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

Phase 1

Completed

• Conditions: Leprosy; Disability Evaluation; Quality of Life

• Registration Number: NCT01006759
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2007-01
• Primary Completion: 2008-12
• Study Completion: 2009-08
• Status Verified: 2009-11
• Study First Submitted: 2009-11-02
• Study First Submitted QC: 2009-11-02
• Last Update Submitted: 2009-11-02
• Study First Posted: 2009-11-03
• Last Update Posted: 2009-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
classification of disability for Leprosy(WHO)	1 year

Secondary Outcome Measures

Name	Time	Method
classification of disability for Leprosy(WHO), grip strength and threshold sensibility	after 1 year

Trial Locations

Locations (1)

School of Medicine, University of Sao Paulo; 🇧🇷 Ribeirao Preto, SP, Brazil