Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT01647802
Status:
COMPLETED
Last Update Posted:
2015-03-26
First Post:
2012-07-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cross-over Study of Three Modular Devices for Aid in Patient Standing and Transfer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051346', 'term': 'Mobility Limitation'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-25', 'studyFirstSubmitDate': '2012-07-17', 'studyFirstSubmitQcDate': '2012-07-23', 'lastUpdatePostDateStruct': {'date': '2015-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of forward flexion of the spine (position of maximum horizontal displacement of C7)', 'timeFrame': 'Baseline (Day 0; cross-sectional study)', 'description': 'cm'}], 'secondaryOutcomes': [{'measure': 'Level of standing (maximum vertical displacement C7)', 'timeFrame': 'Baseline (Day 0; transversal study)', 'description': 'cm'}, {'measure': 'Angle of hip flexion (angle formed by the line connecting the acromion and the greater trochanter with the line connecting the greater trochanter and the lateral femoral condyle)', 'timeFrame': 'Baseline (Day 0; transversal study)', 'description': 'degrees'}, {'measure': 'Standing time (time from start of forward flexion and the beginning of the vertical stabilization phase)', 'timeFrame': 'Baseline (Day 0; transversal study)', 'description': 'seconds'}, {'measure': 'Verticalization achieved (yes/no)', 'timeFrame': 'Baseline (Day 0; transversal study)', 'description': 'yes/no'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['standing devices', 'transfer devices'], 'conditions': ['Mobility Limitation']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to evaluate via a physiological analysis of the movements involved in standing, the level of forward flexion of the spine (in cm on the horizontal axis) obtained with the apparatus "Tina" and to compare levels obtained in the same patients with stander/transfer devices "Turner" and "Vertic\'Easy".', 'detailedDescription': 'Secondary objectives of this study are to compare the three devices in terms of:\n\n* the level recovery of the spine on the vertical axis (vertical displacement C7, cm)\n* standing time, defined by the time between the start of the forward flexion and the beginning of the vertical stabilization phase (seconds)\n* the success rate of the verticalization of the patient (the attempt is considered successful when the vertical position is held for 10 seconds).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient must have given his/her informed and signed consent\n* The patient must be insured or beneficiary of a health insurance plan\n* The patient is in stable medical condition (no complications in the last 10 days)\n* The patient is unable to stand up by his/her self and requires help during transfers\n* The patient has muscular force (quadriceps) \\> 3 out of 5.\n\nExclusion Criteria:\n\n* The patient is participating in another study\n* The patient is in an exclusion period determined by a previous study\n* The patient is under judicial protection, under tutorship or curatorship\n* The patient refuses to sign the consent\n* It is impossible to correctly inform the patient\n* The patient is pregnant, parturient, or breastfeeding\n* The patient has a limited support from at least one lower limb\n* The patient has an unstable fracture\n* The patient has a fragile heart\n* The patient has joint pain localized in the knee, hip or ankle.\n* The patient has already used one of three mechanisms to help with standing and transfer used in this study\n* Behavioral problems (opposition, agitation)'}, 'identificationModule': {'nctId': 'NCT01647802', 'acronym': 'VTT', 'briefTitle': 'Cross-over Study of Three Modular Devices for Aid in Patient Standing and Transfer', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Cross-over Study of Three Modular Devices for Aid in Patient Standing and Transfer', 'orgStudyIdInfo': {'id': 'LOCAL/2012/EV-03'}, 'secondaryIdInfos': [{'id': '2012-A00638-35', 'type': 'OTHER', 'domain': 'RCB number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': "Turner-Vertic'Easy-Tina", 'description': "Standing will be attempted with the three devices in the following order: (1) Turner; (2) Vertic'Easy; (3) Tina.", 'interventionNames': ['Device: Standing attempts with the "Vertic\'Easy" Device', 'Device: Standing attempts with the "Turner" Device', 'Device: Standing attempts with the "Tina" device']}, {'type': 'EXPERIMENTAL', 'label': "Turner-Tina-Vertic'Easy", 