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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-8q4zfh
Date of registration: 13/02/2012
Primary sponsor: Paula Regina Mendes da Silva Serrão - Brazil
Public title: Relationship between the muscles thigh characteristics and sensory and motor changes for subjects with early degrees of knee osteoarthritis
Scientific title: Correlation between vastus lateralis morphology and neuromuscular control for patients with knee osteoarthritis grade I and II
Date of first enrolment: 01/01/2010
Target sample size: 30
Recruitment status: recruitment completed
URL:  http://www.ensaiosclinicos.gov.br/rg/RBR-8q4zfh/
Study type: 
Study design:  Cross-sectional and observational study, case-control, prognosis  
Countries of recruitment
Brazil
Contacts
Name: Paula  Serrão
Address:  Rua Carlos Simplício Rodrigues nbo. 75 apto 24. Jd Gibertoni 13574-580 São Carlos Brazil
Telephone: (16) 33715587
Email: ppregina@yahoo.com.br
Affiliation:  Universidade Federal de São Carlos
Name: Paula  Serrão
Address:  Rua Carlos Simplício Rodrigues nbo. 75 apto 24. Jd Gibertoni 13574-580 São Carlos Brazil
Telephone: (16) 33715587
Email: ppregina@yahoo.com.br
Affiliation:  Universidade Federal de São Carlos
Key inclusion & exclusion criteria
Inclusion criteria: The following inclusion criteria were used: male, sedentary, aged between 40 and 65 years. All the subjects underwent a radiological examination of both knees to confirm that they displayed signs of osteoarthritis (OA) (for osteoarthritis group) or not (for control group), such as the presence of osteophytes in at least one of the compartments of a knee joint (tibiofemoral or patellofemoral). In OA group the severity of OA was graded by a radiologist according the Kellgren & Lawrence system. We included in the OAG only those subjects with Grade I or II OA of the knee. In the control group the subjects should not present history of pain, trauma, surgery or fractures of the lower limbs.
Exclusion criteria: The exclusion criteria were: physical therapy (previous 12 months); knee or hip surgery; history of lower limb trauma; corticosteroid infiltration of the knee (previous 6 months); medical condition.

Age minimum: 40Y
Age maximum: 65Y
Gender: M
Health Condition(s) or Problem(s) studied
Knee osteoarthritis,study of the muscle morphology, prevention of neuromuscular disorders in humans with early degrees of knee osteoarthritis, assessment of quality of life, compared with healthy humans.
C05.550.114.606.500
M00-M99
Intervention(s)
cross sectional study, without intervention
Primary Outcome(s)
To detect that subjects with knee osteoarthritis show morphological muscle and neuromuscular changes that may already be present in early degrees of knee osteoarthritis. To evaluate the outcomes data will be compared torque and acceleration time (obtained during isokinetic evaluation) between healthy subjects and subjects with knee osteoarthritis. It will also analyze the proportion and type of muscle fibers through the morphological analysis of the muscular fragments, which also compared healthy subjects with subjects with knee osteoarthritis
Secondary Outcome(s)
Through the results of the primary outcomes will be provided a scientific basis to contribute to the clinical practice, directing rehabilitation programs
Secondary ID(s)
0031.0.135.000-07
143/2007
Source(s) of Monetary Support
Fundação de Amparo à Pesquisa do Estado de São Paulo - Brazil
Secondary Sponsor(s)
Universidade Federal de São Carlos - Brazil
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