Clinical trial NCT01006759: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Leprosy
Disability Evaluation
Quality of Life
Keywords: Leprosy
Disability Evaluation
Quality of Life
Sensation
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2009-11-03
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: classification of disability for Leprosy(WHO)
timeFrame: 1 year
Secondary outcomes:
measure: classification of disability for Leprosy(WHO), grip strength and threshold sensibility
timeFrame: after 1 year
Other outcomes:
Locations:
city: Ribeirao Preto
country: Brazil
facility: School of Medicine, University of Sao Paulo
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Marisa CR Fonseca, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.