- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03002285
Fitts Law in People With Cerebral Palsy
Evaluation of Speed-accuracy Trade-off in a Computer Task in Individuals With Cerebral Palsy
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
The software used in this study was "Fitts' Reciprocal Aiming Task v.1.0 (Horizontal)" developed by Okazaki, in the public domain and available on the Internet, which was performed on a Toshiba notebook®, model Satellite A60-S1561 System Unit, with the use of an external optical mouse, Fortrek® OM-302.
This instrument can be used to verify motor control through analysis of the speed and accuracy of movement, which can be determined through the log-linear relation between movement time and task difficulty using a mathematical equation, and analyzed by Fitts' law, which describes the relation between movement accuracy and speed, associated with target size and distance11. Thus, the task used in this study was composed of targets of different sizes, being that the smaller targets require more time to execute due to the necessity of increased accuracy and, if the distance between targets reduces, the speed of movement becomes greater and the accuracy decreases.
In relation to target size (W) and distance between targets (D), the equation log2 (2D/W) results in an index of difficulty (ID), where the higher the ID, the more difficult the task, a fact that necessitates greater movement time.
To evaluate the speed and accuracy, two different indices of difficulty were used in this study (ID2 and ID4). The difficulty level was increased by changing the width and distance between the bars. In addition, ID4 was used in two different ways (ID4a and ID4b), for which the distance between the bars and the width were different, but the ID was maintained.
3 Procedure and design The experiment was composed of three trials at each of the two IDs: 2 and 4 (ID 4 had two kinds of measurement - ID4a and ID4b), and the participants performed the tasks individually in a room, with only the evaluator present, seated on a chair (or their own wheelchair), which was adjusted in height according to the needs of the individual. A footrest was available, when necessary. The computer was placed on a table, and each participant was given instructions and presented with the task, in which the individual, after hearing an alarm from the computer, was required to click with an external mouse cursor on two parallel bars which were arranged vertically, intermittently, with the greatest speed and accuracy possible, for a period of 10 seconds, followed by a second alarm which indicated the end of the attempt.
Directly following the attempt, the total movement time was registered, by dividing the seconds obtained in each attempt by the number of "clicks" on targets. If more than two clicks were wrong, the individual repeated the task.
Procedure and design The experiment was composed of three trials at each of the two IDs: 2 and 4 (ID 4 had two kinds of measurement - ID4a and ID4b), and the participants performed the tasks individually in a room, with only the evaluator present, seated on a chair (or their own wheelchair), which was adjusted in height according to the needs of the individual. A footrest was available, when necessary. The computer was placed on a table, and each participant was given instructions and presented with the task, in which the individual, after hearing an alarm from the computer, was required to click with an external mouse cursor on two parallel bars which were arranged vertically, intermittently, with the greatest speed and accuracy possible, for a period of 10 seconds, followed by a second alarm which indicated the end of the attempt.
Directly following the attempt, the total movement time was registered, by dividing the seconds obtained in each attempt by the number of "clicks" on targets. If more than two clicks were wrong, the individual repeated the task.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- medical diagnosis of CP;
- levels I to IV according to the GMFCS;
- levels I to III according to MACS.
Exclusion Criteria:
- presence of surgery or a chemical neuromuscular blockade in the upper limbs within six months prior to participation in the study;
- lack of comprehension of the experimental instructions.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Cerebral Palsy group
Group with Cerebral Palsy that performed the Fitts law in a computer task
|
Group with Cerebral Palsy that performed the Fitts law in a computer task
|
|
Comparador Ativo: Control group
Group with typical development that performed the Fitts law in a computer task
|
Group with typical development that performed the Fitts law in a computer task
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Motor control test by using a fitts law task in computational task
Prazo: one day
|
one day
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Carlos BM Monteiro, Ph.D., University of Sao Paulo
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 14652713.9.0000.0082
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Paralisia cerebral
-
Ankara City Hospital BilkentRecrutamentoParalisia Cerebral (PC) | Paralisia Cerebral, Espástica, Diplégica | Paralisia Cerebral Diplégica com Espasticidade | Estimulação Magnética TranscranianaTurquia (Türkiye)
-
Suleyman Demirel UniversityConcluídoParalisia cerebral | Paralisia Cerebral Hemiplégica | Paralisia Cerebral Diplegia EspásticaTurquia (Türkiye)
-
Holland Bloorview Kids Rehabilitation HospitalCanadian Institutes of Health Research (CIHR)RecrutamentoParalisia Cerebral (PC) | Paralisia Cerebral HemiplégicaCanadá
-
University of Colorado, DenverConcluídoFluxo Sanguíneo Cerebral | Função cerebralEstados Unidos
-
Cairo UniversityConcluídoParalisia Cerebral (PC) | Paralisia Cerebral UnilateralEgito
-
University of California, San FranciscoAinda não está recrutandoParalisia cerebral | Paralisia Cerebral (PC) | Infantil | Paralisia Cerebral InfantilEstados Unidos
-
Ankara Ataturk Sanatorium Training and Research...Ainda não está recrutandoOximetria Cerebral Intraoperatória | Monitorização da Oxigenação CerebralTurquia (Türkiye)
-
UMC UtrechtConcluídoCirculação extracorpórea | Perfusão Cerebral | Oxigenação CerebralHolanda
-
Lahore University of Biological and Applied SciencesAinda não está recrutandoParalisia Cerebral Diplegia EspásticaPaquistão
-
Maastricht University Medical CenterNational Dairy CouncilAinda não está recrutandoFluxo Sanguíneo Cerebral | Performance cognitiva | Microbiota Intestinal | Controle de apetite | Função Vascular Cerebral | Sensibilidade cerebral à insulinaHolanda
Ensaios clínicos em Cerebral Palsy group
-
Izmir Democracy UniversityRecrutamento
-
Saglik Bilimleri UniversitesiAinda não está recrutandoEfeito da reflexologia nos sintomas da síndrome pré -menstrual
-
Cairo UniversityConcluídoEsclerose Múltipla Remitente-RecorrenteEgito
-
Aarhus University HospitalUniversity of AarhusConcluídoCâncer de Mama Feminino | Medo da recorrência do câncerDinamarca
-
Cukurova UniversityConcluídoGravidez de alto risco | Estado de ansiedade | Qualidade do SonoPeru
-
Tarsus UniversityRecrutamento
-
University of NottinghamRecrutamento
-
Washington University School of MedicineAtivo, não recrutandoGravidez relacionada | Depressão perinatalEstados Unidos
-
Arizona Oncology ServicesDesconhecidoCâncer de Mama Localizado | Câncer de Próstata Localizado | Pacientes recebendo radioterapia de feixe externoEstados Unidos
-
Trakya UniversityAinda não está recrutandoDor e Respostas Emocionais em Crianças Durante a Colheita de Sangue Venoso