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

This study has been completed.
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01006759
First received: November 2, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted

November 2, 2009
November 2, 2009
January 2007
December 2008   (final data collection date for primary outcome measure)
classification of disability for Leprosy(WHO) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
classification of disability for Leprosy(WHO), grip strength and threshold sensibility [ Time Frame: after 1 year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Prevention of Disability: Proposal for a Guidance Manual for Leprosy Patients
Proposal Evaluation and Intervention Through Prevention of Disability in Leprosy Patients

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.

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

Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Leprosy
  • Disability Evaluation
  • Quality of Life
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
Experimental: leprosy disability
intervention of a series of cases with leprosy that made treatment in a Clinical Hospital
Intervention: Other: exercise and orientation
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
August 2009
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01006759
FMRPUSP, HCRP n°14553/2005
Yes
Marisa de Cássia Registro Fonseca, School of Medicine, University of Sao Paulo
University of Sao Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Principal Investigator: Marisa CR Fonseca, PhD University of Sao Paulo
University of Sao Paulo
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP