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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-6d342s
Date of registration: 08/05/2012
Primary sponsor: Universidade Nove de Julho - Brazil
Public title: Insoles for use of assistance for everyday tasks in children with cerebral palsy.
Scientific title: Insoles postural functionality of children with cerebral palsy randomized controlled trial.
Date of first enrolment: 15/05/2012
Target sample size: 24
Recruitment status: not yet recruiting
URL:  http://www.ensaiosclinicos.gov.br/rg/RBR-6d342s/
Study type: 
Study design:  Clinical trial, randomized, controlled, single blinded trial  
Countries of recruitment
Brazil
Contacts
Name: Hugo  Pasini Neto
Address:  Rua Vergueiro, 235 01504-000 São Paulo Brazil
Telephone: 11-33859000
Email: hugopneto@yahoo.com.br
Affiliation:  Universidade Nove de Julho
Name: Hugo  Pasini Neto
Address:  Rua Vergueiro, 235 01504-000 São Paulo Brazil
Telephone: 11-33859000
Email: hugopneto@yahoo.com.br
Affiliation:  Universidade Nove de Julho
Key inclusion & exclusion criteria
Inclusion criteria: To participate in the study, the children will be diagnosed with cerebral palsy, ranked among the levels of the GMFCS I and II and have to walk independently without the need for auxiliary resources (walker or crutches).
Exclusion criteria: Children with CP who have undergone surgical procedures or the application of phenol in the last 12 months or neurolytic blocks in the last six months, children with cognitive and visual disabilities that may interfere with the performance of tasks, children with deformities of the ankle is not reducible to neutral and obese children.

Age minimum: 4Y
Age maximum: 12Y
Gender: -
Health Condition(s) or Problem(s) studied
Cerebral palsy
G80
Intervention(s)
24 children with cerebral palsy will be randomly divided into two groups and in the first make use of orthoses fixed polypropylene and the second will use the orthosis in a time of day (6 hours) and the remainder will make use of an postural insole made for their dysfunction.
Primary Outcome(s)
Evaluation of the effect of insoles on postural gait of children with cerebral palsy.
For this analysis will be performed three-dimensional gait and cadence (steps per minute) the parameter to be evaluated.
Secondary Outcome(s)
Evaluation of the effect of insoles on postural function of children with cerebral palsy.
It will be used for functional scales, such as the scale of Berg, team up and go test and 6 minute walk.
Evaluation of the effect of the insole postural balance of children with cerebral palsy.
To this will be accomplished and the parameter used to stabilometry the oscillation of the center of pressure.
Secondary ID(s)
436960
Source(s) of Monetary Support
Universidade Nove de Julho - Brazil
Secondary Sponsor(s)
Universidade Nove de Julho - Brazil
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