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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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27 May 2013 |
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Main ID: |
RBR-8zdzkk |
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Date of registration:
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31/01/2012 |
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Primary sponsor: |
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Public title:
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Performance evaluation of individuals after stroke and its correlation with the ability to throw weight to the affected side
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Scientific title:
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Analysis of functional performance and its correlation with the weight transfer in hemiparetic individuals |
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Date of first enrolment:
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10/05/2010 |
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Target sample size:
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40 |
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Recruitment status: |
data analysis completed |
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URL:
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http://www.ensaiosclinicos.gov.br/rg/RBR-8zdzkk/ |
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Study type:
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Observational |
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Study design:
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Cross-sectional study, single-group.
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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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Gustavo
Luvizutto |
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Address:
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Avenida da Saudade - 225
18650000
São Manuel
Brazil |
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Telephone:
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14-38411284 |
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Email:
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gluvizutto@fmb.unesp.br |
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Affiliation:
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Gustavo José Luvizutto |
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Name:
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Gustavo
Luvizutto |
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Address:
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Avenida da Saudade - 225
18650000
São Manuel
Brazil |
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Telephone:
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14-38411284 |
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Email:
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gluvizutto@fmb.unesp.br |
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Affiliation:
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Gustavo José Luvizutto |
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Key inclusion & exclusion criteria
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Inclusion criteria: We included individuals who had independent gait;
Ischemic or hemorrhagic stroke in any territory evidenced by computed tomography (CT);
Age above 30 and below 65 years;
Have hemiplegia or hemiparesis resulting from single and unilateral stroke.
Exclusion criteria: Cognitive impairment;
Neurological deficit in addition to hemiparesis from stroke;
Osteoarticular complications (fractures, deformities or ankylosis structured;
Time of injury in excess of twelve months.
Age minimum:
18Y
Age maximum:
65Y
Gender:
-
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Health Condition(s) or Problem(s) studied
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Stroke C10.228.140.300.775
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Intervention(s)
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0 hemiparetic patients will be evaluated within the period of 6 months by evaluating the dynamic range of spasticity, symmetry and protocol transfer weight (minimum and maximum capacity of symmetry and transfers), level of disability and functional performance. The dynamic range of spasticity assess the difference between slow and fast stretch of the biceps and retofemoral measured by goniometer. The assessment by observation of symmetry and weight transfer record for each item found, the score ranging from 1 to 3 points in the sitting position, and 1 to 4 points in the standing position, as to the minimum and maximum capacity of symmetry and shipments. When items are added indicate a minimum score of 8 and maximum of 27 points in a growing share would indicate conditions classified as symmetrically by author: lack of symmetry and weight transfer (8 points), minimal symmetry and weight transfer (10 to 13 points), moderate capacity for symmetry and transfer of weight (14 to 18 points), the capacity of symmetry and partially good transfer of weight (19 to 24 points), the capacity of symmetry and good transfer of weight (25 to 26 points) and of full symmetry and weight transfer (27 points). The level of disability will be assessed through disability modified Rankin Scale (0-Asymptomatic; 1-symptoms without disability, able to perform their usual tasks and activities in advance; 2 - mild disability, unable to perform all their usual activities beforehand, but able to carry your personal needs without assistance; 3-Moderate disability, requiring some help for their activities, but able to walk without help from another person, 4-moderate to severe disability, inability to walk unaided, inability to perform their activities without help, 5-severe disability, limited to bed, incontinence care nurses and requires constant attention; 6-Death. Functional performance is assessed by Barthel Index, composed of 10 items (feeding, bathing, personal care , ability to dress, intesti
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Primary Outcome(s)
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Expected to find negative correlation between the index of performance (low functional performance the closer to 0 and high performance functional as closer to 100) and level of disability of individuals (0-no symptoms, 1-symptoms without disability, 2-mild disability, 3-moderate disability, 4-moderate to severe disability, 5-severe disability and 6-death)and a positive correlation between the index of performance (low functional performance the closer to 0 and the more high-performance functional near 100) and the analysis of symmetry and weight transfer procotolo evaluated by analysis of symmetry and weight transfer (8-symmetry and lack of weight transfer, 10 to 13- minimum capacity, 14 and 18- moderate capacity; 19 to 24- capacity partially good, 25 to 26 -well capacity, 27 - capacity full of symmetry and weight transfer).
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Secondary Outcome(s)
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Expected to find negative correlation between the degree of disability assessed by the Rankin disability scale modified (0-no symptoms, 1-symptoms without disability, 2-mild disability, 3-moderate disability, 4-moderate to severe disability, 5-severe disability and 6-death) and the degree of spasticity measured by the Tardieu scale (measured in degrees by goniometry of the difference between slow and fast stretch of the biceps and retofemoral). Individuals who present lower angle of spasticity should have better functional performance measured by the Barthel scale.
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Secondary ID(s)
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3495-2010
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Source(s) of Monetary Support
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Hospital das Clínicas da Faculdade de Medicina de Botucatu - Botucatu, SP, Brazil
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