Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2026-02-19 @ 12:05 PM
Study NCT ID:
NCT02297295
Status:
UNKNOWN
Last Update Posted:
2015-11-17
First Post:
2014-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Exercise Medicine on Lower Limb Amputees According to the International Classification of Functioning
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-11-16', 'studyFirstSubmitDate': '2014-07-10', 'studyFirstSubmitQcDate': '2014-11-20', 'lastUpdatePostDateStruct': {'date': '2015-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in 6 minutes walk test', 'timeFrame': 'at -1, 0, 2 and 4 mounths'}], 'secondaryOutcomes': [{'measure': 'Change in Timed Up and Go', 'timeFrame': 'at -1, 0, 2 and 4 mounths'}, {'measure': 'Change in Satisfaction towards prothesis questionnaire (SAT-PRO)', 'timeFrame': 'at -1, 0, 2 and 4 mounths', 'description': 'questionnaire'}, {'measure': 'Change in Flexibility test', 'timeFrame': 'at -1, 0, 2 and 4 mounths', 'description': 'measurement of distance between fingers and floor'}, {'measure': 'Change in Isokinetic strength testing', 'timeFrame': 'at -1, 0, 2 and 4 mounths'}, {'measure': 'Change in Prosthetic Profile of the Amputee', 'timeFrame': 'at -1, 0, 2 and 4 mounths'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sequelae of; Amputation, Traumatic, Limb, Lower'], 'conditions': ['Lower Limb Amputees']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether exercise medicine in lower limb amputees has a impact on the three domains of the International Classification of Functioning of the WHO (function, activities and participation), and on quality of life.', 'detailedDescription': 'Exercise medicine in lower limb amputees has a positive impact on physical condition and on some cardiovascular aspects (first domain of ICF). But as the investigators know, there is no evidence that this improvement is connected with a significant benefit on the performance of daily live activities and social participation (second and third domains of the ICF).\n\nThe investigators want to determine benefits of exercise medicine on all of these domains.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* unilateral lower limb amputation\n* amputees with prothesis\n* after learning how to walk with the prothesis\n* walking with or without technical aids\n\nExclusion Criteria:\n\n* previous exercise training'}, 'identificationModule': {'nctId': 'NCT02297295', 'briefTitle': 'Impact of Exercise Medicine on Lower Limb Amputees According to the International Classification of Functioning', 'organization': {'class': 'OTHER', 'fullName': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}, 'officialTitle': 'Impact of Exercise Medicine on Lower Limb Amputees According to the Three Domains of the International Classification of Functioning', 'orgStudyIdInfo': {'id': 'EMA001'}, 'secondaryIdInfos': [{'id': '2014/09AVR/175', 'type': 'OTHER', 'domain': 'StLuc'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Physiotherapy', 'description': 'Comparing the patients to themselves (spontaneus evolution) before intervention.', 'interventionNames': ['Other: Physiotherapy']}], 'interventions': [{'name': 'Physiotherapy', 'type': 'OTHER', 'description': 'Physiotherapy three times a week for 8 weeks according to a well-defined protocol', 'armGroupLabels': ['Physiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'facility': 'Service de médecine physique et réadapation des Cliniques Universitaires Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'centralContacts': [{'name': 'Gilles Caty', 'role': 'CONTACT', 'email': 'gilles.caty@uclouvain.be', 'phone': '003227641650'}], 'overallOfficials': [{'name': 'Gilles Caty', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}