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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-34v9px
Date of registration: 16/02/2012
Primary sponsor: Universidade do Vale do SapucaĆ­ - Brazil
Public title: Analysis of the effect of vibration in patients with stroke
Scientific title: Analysis of the effects of low frequency vibration in patients affected by stroke
Date of first enrolment: 03/01/2011
Target sample size: 40
Recruitment status: recruitment completed
URL:  http://www.ensaiosclinicos.gov.br/rg/RBR-34v9px/
Study type:  Intervention
Study design:  Therapeutic, parallel, two arms, single- blinded, randomized trial  
Countries of recruitment
Brazil
Contacts
Name: Adriana   Silva
Address:  Benjamin Constant 93 37130000 Alfenas Brazil
Telephone: 3532911486
Email: adrianat.silva@yahoo.com.br
Affiliation:  Adriana Teresa Silva
Name: Adriana   Silva
Address:  Benjamin Constant 93 37130000 Alfenas Brazil
Telephone: 3532911486
Email: adrianat.silva@yahoo.com.br
Affiliation:  Adriana Teresa Silva
Key inclusion & exclusion criteria
Inclusion criteria: Hemiparesis due to stroke with more than 3 months of injury;
Age over 30 years;
Both sexes;
without distinction of race; color and socioeconomic;
Level with mental competence assessed by the mini-mental examination and reduction of motor function assessed by rating scale Fugl-Meyer.

Exclusion criteria: Younger than 30 years;
Acute cerebral vascular accident;
low level of mental competence;
Using pacemaker;
Uncontrolled hypertension.


Age minimum: 30Y
Age maximum: 80Y
Gender: -
Health Condition(s) or Problem(s) studied
G00-G99
Sequelae of stroke, Abnormality of gait and mobility
I69.4
R26
Intervention(s)
Will be selected 40 patients with sequelae of hemiparesis due to stroke, divided into 2 groups: control (10 untreated patients) and intervention (30 patients). In the intervention group will be applied to vibration therapy three times a week for 4 weeks. The application time in the first 2 weeks will be 4 minutes and the second week of 8 minutes with 1 minute rest between each application. The instrument will be used for treatment is a vibrating platform where the patient is placed on top with knee flexed to 30 degree at a frequency of 50Hz and amplitude of 2 mm. After 30 days of application will be a reassessment of the patients
Primary Outcome(s)
Improvement in lower limb function assessed using: standard of muscle contraction - performed by electromyography; runtime task of climbing stairs - stair-climbing test, time spent deslocamente from one place to another, test and timed up and walk away covered by a period of time - test 6 minutes.
Secondary Outcome(s)
Improvement in the running speed by using the test of 6 minutes and up and walk test timed.
Improves the speed to go up through the stair climbing test.
Secondary ID(s)
1499/10
Source(s) of Monetary Support
Adriana Teresa Silva - Brazil
Secondary Sponsor(s)
Universidade do Vale do SapucaĆ­ - Brazil
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