'description': "Standing will be attempted with the three devices in the following order: (1) Turner; (2) Tina; (3) Vertic'Easy.", 'interventionNames': ['Device: Standing attempts with the "Vertic\'Easy" Device', 'Device: Standing attempts with the "Turner" Device', 'Device: Standing attempts with the "Tina" device']}, {'type': 'EXPERIMENTAL', 'label': "Vertic'Easy-Turner-Tina", 'description': "Standing will be attempted with the three devices in the following order: (1) Vertic'Easy; (2) Turner; (3) Tina.", 'interventionNames': ['Device: Standing attempts with the "Vertic\'Easy" Device', 'Device: Standing attempts with the "Turner" Device', 'Device: Standing attempts with the "Tina" device']}, {'type': 'EXPERIMENTAL', 'label': "Vertic'Easy-Tina-Turner", 'description': "Standing will be attempted with the three devices in the following order: (1) Vertic'Easy; (2) Tina; (3) Turner.", 'interventionNames': ['Device: Standing attempts with the "Vertic\'Easy" Device', 'Device: Standing attempts with the "Turner" Device', 'Device: Standing attempts with the "Tina" device']}, {'type': 'EXPERIMENTAL', 'label': "Tina-Turner-Vertic'Easy", 'description': "Standing will be attempted with the three devices in the following order: (1) Tina; (2) Turner; (3) Vertic'Easy.", 'interventionNames': ['Device: Standing attempts with the "Vertic\'Easy" Device', 'Device: Standing attempts with the "Turner" Device', 'Device: Standing attempts with the "Tina" device']}, {'type': 'EXPERIMENTAL', 'label': "Tina-Vertic'Easy-Turner", 'description': "Standing will be attempted with the three devices in the following order: (1) Tina; (2) Vertic'Easy; (3) Turner.", 'interventionNames': ['Device: Standing attempts with the "Vertic\'Easy" Device', 'Device: Standing attempts with the "Turner" Device', 'Device: Standing attempts with the "Tina" device']}], 'interventions': [{'name': 'Standing attempts with the "Vertic\'Easy" Device', 'type': 'DEVICE', 'otherNames': ["Vertic'Easy", 'Manufacturer : HMS-VILGO, Parc Eurasanté - 243, Rue Salvador Allendé 59120 LOOS LEZ LILLE,'], 'description': 'Included patients had never used any of the three devices evaluated in this study. Therefore the patient will make two attempts at standing on each device to enable him/her to get used to the device at the first attempt. A video recording will be made from a camera positioned laterally. Only the results of the second attempt will be a kinematic analysis and will be used for analyzes.', 'armGroupLabels': ["Tina-Turner-Vertic'Easy", "Tina-Vertic'Easy-Turner", "Turner-Tina-Vertic'Easy", "Turner-Vertic'Easy-Tina", "Vertic'Easy-Tina-Turner", "Vertic'Easy-Turner-Tina"]}, {'name': 'Standing attempts with the "Turner" Device', 'type': 'DEVICE', 'otherNames': ['Turner', 'Manufacturer : ETAC AB, Suède ; distributed in France by : FRANCE REHAB, ZA du Serroir, 54690 LAY SAINT CHRISTOPHE'], 'description': 'Included patients had never used any of the three devices evaluated in this study. Therefore the patient will make two attempts at standing on each device to enable him/her to get used to the device at the first attempt. A video recording will be made from a camera positioned laterally. Only the results of the second attempt will be a kinematic analysis and will be used for analyzes', 'armGroupLabels': ["Tina-Turner-Vertic'Easy", "Tina-Vertic'Easy-Turner", "Turner-Tina-Vertic'Easy", "Turner-Vertic'Easy-Tina", "Vertic'Easy-Tina-Turner", "Vertic'Easy-Turner-Tina"]}, {'name': 'Standing attempts with the "Tina" device', 'type': 'DEVICE', 'otherNames': ['Tina', 'Manufacturer : ALTER ECO Santé, 9 Boulevard de Maurens, 31270 CUGNAUX'], 'description': 'Included patients had never used any of the three devices evaluated in this study. Therefore the patient will make two attempts at standing on each device to enable him/her to get used to the device at the first attempt. A video recording will be made from a camera positioned laterally. Only the results of the second attempt will be a kinematic analysis and will be used for analyzes', 'armGroupLabels': ["Tina-Turner-Vertic'Easy", "Tina-Vertic'Easy-Turner", "Turner-Tina-Vertic'Easy", "Turner-Vertic'Easy-Tina", "Vertic'Easy-Tina-Turner", "Vertic'Easy-Turner-Tina"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU de Nîmes - Hôpital Universitaire Carémeau', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}], 'overallOfficials': [{'name': 'Emilie Viollet, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nîmes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}