Prevention of Disability: Proposal for a Guidance Manual for Leprosy Patients

NCT ID: NCT01006759

Last Updated: 2009-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2009-08-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Leprosy Disability Evaluation Quality of Life

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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leprosy disability

intervention of a series of cases with leprosy that made treatment in a Clinical Hospital

Group Type EXPERIMENTAL

exercise and orientation

Intervention Type OTHER

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

Interventions

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exercise and orientation

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

Intervention Type OTHER

Other Intervention Names

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prevention of disability guidance orientation promotion of health

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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School of Medicine, University of Sao Paulo

Principal Investigators

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Marisa CR Fonseca, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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School of Medicine, University of Sao Paulo

Ribeirão Preto, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 19229402 (View on PubMed)

Related Links

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http://www.saude.gov.br

official website of the ministry of health

Other Identifiers

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HCRP n°14553/2005

Identifier Type: -

Identifier Source: secondary_id

FMRPUSP

Identifier Type: -

Identifier Source: org_study_id

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