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Main
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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. |
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Register:
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REBEC |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
RBR-8q4zfh |
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Date of registration:
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13/02/2012 |
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Primary sponsor: |
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Public title:
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Relationship between the muscles thigh characteristics and sensory and motor changes for subjects with early degrees of knee osteoarthritis
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Scientific title:
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Correlation between vastus lateralis morphology and neuromuscular control for patients with knee osteoarthritis grade I and II
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Date of first enrolment:
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01/01/2010 |
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Target sample size:
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30 |
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Recruitment status: |
recruitment completed |
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URL:
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http://www.ensaiosclinicos.gov.br/rg/RBR-8q4zfh/ |
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Study type:
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Study design:
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Cross-sectional and observational study, case-control, prognosis
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Paula
Serrão |
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Address:
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Rua Carlos Simplício Rodrigues nbo. 75 apto 24. Jd Gibertoni
13574-580
São Carlos
Brazil |
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Telephone:
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(16) 33715587 |
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Email:
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ppregina@yahoo.com.br |
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Affiliation:
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Universidade Federal de São Carlos |
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Name:
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Paula
Serrão |
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Address:
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Rua Carlos Simplício Rodrigues nbo. 75 apto 24. Jd Gibertoni
13574-580
São Carlos
Brazil |
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Telephone:
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(16) 33715587 |
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Email:
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ppregina@yahoo.com.br |
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Affiliation:
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Universidade Federal de São Carlos |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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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
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M00-M99
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Intervention(s)
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cross sectional study, without intervention
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Primary Outcome(s)
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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
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Secondary Outcome(s)
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Through the results of the primary outcomes will be provided a scientific basis to contribute to the clinical practice, directing rehabilitation programs
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Secondary ID(s)
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0031.0.135.000-07
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143/2007
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Source(s) of Monetary Support
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Fundação de Amparo à Pesquisa do Estado de São Paulo - Brazil
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