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

NCT01006759 | Completed Phase 1 DMC

• 2 other identifiers: FMRPUSPHCRP n°14553/2005
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Leprosy; Disability Evaluation; Quality of Life

Keywords

Leprosy; Disability Evaluation; Quality of Life; Sensation

Outcome Measures

Primary Outcomes (1)

• classification of disability for Leprosy(WHO)

  1 year

Secondary Outcomes (1)

• classification of disability for Leprosy(WHO), grip strength and threshold sensibility

  after 1 year

Study Arms (1)

leprosy disability

EXPERIMENTAL

intervention of a series of cases with leprosy that made treatment in a Clinical Hospital

Other: exercise and orientation

Interventions

exercise and orientation OTHER

guidances for prevention of disability in leprosy with focus on hands, eyes and feet.

Also known as: prevention of disability, guidance, orientation, promotion of health

leprosy disability

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Those patients who refused to sign the consent form and those who did not attend the evaluations

Sponsors & Collaborators

• University of Sao Paulo: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

School of Medicine, University of Sao Paulo

Ribeirão Preto, São Paulo, 14049900, Brazil

Location

Related 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. doi: 10.1590/s0104-11692008000600009.

  PMID: 19229402 BACKGROUND

Related Links

• official website of the ministry of health

MeSH Terms

Conditions

Leprosy

Interventions

Exercise; Counseling; Health Promotion

Condition Hierarchy (Ancestors)

Mycobacterium Infections, Nontuberculous; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Health Education; Preventive Health Services

Study Officials

• Marisa CR Fonseca, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 2, 2009
• First Posted: November 3, 2009
• Study Start: January 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: August 1, 2009
• Last Updated: November 3, 2009

Record last verified: 2009-11

Locations

BR (1)