be recorded for 3 to 10 consecutive days.', 'armGroupLabels': ['Osteoporotic patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Karine Briot, Dr.', 'role': 'CONTACT', 'email': 'karine.briot@aphp.fr', 'phone': '01 58 41 26 06'}], 'facility': 'Service de Rhumatologie, Hôpital Cochin, Assistance Publique - Hôpitaux de', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'FeetMe', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}