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

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ClinicalTrials.gov Identifier: NCT01006759
Recruitment Status : Completed
First Posted : November 3, 2009
Last Update Posted : November 3, 2009
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by:
University of Sao Paulo

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.

Condition or disease Intervention/treatment Phase
Leprosy Disability Evaluation Quality of Life Other: exercise and orientation Phase 1

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


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Proposal Evaluation and Intervention Through Prevention of Disability in Leprosy Patients
Study Start Date : January 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: leprosy disability
intervention of a series of cases with leprosy that made treatment in a Clinical Hospital
Other: exercise and orientation
guidances for prevention of disability in leprosy with focus on hands, eyes and feet.
Other Names:
  • prevention of disability
  • guidance
  • orientation
  • promotion of health



Primary Outcome Measures :
  1. classification of disability for Leprosy(WHO) [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. classification of disability for Leprosy(WHO), grip strength and threshold sensibility [ Time Frame: after 1 year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01006759


Locations
Brazil
School of Medicine, University of Sao Paulo
Ribeirao Preto, SP, Brazil, 14049900
Sponsors and Collaborators
University of Sao Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Principal Investigator: Marisa CR Fonseca, PhD University of Sao Paulo

Additional Information:
Publications:
Responsible Party: Marisa de Cássia Registro Fonseca, School of Medicine, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01006759     History of Changes
Other Study ID Numbers: FMRPUSP
HCRP n°14553/2005
First Posted: November 3, 2009    Key Record Dates
Last Update Posted: November 3, 2009
Last Verified: November 2009

Keywords provided by University of Sao Paulo:
Leprosy
Disability Evaluation
Quality of Life
Sensation

Additional relevant MeSH terms:
Leprosy
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections