<?xml version="1.0" encoding="UTF-8"?>

<trials>

    <trial>
        <main>
            <trial_id>RBR-9x5jfn</trial_id>
            <utrn>U1111-1127-4957</utrn>
            <reg_name>REBEC</reg_name>
            <date_registration>13/03/2012</date_registration>
            <primary_sponsor>Centro Universitário de Rio Preto - UNIRP - Brazil</primary_sponsor>
            <public_title>Effects of manipulation of foot muscles in people who have acquired brain injury</public_title>
            <acronym></acronym>
            <scientific_title>Manipulation of intrinsic muscles of the foot in people with acquired brain injury</scientific_title>
            <scientific_acronym></scientific_acronym>
            <date_enrolment>09/02/2011</date_enrolment>
            <type_enrolment>actual</type_enrolment>
            <target_size>9</target_size>
            <recruitment_status>other</recruitment_status>
            <url>http://www.ensaiosclinicos.gov.br/rg/RBR-9x5jfn/</url>
            <study_type>Intervention</study_type>
            <study_design>Therapeutic clinical trial, single arm, open.</study_design>
            <phase>N/A</phase>
            <hc_freetext>Brain Injuries</hc_freetext>
            <i_freetext>A study conducted with nine adult patients who can stand up without help of the upper limbs. Evaluation and re-evaluation (was performed immediately after the manipulation of the intrinsic muscles of the foot) through baropodometry. The manipulation was performed with the hands of the physiotherapist positioned in the region of the medial edge of the lateral edge of the foot pulling the region of back foot towards the forefoot alternately. The time set for each operation was 15 seconds and five replicates for each slide.</i_freetext>            
        </main>
        <contacts>
        
            <contact>
                <type>public</type>
                <firstname>Ana Elisa</firstname>
                <middlename>Zuliani</middlename>
                <lastname>Stroppa Marques</lastname>
                <address>Av. Clóvis Oger, 900</address>
                <city>São José do Rio Preto</city>
                <country1>Brazil</country1>
                <zip>15035-580</zip>
                <telephone>+551732116060</telephone>
                <email>anastropa@hotmail.com</email>
                <affiliation>Centro Universitário de Rio Preto - UNIRP</affiliation>
            </contact>
        
            <contact>
                <type>public</type>
                <firstname>João </firstname>
                <middlename>Simão</middlename>
                <lastname>Melo Neto</lastname>
                <address>Av. Joaquim Manoel Pires</address>
                <city>São José do Rio Preto</city>
                <country1>Brazil</country1>
                <zip>15090-230</zip>
                <telephone>(17)33054971</telephone>
                <email>joaosimao03@hotmail.com</email>
                <affiliation>Faculdade de Medicina de Marília</affiliation>
            </contact>
        
        
            <contact>
                <type>scientific</type>
                <firstname>João </firstname>
                <middlename>Simão</middlename>
                <lastname>Melo Neto</lastname>
                <address>Av. Joaquim Manoel Pires</address>
                <city>São José do Rio Preto</city>
                <country1>Brazil</country1>
                <zip>15090-230</zip>
                <telephone>(17)33054971</telephone>
                <email>joaosimao03@hotmail.com</email>
                <affiliation>Faculdade de Medicina de Marília</affiliation>
            </contact>
        
        </contacts>
        <countries>
        
            <country2>Brazil</country2>
        
        </countries>
        <criteria>
            <inclusion_criteria>Patients with acquired brain injury;
Ability to stay in standing position without assistance of the upper limbs.</inclusion_criteria>
            <agemin>18Y</agemin>
            <agemax>60Y</agemax>
            <gender>-</gender>
            <exclusion_criteria>Do not assume standing position; 
Age below 18 years; 
Owning a pathology that prevents the collection of results.</exclusion_criteria>
        </criteria>
        <health_condition_code>
            
            <hc_code>C10</hc_code>
            
        </health_condition_code>
        <health_condition_keyword>
            
            <hc_keyword>C10.228.140.199</hc_keyword>
            
        </health_condition_keyword>
        <intervention_code>
            
            <i_code>other</i_code>
            
        </intervention_code>
        <intervention_keyword>
            
            <i_keyword>H02.010.625</i_keyword>
            
            <i_keyword>E02.190.599.500</i_keyword>
            
        </intervention_keyword>
        <primary_outcome>
            
            <prim_outcome>Increased contact area of the plantar surface after manipulation of the muscles of the foot. To evaluate the results will be used baropodômetro calibrated with a time of 15 seconds for each analysis.</prim_outcome>
            
        </primary_outcome>
        <secondary_outcome>
            
            <sec_outcome>Expected to improve the balance after manipulation of the muscles of the foot. To evaluate the results will be used baropodômetro calibrated with a time of 15 seconds for each analysis.</sec_outcome>
            
        </secondary_outcome>
        <secondary_sponsor>
            
            <sponsor_name>Centro Universitário de Rio Preto - UNIRP - Brazil</sponsor_name>
            
        </secondary_sponsor>
        <secondary_ids>
            
            <secondary_id>
                <sec_id>3770/2008</sec_id>
                <issuing_authority>Comitê de Ética em Pesquisa da Faculdade de Medicina de Rio Preto</issuing_authority>    
            </secondary_id>
            
        </secondary_ids>
        <source_support>
            
            <source_name>Centro Universitário de Rio Preto - UNIRP - Brazil</source_name>
            
        </source_support>        
    </trial>

</trials>


