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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: 27 May 2013
Main ID:  RBR-8zdzkk
Date of registration: 31/01/2012
Primary sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho - Botucatu, SP, Brazil
Public title: Performance evaluation of individuals after stroke and its correlation with the ability to throw weight to the affected side
Scientific title: Analysis of functional performance and its correlation with the weight transfer in hemiparetic individuals
Date of first enrolment: 10/05/2010
Target sample size: 40
Recruitment status: data analysis completed
URL:  http://www.ensaiosclinicos.gov.br/rg/RBR-8zdzkk/
Study type:  Observational
Study design:  Cross-sectional study, single-group.  
Countries of recruitment
Brazil
Contacts
Name: Gustavo  Luvizutto
Address:  Avenida da Saudade - 225 18650000 São Manuel Brazil
Telephone: 14-38411284
Email: gluvizutto@fmb.unesp.br
Affiliation:  Gustavo José Luvizutto
Name: Gustavo  Luvizutto
Address:  Avenida da Saudade - 225 18650000 São Manuel Brazil
Telephone: 14-38411284
Email: gluvizutto@fmb.unesp.br
Affiliation:  Gustavo José Luvizutto
Key inclusion & exclusion criteria
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: -
Health Condition(s) or Problem(s) studied
Stroke
C10.228.140.300.775
Intervention(s)
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
Primary Outcome(s)
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).
Secondary Outcome(s)
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.
Secondary ID(s)
3495-2010
Source(s) of Monetary Support
Hospital das Clínicas da Faculdade de Medicina de Botucatu - Botucatu, SP, Brazil
Secondary Sponsor(s)
Hospital das Clínicas da Faculdade de Medicina de Botucatu - Botucatu, SP, Brazil
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