Prevention of Disability: Proposal for a Guidance Manual for Leprosy Patients - Full Text View

Sponsor:	University of Sao Paulo
Collaborator:	The National Council for Scientific and Technological Development (CNPq)
Information provided by:	University of Sao Paulo
ClinicalTrials.gov Identifier:	NCT01006759

Purpose

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	Intervention	Phase
Leprosy Disability Evaluation Quality of Life	Other: exercise and orientation	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Proposal Evaluation and Intervention Through Prevention of Disability in Leprosy Patients

Resource links provided by NLM:

MedlinePlus related topics: Foot Health Mycobacterial Infections

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:

classification of disability for Leprosy(WHO) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

classification of disability for Leprosy(WHO), grip strength and threshold sensibility [ Time Frame: after 1 year ] [ Designated as safety issue: Yes ]

Enrollment:	55
Study Start Date:	January 2007
Study Completion Date:	August 2009
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01006759

Locations

Brazil
School of Medicine, University of Sao Paulo
Ribeirao Preto, SP, Brazil, 14049900

Sponsors and Collaborators

University of Sao Paulo

The National Council for Scientific and Technological Development (CNPq)

Investigators

Principal Investigator:

Marisa CR Fonseca, PhD

University of Sao Paulo

More Information

Additional Information:

official website of the ministry of health This link exits the ClinicalTrials.gov site

Publications:

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.

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
Study First Received:	November 2, 2009
Last Updated:	November 2, 2009
Health Authority:	Brazil: Ministry of Health

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

ClinicalTrials.gov processed this record on February 09, 2012