Quality of Life Clinical Trial
Official title:
Proposal Evaluation and Intervention Through Prevention of Disability in Leprosy Patients
Verified date | November 2009 |
Source | University of Sao Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 55 |
Est. completion date | August 2009 |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - Those patients who refused to sign the consent form and those who did not attend the evaluations |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Brazil | School of Medicine, University of Sao Paulo | Ribeirao Preto | SP |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo | Conselho Nacional de Desenvolvimento Científico e Tecnológico |
Brazil,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | classification of disability for Leprosy(WHO) | 1 year | Yes | |
Secondary | classification of disability for Leprosy(WHO), grip strength and threshold sensibility | after 1 year | Yes |
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