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

<!DOCTYPE trials SYSTEM "http://localhost:8000/xml/opentrials.dtd">
<trials version="1">
    
    <trial language="en"
           status="published"
           date_registration="2012-03-13"
           created="2012-02-09"
           updated="2012-12-20">
        <trial_identification>
            <trial_id>RBR-9x5jfn</trial_id>
            <utrn_number>U1111-1127-4957</utrn_number>
            <reg_name>REBEC</reg_name>
            <public_title>Effects of manipulation of foot muscles in people who have acquired brain injury</public_title>
            <acronym></acronym>
            <acronym_expansion></acronym_expansion>
            <scientific_title>Manipulation of intrinsic muscles of the foot in people with acquired brain injury</scientific_title>
            <scientific_acronym></scientific_acronym>
            <scientific_acronym_expansion></scientific_acronym_expansion>
        </trial_identification>

        <sponsors_and_support>
            <primary_sponsor country_code="BR" type="other">
                <name>Centro Universitário de Rio Preto - UNIRP</name>
                <address>Av. Clóvis Oger, 666, Distrito Industrial, Sao Jose do Rio Preto, Sao Paulo, CEP 15035-580 </address>
                <state></state>
                <city></city>
            </primary_sponsor>

            
            <secondary_sponsor country_code="BR" type="other">
                <name>Centro Universitário de Rio Preto - UNIRP</name>
                <address>Av. Clóvis Oger, 666, Distrito Industrial, Sao Jose do Rio Preto, Sao Paulo, CEP 15035-580 </address>
                <state></state>
                <city></city>
            </secondary_sponsor>
            

            
            <source_support country_code="BR" type="other">
                <name>Centro Universitário de Rio Preto - UNIRP</name>
                <address>Av. Clóvis Oger, 666, Distrito Industrial, Sao Jose do Rio Preto, Sao Paulo, CEP 15035-580 </address>
                <state></state>
                <city></city>
            </source_support>
            
        </sponsors_and_support>

        <health_conditions>
            
            <hc_code vocabulary="decs" version="" code="C10">
                <text>Nervous system diseases</text>
                
                
                <text_translation lang="es">Enfermedades del sistema nervioso</text_translation>
                
                <text_translation lang="pt-br">Doenças do sistema nervoso</text_translation>
                
                
            </hc_code>
            

            
            <keyword vocabulary="decs" version="" code="C10.228.140.199">
                <text>Brain Injuries</text>
                
                
                <text_translation lang="es">Traumatismos Encefálicos</text_translation>
                
                <text_translation lang="pt-br">Traumatismos Encefálicos</text_translation>
                
                
            </keyword>
            

            <freetext>Brain Injuries</freetext>
        </health_conditions>

        <interventions>
            
            <i_code value="other"></i_code>
            

            
            <keyword vocabulary="decs" version="" code="H02.010.625">
                <text>Physical Therapy Specialty</text>
                
                
                <text_translation lang="es">Fisioterapia</text_translation>
                
                <text_translation lang="pt-br">Fisioterapia</text_translation>
                
                
            </keyword>
            
            <keyword vocabulary="decs" version="" code="E02.190.599.500">
                <text>Massage</text>
                
                
                <text_translation lang="es">Masaje</text_translation>
                
                <text_translation lang="pt-br">Massagem</text_translation>
                
                
            </keyword>
            

            <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.</freetext>
        </interventions>

        <recruitment status="other">
            
            <recruitment_country value="BR"></recruitment_country>
            

            <inclusion_criteria>Patients with acquired brain injury;
Ability to stay in standing position without assistance of the upper limbs.</inclusion_criteria>
            <exclusion_criteria>Do not assume standing position; 
Age below 18 years; 
Owning a pathology that prevents the collection of results.</exclusion_criteria>
            <gender value="both"></gender>
            <agemin value="18" unit="years"></agemin>
            <agemax value="60" unit="years"></agemax>

            
            <date_enrolment_actual start="2011-02-09" end="None"></date_enrolment_actual>
            

            <target_size value="9"></target_size>
        </recruitment>

        <study expanded_access_program="None"
               number_of_arms="1">
            <study_design>Therapeutic clinical trial, single arm, open.</study_design>
            <type value="Intervention"></type>
            <phase value="null"></phase>
            <purpose value="treatment"></purpose>
            <intervention_assignment value="single-group"></intervention_assignment>
            <masking value="open"></masking>
            <allocation value="single-arm-study"></allocation>
        </study>

