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

Primary Purpose

Leprosy, Disability Evaluation, Quality of Life

Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
exercise and orientation
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Leprosy focused on measuring Leprosy, Disability Evaluation, Quality of Life, Sensation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • School of Medicine, University of Sao Paulo

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

leprosy disability

Arm Description

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

Outcomes

Primary Outcome Measures

classification of disability for Leprosy(WHO)

Secondary Outcome Measures

classification of disability for Leprosy(WHO), grip strength and threshold sensibility

Full Information

First Posted
November 2, 2009
Last Updated
November 2, 2009
Sponsor
University of Sao Paulo
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT01006759
Brief Title
Prevention of Disability: Proposal for a Guidance Manual for Leprosy Patients
Official Title
Proposal Evaluation and Intervention Through Prevention of Disability in Leprosy Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Sao Paulo
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leprosy, Disability Evaluation, Quality of Life
Keywords
Leprosy, Disability Evaluation, Quality of Life, Sensation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
leprosy disability
Arm Type
Experimental
Arm Description
intervention of a series of cases with leprosy that made treatment in a Clinical Hospital
Intervention Type
Other
Intervention Name(s)
exercise and orientation
Other Intervention Name(s)
prevention of disability, guidance, orientation, promotion of health
Intervention Description
guidances for prevention of disability in leprosy with focus on hands, eyes and feet.
Primary Outcome Measure Information:
Title
classification of disability for Leprosy(WHO)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
classification of disability for Leprosy(WHO), grip strength and threshold sensibility
Time Frame
after 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marisa CR Fonseca, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Medicine, University of Sao Paulo
City
Ribeirao Preto
State/Province
SP
ZIP/Postal Code
14049900
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
19229402
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.
Results Reference
background
Links:
URL
http://www.saude.gov.br
Description
official website of the ministry of health

Learn more about this trial

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

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