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CompletedNCT01006759Updated Nov 3, 2009

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

A Phase 1 interventional study of exercise and orientation in Leprosy, Disability Evaluation and Quality of Life, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-11-03.

Sponsored by University of Sao Paulo · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
55
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Leprosy
  • Disability Evaluation
  • Quality of Life

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Keywords

  • Leprosy
  • Disability Evaluation
  • Quality of Life
  • Sensation
03

In context

Leprosy

52 studies on the registry are indexed under Leprosy; 13 are open to participants now.

This study's enrollment of 55 is below the median of 70 across 41 interventional studies indexed under Leprosy.

Browse Leprosy studies →

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,035 studies on the registry; 95 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Those patients who refused to sign the consent form and those who did not attend the evaluations
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
55 participants (actual)

Study arms

  • Experimental
    leprosy disability

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

    Other: exercise and orientation

Interventions

  • Otherexercise and orientation

    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

06

What researchers measure

Primary outcomes

  1. classification of disability for Leprosy(WHO)

    Time frame: 1 year

Secondary outcomes

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

    Time frame: after 1 year

07

Study locations

1 site
  • School of Medicine, University of Sao Paulo
    Ribeirao Preto, SP 14049900, Brazil
08

References and documents

Publications

  • 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. PubMed 19229402 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2007, a primary completion of Dec 2008 and a completion of Aug 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 2, 2009
First posted
Nov 3, 2009
Start
Jan 2007
Primary completionActual
Dec 2008
CompletionActual
Aug 2009
Last update
Nov 3, 2009
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 3, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01006759
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted
Nov 3, 2009
Start date
Jan 2007
Primary completion
Dec 2008
Completion
Aug 2009
Last update
Nov 3, 2009

Study contacts

Marisa CR Fonseca, PhD
principal investigator · University of Sao Paulo

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2009. You cannot join it, but the record below documents what was studied.

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