Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT03482869
Status:
UNKNOWN
Last Update Posted:
2018-03-29
First Post:
2018-03-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Self-reported Walking Impairment in Predominantly Illiterate Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective cohort'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-03-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-28', 'studyFirstSubmitDate': '2018-03-14', 'studyFirstSubmitQcDate': '2018-03-28', 'lastUpdatePostDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximal walking distance', 'timeFrame': '10 minutes', 'description': 'Maximal measured distance will be the distance walked during a 6 min walk tests'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['walking impairment', 'disability', 'diabetes mellitus'], 'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the routine feasibility of an image tool adapted from the WELCH questionnaire ( Walking estimated limitation calculated by history) to estimate walking impairment (The WELSH questionnaire: Walking estimated limitation stated by history) in patients investigated for walking impairment. Secondary aims correlation with the maximal walking distance.', 'detailedDescription': 'The WELSH is self completed by the patients and scored by the physician after self-completion. Patients perform a 6 minutes walking test on a 30m corridor'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* •Signed consent for the data treatment as a database\n\nExclusion Criteria:\n\n* Rebuttal to participate'}, 'identificationModule': {'nctId': 'NCT03482869', 'acronym': 'WELSH', 'briefTitle': 'Evaluation of Self-reported Walking Impairment in Predominantly Illiterate Patients', 'organization': {'class': 'OTHER', 'fullName': 'Université Polytechnique de Bobo-Dioulasso'}, 'officialTitle': 'The Walking Estimated Limitation Stated by History (WELSH): A Visual Tool to Self-report Walking Impairment From a Predominantly Illiterate Diabetic Population.', 'orgStudyIdInfo': {'id': 'Bobo 2018-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diabetic patients', 'description': 'Patients referred for the equilibrium or diagnosis of diabetes mellitus will be proposed to participate and estimate their walking ability with the WELSH (Walking estimated limitation stated by History) based solely on images', 'interventionNames': ['Diagnostic Test: walking ability']}], 'interventions': [{'name': 'walking ability', 'type': 'DIAGNOSTIC_TEST', 'description': 'Included patients will perform a 6 min walk test', 'armGroupLabels': ['Diabetic patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bobo-Dioulasso', 'country': 'Burkina Faso', 'contacts': [{'name': 'Nafi OUEDRAOGO', 'role': 'CONTACT'}], 'facility': 'CHU Souro Sanou', 'geoPoint': {'lat': 11.18064, 'lon': -4.29489}}], 'centralContacts': [{'name': 'Nafi OUEDRAOGO, MD', 'role': 'CONTACT', 'email': 'Nafioued@yahoo.fr', 'phone': '+22670155806'}], 'overallOfficials': [{'name': 'Nafi OUEDRAOGO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Souro Sanou'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Probably available upon request. Undecided yet'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université Polytechnique de Bobo-Dioulasso', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of department of physiology', 'investigatorFullName': 'Nafi OUEDRAOGO', 'investigatorAffiliation': 'Université Polytechnique de Bobo-Dioulasso'}}}}