Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-03-26 @ 6:02 AM
Study NCT ID:
NCT03116204
Status:
COMPLETED
Last Update Posted:
2025-10-06
First Post:
2017-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of a SOFMER Activity Scale
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-01', 'studyFirstSubmitDate': '2017-04-11', 'studyFirstSubmitQcDate': '2017-04-11', 'lastUpdatePostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of the validity of SAS', 'timeFrame': 'Day 0', 'description': 'The construct validity will be determined by an exploratory factor analysis and confirmed on an independent sample.\n\nCriterion validity will be studied by comparison of scores obtained from SAS to scores obtained from references scale (FIM, WeeFIM, ADL, IADL, BREF, BREV, MMSE and items of WISC IV).'}, {'measure': 'Assessment of the reliability of SAS.', 'timeFrame': 'Day 7', 'description': 'For the inter rater reliability study, patients will be rated on the same day by two groups of therapists.\n\nFor the test-retest reliability study, patients will be rated twice during their hospitalization, within a time frame sufficiently close so that their dependency should not change.'}], 'secondaryOutcomes': [{'measure': 'Study of SAS responsiveness', 'timeFrame': '6 months', 'description': 'Sensitivity to change will be studied on patients hospitalized in a FRC departments for obesity, spinal cord injuries, post-stroke rehabilitation or cardiorespiratory rehabilitation after cardiac surgery. The change between scores of SAS at entry and exit (or at maximum 6 months after inclusion) of hospitalization will be studied.'}, {'measure': 'Study of invariance of SAS: invariance of the classification between age and sex classes.', 'timeFrame': 'day 0', 'description': 'Invariance of SAS will be determined between three age classes (\\<18 years, 18-75 years,\\> 75 years) using three confirmatory factor analyzes'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dependency', 'FRC department', 'scale validation', 'validity', 'reliability'], 'conditions': ['Patients Hospitalized in a FRC Department']}, 'descriptionModule': {'briefSummary': "A person's dependency is defined as the total or partial inability to perform without helps the necessary activities of daily life due to activity limitations in the usual environment. The consequence is a restriction of participation. In physical and Rehabilitation Medicine (PRM), dependency impacts the healthcare team activity at several levels: patient's referral and care plan, conditions of home return and resumption of course of life, burden of care assessment and care teams management...\n\nThe main goal of this project is the validation of a score assessing physical and cognitive activities of patients in follow-up care and rehabilitation (FRC) departments based on the ICF model (International Classification of Functioning, Disability and Health) : the SOFMER Activity Scale (SAS).\n\nWe want to propose a French generic scale allowing quantifying precisely the dependence and burden of care of patients in FRC departments. This scale needs to be valid, easy to apply, easy to learn, reproducible, sensitive to change and common to adult subjects, children and elderly."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients hospitalized in a FRC department', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women aged 2 years old\n* Hospitalized in the participating department for at least 4 days\n* For the responsiveness study : patients hospitalized in the FRC departments for obesity, spinal cord injuries, post-stroke rehabilitation or cardiorespiratory rehabilitation after cardiac surgery\n\nExclusion Criteria:\n\n* Non-recipient of French Social Security'}, 'identificationModule': {'nctId': 'NCT03116204', 'acronym': 'SAS', 'briefTitle': 'Validation of a SOFMER Activity Scale', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Validation of a Score Assessing Physical and Cognitive Activities of Patients in Follow-up Care and Rehabilitation Departments: the SOFMER Activity Score', 'orgStudyIdInfo': {'id': '69HCL17_0027'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients hospitalized in a FRC department', 'interventionNames': ['Other: Assessment of score SAS']}], 'interventions': [{'name': 'Assessment of score SAS', 'type': 'OTHER', 'description': 'Assessment of a score assessing physical and cognitive activities of patients in follow-up care and rehabilitation departments', 'armGroupLabels': ['Patients hospitalized in a FRC department']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Angers', 'country': 'France', 'facility': 'Centre SSR Les Capucins', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Berck', 'country': 'France', 'facility': 'Etablissement Hopale-Centre Calvé', 'geoPoint': {'lat': 50.4, 'lon': 1.6}}, {'city': 'Brest', 'country': 'France', 'facility': 'Service SSRS Enfants et Adolescents, Fondation Ildys', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'city': 'Échirolles', 'country': 'France', 'facility': 'Département de Rééducation Neurologique - Hôpital Sud - CHU de Grenoble', 'geoPoint': {'lat': 45.14603, 'lon': 5.71441}}, {'city': 'Garche', 'country': 'France', 'facility': 'Médecine physique et réadaptation - Hôpital Raymond Poincaré - APHP', 'geoPoint': {'lat': 49.39455, 'lon': 6.19775}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Ctre Médico-Chir Réadapt Des Massues', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Service de Médecine physique et Réadaptation - Hôpital Henry Gabrielle', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Paris', 'country': 'France', 'facility': 'Service de Médecine Physique et de Réadaptation - F.Widal - APHP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Saint-Etienne', 'country': 'France', 'facility': 'Service de Médecine Physique et Réadaptation - Pôle Couple Mère-Enfant - HOPITAL DE BELLEVUE', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'Carole VUILLEROT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}