        <outcomes>
            
            <primary_outcome value="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.">
                
                <outcome_translation value="" lang="es"></outcome_translation>
                
                <outcome_translation value="Aumento da área de contato da superfície plantar após a manipulação da musculatura do pé. Para avaliação dos resultados será utilizado um baropodômetro calibrado com tempo de 15 segundos para cada análise." lang="pt-br"></outcome_translation>
                
            </primary_outcome>
            

            
            <secondary_outcome value="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.">
                
                <outcome_translation value="" lang="es"></outcome_translation>
                
                <outcome_translation value="Espera-se melhora do equilibrio após a manipulação da musculatura do pé. Para avaliação dos resultados será utilizado um baropodômetro calibrado com tempo de 15 segundos para cada análise." lang="pt-br"></outcome_translation>
                
            </secondary_outcome>
            
        </outcomes>

        <contacts>
            
            <person pid="606" country_code="BR">
                <firstname>Ana Elisa</firstname>
                <middlename>Zuliani</middlename>
                <lastname>Stroppa Marques</lastname>
                <address>Av. Clóvis Oger, 900</address>
                <city>São José do Rio Preto</city>
                <zip>15035-580</zip>
                <telephone>+551732116060</telephone>
                <email>anastropa@hotmail.com</email>
                
                <affiliation country_code="BR" type="other">
                    <name>Centro Universitário de Rio Preto - UNIRP</name>
                    <address>Av. Clóvis Oger, 666, Distrito Industrial, Sao Jose do Rio Preto, Sao Paulo, CEP 15035-580 </address>
                </affiliation>
                
            </person>
            
            <person pid="615" country_code="BR">
                <firstname>João </firstname>
                <middlename>Simão</middlename>
                <lastname>Melo Neto</lastname>
                <address>Av. Joaquim Manoel Pires</address>
                <city>São José do Rio Preto</city>
                <zip>15090-230</zip>
                <telephone>(17)33054971</telephone>
                <email>joaosimao03@hotmail.com</email>
                
                <affiliation country_code="BR" type="higher_education_institution">
                    <name>Faculdade de Medicina de Marília</name>
                    <address>Av. Monte Carmelo, 800 
CEP 17519-030</address>
                </affiliation>
                
            </person>
            

            
            <public_contact person="606"></public_contact>
            
            <public_contact person="615"></public_contact>
            

            
            <scientific_contact person="615"></scientific_contact>
            

            
            <site_contact person="606"></site_contact>
            
        </contacts>

        <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>

        <references>
            <link url="http://www.ensaiosclinicos.gov.br/rg/RBR-9x5jfn/v1/"></link>
        </references>

        
        
        <translation lang="es">
            <public_title></public_title>
            <acronym></acronym>
            <acronym_expansion></acronym_expansion>
            <scientific_title></scientific_title>
            <scientific_acronym></scientific_acronym>
            <scientific_acronym_expansion></scientific_acronym_expansion>
            <hc_freetext></hc_freetext>
            <i_freetext></i_freetext>
            <inclusion_criteria></inclusion_criteria>
            <exclusion_criteria></exclusion_criteria>
            <study_design></study_design>
        </translation>
        
        <translation lang="pt-br">
            <public_title>Efeitos da manipulação dos músculos do pé em pessoas que adquiriram lesão encefálica</public_title>
            <acronym></acronym>
            <acronym_expansion></acronym_expansion>
            <scientific_title>Manipulação dos músculos intrínsecos do pé em portadores de lesão encefálica adquirida</scientific_title>
            <scientific_acronym></scientific_acronym>
            <scientific_acronym_expansion></scientific_acronym_expansion>
            <hc_freetext>Traumatismos Encefálicos</hc_freetext>
            <i_freetext>Estudo realizado com nove pacientes adultos que conseguem ficar de pé sem ajuda dos membros superiores. Foi realizada avaliação e reavaliação (logo após  a manipulação da musculatura intrínseca do pé) por meio de baropodometria. A manipulação foi realizada com as mãos do fisioterapeuta posicionadas na região de bordo medial a bordo lateral do pé tracionando da região de retro pé em direção ao ante-pé, alternadamente. O tempo estipulado para cada manipulação foi de 15 segundos e para cada deslizamento cinco  repetições.</i_freetext>
            <inclusion_criteria>Portadores de lesão encefálica adquirida; 
Capacidade para ficar em ortostatismo sem auxílio dos membros superiores.</inclusion_criteria>
            <exclusion_criteria>Não assumir ortostatismo; 
Idade inferior a 18 anos; 
Possuir outra patologia que impeça a coleta dos resultados.</exclusion_criteria>
            <study_design>Ensaio clínico terapêutico, de braço unico, aberto.</study_design>
        </translation>
        
        
    </trial>
    
</trials>


