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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01006759
Other study ID # FMRPUSP
Secondary ID HCRP n°14553/200
Status Completed
Phase Phase 1
First received November 2, 2009
Last updated November 2, 2009
Start date January 2007
Est. completion date August 2009

Study information

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

Clinical Trial Summary

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.


Description:

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.

Intervention: illustrated guidelines, exercises, orthoses, orientation Goals: disability prevention


Recruitment information / eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
exercise and orientation
guidances for prevention of disability in leprosy with focus on hands, eyes and feet.

Locations

Country Name City State
Brazil School of Medicine, University of Sao Paulo Ribeirao Preto SP

Sponsors (2)

Lead Sponsor Collaborator
University of Sao Paulo Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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

Outcome

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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