Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-01-01 @ 8:21 PM
Study NCT ID:
NCT01006759
Status:
COMPLETED
Last Update Posted:
2009-11-03
First Post:
2009-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Disability: Proposal for a Guidance Manual for Leprosy Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007918', 'term': 'Leprosy'}], 'ancestors': [{'id': 'D009165', 'term': 'Mycobacterium Infections, Nontuberculous'}, {'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D003376', 'term': 'Counseling'}, {'id': 'D006293', 'term': 'Health Promotion'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D006266', 'term': 'Health Education'}, {'id': 'D011314', 'term': 'Preventive Health Services'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-11-02', 'studyFirstSubmitDate': '2009-11-02', 'studyFirstSubmitQcDate': '2009-11-02', 'lastUpdatePostDateStruct': {'date': '2009-11-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'classification of disability for Leprosy(WHO)', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'classification of disability for Leprosy(WHO), grip strength and threshold sensibility', 'timeFrame': 'after 1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Leprosy', 'Disability Evaluation', 'Quality of Life', 'Sensation'], 'conditions': ['Leprosy', 'Disability Evaluation', 'Quality of Life']}, 'referencesModule': {'references': [{'pmid': '19229402', 'type': 'BACKGROUND', 'citation': "Lana FC, Amaral EP, Lanza FM, Saldanha AN. Physical disabilities resulting from Hansen's disease in Vale do Jequitinhonha/state of Minas Gerais, Brazil. Rev Lat Am Enfermagem. 2008 Nov-Dec;16(6):993-7. doi: 10.1590/s0104-11692008000600009."}], 'seeAlsoLinks': [{'url': 'http://www.saude.gov.br', 'label': 'official website of the ministry of health'}]}, 'descriptionModule': {'briefSummary': 'Leprosy is an infectious disease of slow evolution, manifested primarily by signs and symptoms dermatoneurological with skin lesions and peripheral nerve, especially in the eyes, hands and feet. The prevention of disability is essential for the control of complications. Objective: To evaluate the physical and functional status of hands, feet and eyes, for the appearance and evolution of sensory and motor deficiencies and classification of disability (WHO) of a group of leprosy patients to compare and monitor the result treatment on the progression of neuropathy and recurrence of reactions. Methodology: We performed initial physical therapy evaluation and final, after 12 months. We conducted a clinical trial of a series of 26 cases evaluated with newly diagnosed leprosy, treated by standard medication. There were used methods of qualitative and quantitative. An illustrated manual of guidelines was especially developed for this study.', 'detailedDescription': 'assessment methods of qualitative and quantitative: inspection of eyes, hands and foot, manual motor function, grip and pinch dynamometry,threshold test, SF 36 quality of life questionnaire.\n\nIntervention: illustrated guidelines, exercises, orthoses, orientation Goals: disability prevention'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patients in this project were diagnosed and referred by the dermatology to do the physical-functional evaluation and physiotherapy. We selected patients aged 18 years and both sexes, even with comorbidities, since diagnosed and treated. In accepting to participate in the research, signed a consent form\n\nExclusion Criteria:\n\n* Those patients who refused to sign the consent form and those who did not attend the evaluations'}, 'identificationModule': {'nctId': 'NCT01006759', 'briefTitle': 'Prevention of Disability: Proposal for a Guidance Manual for Leprosy Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Proposal Evaluation and Intervention Through Prevention of Disability in Leprosy Patients', 'orgStudyIdInfo': {'id': 'FMRPUSP'}, 'secondaryIdInfos': [{'id': 'HCRP n°14553/2005'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'leprosy disability', 'description': 'intervention of a series of cases with leprosy that made treatment in a Clinical Hospital', 'interventionNames': ['Other: exercise and orientation']}], 'interventions': [{'name': 'exercise and orientation', 'type': 'OTHER', 'otherNames': ['prevention of disability', 'guidance', 'orientation', 'promotion of health'], 'description': 'guidances for prevention of disability in leprosy with focus on hands, eyes and feet.', 'armGroupLabels': ['leprosy disability']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14049900', 'city': 'Ribeirão Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'School of Medicine, University of Sao Paulo', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}], 'overallOfficials': [{'name': 'Marisa CR Fonseca, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Conselho Nacional de Desenvolvimento Científico e Tecnológico', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Marisa de Cássia Registro Fonseca', 'oldOrganization': 'School of Medicine, University of Sao Paulo'}}}}