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

Quality of Life Clinical Trial

Official title:

Proposal Evaluation and Intervention Through Prevention of Disability in Leprosy Patients

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

• Disability Evaluation
• Leprosy
• Quality of Life

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

External Links

•   official website of the ministry of health