Ignite Creation Date:
2025-12-26 @ 2:42 PM
Ignite Modification Date:
2025-12-26 @ 2:42 PM
Study NCT ID:
NCT05853406
Status:
RECRUITING
Last Update Posted:
2024-11-05
First Post:
2023-05-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Determination of a Minimal Clinically Important Difference of the "Functional Reach Test" in the Elderly.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-04', 'studyFirstSubmitDate': '2023-05-01', 'studyFirstSubmitQcDate': '2023-05-09', 'lastUpdatePostDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional Reach Test', 'timeFrame': '1 year', 'description': 'Determination of MCID by statistical method'}], 'secondaryOutcomes': [{'measure': 'Functional Reach Test', 'timeFrame': '1 year', 'description': 'Determination of MCID by Patient rating of change'}, {'measure': 'Functional Reach Test', 'timeFrame': '1 year', 'description': 'Determination of MCID by Delphy Study'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aging']}, 'referencesModule': {'references': [{'pmid': '30593986', 'type': 'BACKGROUND', 'citation': 'Rosa MV, Perracini MR, Ricci NA. Usefulness, assessment and normative data of the Functional Reach Test in older adults: A systematic review and meta-analysis. Arch Gerontol Geriatr. 2019 Mar-Apr;81:149-170. doi: 10.1016/j.archger.2018.11.015. Epub 2018 Dec 7.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of the study is to determine the Minimal Clinically Important Difference of the "Functional Reach Test" in the Elderly by a statistical method.\n\nThe first secondary objective of the study is to determine the Minimal Clinically Important Difference by the Anchor method based on a qualitative assessment by the patients of their own response. The second secondary objective is to determine the Minimal Clinically Important Difference by the Delphi method, based on the search for a consensus between physiotherapists specializing in geriatrics.', 'detailedDescription': 'The French population is aging, and geriatric rehabilitation care must adapt to this growing population. The functional reach test is a common clinical test in geriatrics. It helps to determine the risk of falling. However, its metrological qualities are not all determined. The Minimal Clinically Important Difference (MCID) is in particular unknown for this test. The MCID of a test makes it possible to personalize in a way more in-depth evaluation of physiotherapy treatment. So it is necessary to characterize this essential metrological determinant of a common balance skills assessment tool.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The subjects recruited are patients aged over 65, having balance problems.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* People over 65 years old\n* People in care with balance problems\n\nExclusion Criteria:\n\n* People in an emergency situation\n* People unable to give their consent (including people under guardianship)\n* Patients already involved in another study.'}, 'identificationModule': {'nctId': 'NCT05853406', 'briefTitle': 'Determination of a Minimal Clinically Important Difference of the "Functional Reach Test" in the Elderly.', 'organization': {'class': 'OTHER', 'fullName': 'Pole Sante Grace de Dieu'}, 'officialTitle': 'Determination of a Minimal Clinically Important Difference of the "Functional Reach Test" in the Elderly.', 'orgStudyIdInfo': {'id': '20230102'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Functional Reach test', 'type': 'DIAGNOSTIC_TEST', 'description': 'The determination by statistical research is carried out during a usual physiotherapy assessment of the volunteers. Data patient demographics and standard tests (FRT, Tinetti test, Timed Up and Go test, unipodal station) will be noted.\n\nA satisfaction questionnaire inspired by Patient rating of change will be sent to participants for the determination of the MCID by ANCHOR method.\n\nConcerning the Delphi method, a questionnaire will be sent to physiotherapists with proven geriatric activity.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '14000', 'city': 'Caen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Guillaume GALLIOU', 'role': 'CONTACT', 'email': 'guillaume.galliou@gmail.com', 'phone': '0231834802'}], 'facility': 'PSLA GDD', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}], 'centralContacts': [{'name': 'Guillaume GALLIOU, MSc', 'role': 'CONTACT', 'email': 'guillaume.galliou@gmail.com', 'phone': '0231834802'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pole Sante Grace de Dieu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}