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Trial registered on ANZCTR


Registration number
ACTRN12610000869077
Ethics application status
Approved
Date submitted
12/10/2010
Date registered
18/10/2010
Date last updated
18/10/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison among the use of exercises for the feet and inner soles in leprosy
Scientific title
The effect of feet exercises with and without inner soles on feet biomechanics in patients with leprosy
Secondary ID [1] 252796 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
leprosy 258298 0
Condition category
Condition code
Physical Medicine / Rehabilitation 258491 258491 0 0
Physiotherapy
Infection 258561 258561 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For treatment group 1 underwent 20 sessions over 30 minutes twice a week of exercises for stretching the calf to ankle mobility and to strengthening the intrinsic muscles of the feet. The patients were instructed to perform the same exercises at home once a day. For treatment group 2 was insoles adapted to each type of foot which were used by patients during four months. However, prior to making these insoles patients were evaluated using the criteria of the Ministry of Health. To fabricate the insole was used ethyl vinyl acetate (EVA) material, performing before a mold of the foot of each patient, and then added the metatarsal supports, or support for the plantar arch or heel according to the individual needs of each patient. The insoles were sanded until there is no protrusion that could injure the patient and were completely homogeneous. The volunteer was told to use the insole in the shoe favorite, removing the existing insole in it, using it for as long as possible during the day. For treatment group 3 were used 20 sessions of exercises as the group 1 and insoles adapted as the group 2 which were used by the volunteers during 4 months
Intervention code [1] 257319 0
Treatment: Other
Intervention code [2] 257392 0
Rehabilitation
Comparator / control treatment
The aim of this study was to compare the effects of traditional treatment is the use of exercises associated with the insole, with another group that used only insole and finally a third group that performed only exercises
Control group
Active

Outcomes
Primary outcome [1] 259327 0
to compare the biomechanicall foot in patients with Hansen's disease using photogrammetry to assess the forefoot, rearfoot, and plantar arch
Timepoint [1] 259327 0
After 20 exercise sessions or four months using the inner soles
Secondary outcome [1] 265775 0
Compare the use of exercise, the inner soles and the association of two features treatament using photogrammetry to assess the forefoot, rearfoot, and plantar arch
Timepoint [1] 265775 0
After 20 exercise sessions or four months using the inner soles

Eligibility
Key inclusion criteria
leprosy patients monitored by the municipal health service in need of treatment for the feet, with or without sensory deficit
Minimum age
41 Years
Maximum age
72 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
presence of motor disorders, amputees, diabetics, alcoholics, people with Acquired Immune Deficiency Syndrome or syphilis.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 2943 0
Brazil
State/province [1] 2943 0
Minas Gerais

Funding & Sponsors
Funding source category [1] 257765 0
University
Name [1] 257765 0
Universidade Jose do Rosario Vellano - UNIFENAS
Address [1] 257765 0
Rod. MG 179, Km 0
Alfenas - Minas Gerais
37130-000
Country [1] 257765 0
Brazil
Primary sponsor type
University
Name
Universidade Jose do Rosario Vellano
Address
Rod. MG 179, Km 0
Alfenas - Minas Gerais
37130-000
Country
Brazil
Secondary sponsor category [1] 256977 0
None
Name [1] 256977 0
Address [1] 256977 0
Country [1] 256977 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259807 0
Ethics and Research Committee of UNIFENAS
Ethics committee address [1] 259807 0
Universidade Jose do Rosario Vellano
Rod. MG 179, Km 0
Alfenas - Minas Gerais
37130-000
Ethics committee country [1] 259807 0
Brazil
Date submitted for ethics approval [1] 259807 0
Approval date [1] 259807 0
07/06/2006
Ethics approval number [1] 259807 0
Parecer 36/2006

Summary
Brief summary
The purpose of this work was to compare the biomechanical foot in patients with Hansen's disease that accomplish exercises for the intrinsic muscles of the foot with leprosy patient that only use their inner soles and leprosy patient that use the inner soles and accomplish exercises for intrinsic musculature of the foot.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31719 0
Address 31719 0
Country 31719 0
Phone 31719 0
Fax 31719 0
Email 31719 0
Contact person for public queries
Name 14966 0
Denise Hollanda Iunes
Address 14966 0
Professor Carvalho Junior, 53/901 Street
Downtown
Alfenas - Minas Gerais
37130-000
Country 14966 0
Brazil
Phone 14966 0
55 35 32991380 (for Alfenas)
Fax 14966 0
55 35 32991381 (for Alfenas)
Email 14966 0
deniseiunes@unifal-mg.edu.br
Contact person for scientific queries
Name 5894 0
Denise Hollanda Iunes
Address 5894 0
Professor carvalho Junior, 53/901 Street
Downtown
Alfenas - Minas Gerais
37130-000
Country 5894 0
Brazil
Phone 5894 0
55 35 32991380 (for Alfenas)
Fax 5894 0
55 35 32991381 (for Alfenas)
Email 5894 0
deniseiunes@unifal-mg.edu.br

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary