6. ÖLÇÜMDE KULLANILAN EKİPMANLAR
6.3 dBFA Suite Paket Programı
6.3.1 FFT analizör
1) Título do estudo: Desempenho funcional global no autismo infantil e síndrome de Asperger: aplicabilidade do Inventário de Avaliação Pediátrica de Incapacidade (PEDI)
2) Essas informações estão sendo fornecidas para sua participação voluntária neste estudo, que visa efetividade do inventário de avaliação pediátrica de incapacidade no diagnóstico e diferenciação do transtorno autista e síndrome de Asperger dentre os Transtornos Invasivos do Desenvolvimento
3) O cuidador da criança (pai ou responsável) será submetido a uma entrevista estruturada com duração total de 45 a 60 minutos para informar sobre o desempenho típico da criança no cotidiano, avaliando três áreas de desempenho: auto-cuidado, mobilidade e função social; associado a observação clínica da criança.
4) Esta pesquisa apresenta risco mínimo para os participantes.
5) Este estudo tem o objetivo de avaliar o desempenho funcional global e a necessidade de assistência do cuidador no autismo infantil e na síndrome de Asperger; comparar o desempenho funcional global e assistência de cuidador destes dois grupos de pacientes com os dados normativos da população brasileira da mesma faixa etária e entre os dois grupos.
6) Em qualquer etapa do estudo, você terá acesso aos profissionais responsáveis pela pesquisa para esclarecimento de eventuais dúvidas. A principal investigadora é a fisioterapeuta Michele Gea Guimarães Pozzato, que pode ser encontrada na Rua Botucatu, 740 – Térreo, telefone 5575-52-40, ou 9521-79-92. Se você tiver alguma consideração ou dúvida sobre a ética da pesquisa, entre em contato com o Comitê de ética em pesquisa (CEP) – Rua Botucatu, 572 – 1º andar – cj 14,5571-1062, FAX: 5539-7162- Email:[email protected];
7) É garantida a liberdade de retirada de consentimento a qualquer momento e deixar de participar do estudo, sem qualquer prejuízo à continuidade de seu tratamento na Instituição;
8) As informações obtidas serão analisadas em conjunto com outros pacientes, não sendo divulgada a identificação de nenhum paciente;
9) O voluntário tem o direito de ser mantido atualizado sobre os resultados parciais das pesquisas, quando em estudos abertos, ou de resultados que sejam do conhecimento dos pesquisadores;
10) Não há despesas pessoais para o participante em qualquer fase do estudo. Também não há compensação financeira relacionada à sua participação. Se existir qualquer despesa adicional, ela será absorvida pelo orçamento da pesquisa;
11) É compromisso do pesquisador utilizar os dados coletados somente para esta pesquisa.
Acredito ter sido suficientemente informado a respeito das informações que li ou que foram lidas por mim, descrevendo o estudo “Desempenho funcional global no autismo infantil e síndrome de Asperger: aplicabilidade do Inventário de Avaliação Pediátrica de Incapacidade (PEDI)”.
Eu discuti com a Fisioterapeuta Michele Gea Guimarães Pozzato sobre a minha decisão em participar nesse estudo. Ficaram claros para mim quais são os propósitos deste estudo, o procedimento a ser realizado, sua confidencialidade e garantia de esclarecimentos permanentes. Ficou claro também que minha participação é isenta de despesas e que tenho garantia do acesso a tratamento hospitalar quando necessário. Concordo voluntariamente em participar deste estudo e poderei retirar o meu consentimento a qualquer momento, antes ou durante o mesmo, sem penalidades ou prejuízo ou perda de qualquer benefício para que eu possa ter adquirido, ou no meu atendimento neste Serviço.
__________________________________ Data___/___/___ Assinatura do paciente/representante legal
__________________________________ Data ___/___/___ Assinatura da testemunha
(Somente para o responsável do projeto)
Declaro que obtive de forma apropriada e voluntária o Consentimento Livre e Esclarecido deste paciente ou representante legal para a participação neste estudo.
_______________________________ Data___/____/___ Assinatura do responsável pelo estudo
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