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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: REBEC
Last refreshed on: 29 April 2013
Main ID:  RBR-6j2vvr
Date of registration: 15/06/2012
Primary sponsor: Universidade Federal de Juiz de Fora - Juiz de Fora, MG, Brazil
Public title: Assessment of static balance in lower limb amputees
Scientific title: Static stability evaluation in subjects with unilateral transtibial amputation traumatic.
Date of first enrolment: 10/01/2011
Target sample size: 20
Recruitment status: data analysis completed
URL:  http://www.ensaiosclinicos.gov.br/rg/RBR-6j2vvr/
Study type: 
Study design:  Observational and transversal study  
Countries of recruitment
Brazil
Contacts
Name: Marcelle  Ribeiro
Address:  Rua Carangola, 328-Democrata 36035220 Juiz de Fora Brazil
Telephone: (32)88072601
Email: marcelleribeirofst@yahoo.com.br
Affiliation:  Universidade Federal de Juiz de Fora
Name: Marcelle  Ribeiro
Address:  Rua Carangola, 328-Democrata 36035220 Juiz de Fora Brazil
Telephone: (32)88072601
Email: marcelleribeirofst@yahoo.com.br
Affiliation:  Universidade Federal de Juiz de Fora
Key inclusion & exclusion criteria
Inclusion criteria: Amputees prostheses for more than one year and not amputated;
Ability to walk without assistive devices for walking;
Use prosthesis aligned with dynamic Sach ® foot.

Exclusion criteria: Hypertension, cardiovascular disease, or any condition that alters the quality of gait.

Age minimum: 18Y
Age maximum: 60Y
Gender: M
Health Condition(s) or Problem(s) studied
Individuals with traumatic amputation, changes in static stability.
M01.150.100
G11.427.690
Intervention(s)
The study included 10 patients with transtibial amputation and 10 without amputação.All volunteers, both of the amputee as the group of non amputee were evaluated similarly. The volunteers were submitted to measurement of static stability through baropodometry, noninvasive method for maintaining the standing position for 30 seconds, which analyzed the oscillations of the body center of pressure.
Primary Outcome(s)
Decreased static stability in individuals with amputation and correlation with increasing age and shorter fitting, evaluated through analysis of the oscillation center of pressure by keeping the body upright posture for 30 seconds.
Secondary Outcome(s)
Increased sway area of the body center of pressure in individuals with transtibial amputation with advancing age and shorter fitting compared to the fitting area oscillation of body center of pressure of individuals without amputation.
Secondary ID(s)
0109.0.420.000-11
Source(s) of Monetary Support
Fundação de Amparo à Pesquisa de Minas Gerais - Belo Horizonte, MG, Brazil
Secondary Sponsor(s)
Universidade Federal de Juiz de Fora - Juiz de Fora, MG, Brazil
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