- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01911338
Inertial Sensors Used to Learn Manipulation
3 de dezembro de 2014 atualizado por: Dr. Antonio I Cuesta-Vargas, University of Malaga
EFFECT OF REAL-TIME FEEDBACK THROUGH INERTIAL SENSORS IN LEARNING POSTEROANTERIOR THORACIC MANIPULATION
- Background Context: no studies have been identified to analyse the effect of real time feedback (using inertial sensors) on physiotherapy students learning the art of posterior-anterior thoracic manipulation (PATM).
- Purpose: to study the effect caused by real-time feedback on the learning process for PATM, comparing two undergraduate physiotherapy student groups. Hypothesis: significant differences will exist in the execution parameters of manipulation among students receiving real-time feedback versus those who do not.
- Study Design/Setting: longitudinal, pre-post intervention.
- Patient Sample: Sixty-one undergraduate physiotherapy students were divided randomly into two groups, G1 (n = 31) (group without feedback in real time) and G2 (n = 30) (group with real-time feedback).
- Outcome Measures: time, displacement and velocity and improvement (only between groups) to reach maximum peak, to reach minimum peak from maximum peak, total manipulation time.
- Methods: two groups of physiotherapy students learned PATM, one using a traditional method and the other using real-time feedback (inertial sensor). Measures were obtained pre- and post-intervention. Intragroup pre- and post-intervention and intergroup post-intervention scores were calculated. An analysis of the measures' stability was developed through an ICC (1,2).
- Results: the values of ICC ranged from 0.881 to 0.997. Statistically significant differences were found in all variables analysed (intra- and inter-group) in favour of G2.
- Conclusions: the learning process for posterior-anterior thoracic manipulation is facilitated when the student receives real-time feedback.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
64
Estágio
- Não aplicável
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 65 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Participants did not have any training in manual therapy techniques, especially those involving a high velocity, low amplitude execution.
Exclusion Criteria:
- Refusal to participate in the study
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Real Time Feedback
Before beginning practice, one of the teachers performed the manipulation and explained the graph parameters as real-time feedback to consider when interpreting the graph, leaving the graphic as the benchmark execution
|
Before beginning practice, one of the teachers performed the manipulation and explained the graph parameters as real-time feedback to consider when interpreting the graph, leaving the graphic as the benchmark execution
|
|
Comparador Ativo: Tradicional Learning Method
Two expert teachers in manual therapy provided indications and corrections to the group with a teacher - student ratio of 1:8
|
Two expert teachers in manual therapy provided indications and corrections to the group with a teacher - student ratio of 1:8.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change from displacement maximum peak (seconds)
Prazo: baseline; post-education; 24 weeks follow up
|
An instrumented manikin (Resusci Anne Full Body with signal box, Laerdal Medical AS) joined an inertial sensor (Inertial Cube (Intersense Inc, USA)) was used to register the physical parameters during execution of the PATM.
The inertial sensor was placed in the middle of the thoracic spine, placing hands immediately below the sensor.
The manikin has a ribcage with a deformation capacity similar to that of a human thorax.
This option was chosen to minimize the power variation when comparing differences in parameters between different groups of students.
The inclusion criteria used were that they did not have any training in manual therapy techniques, especially those involving a high velocity, low amplitude execution.
|
baseline; post-education; 24 weeks follow up
|
|
Change from Time to reach maximum peak (seconds)
Prazo: baseline; post-education; 24 weeks follow up
|
An instrumented manikin (Resusci Anne Full Body with signal box, Laerdal Medical AS) joined an inertial sensor (Inertial Cube (Intersense Inc, USA)) was used to register the physical parameters during execution of the PATM.
The inertial sensor was placed in the middle of the thoracic spine, placing hands immediately below the sensor.
The manikin has a ribcage with a deformation capacity similar to that of a human thorax.
This option was chosen to minimize the power variation when comparing differences in parameters between different groups of students.
The inclusion criteria used were that they did not have any training in manual therapy techniques, especially those involving a high velocity, low amplitude execution.
|
baseline; post-education; 24 weeks follow up
|
|
Change from Displacement between maximum and minimum peak (milimitres)
Prazo: baseline; post-education; 24 weeks follow up
|
An instrumented manikin (Resusci Anne Full Body with signal box, Laerdal Medical AS) joined an inertial sensor (Inertial Cube (Intersense Inc, USA)) was used to register the physical parameters during execution of the PATM.
The inertial sensor was placed in the middle of the thoracic spine, placing hands immediately below the sensor.
The manikin has a ribcage with a deformation capacity similar to that of a human thorax.
This option was chosen to minimize the power variation when comparing differences in parameters between different groups of students.
The inclusion criteria used were that they did not have any training in manual therapy techniques, especially those involving a high velocity, low amplitude execution.
|
baseline; post-education; 24 weeks follow up
|
|
Change from Total manipulation time (seconds)
Prazo: baseline; post-education; 24 weeks follow up
|
An instrumented manikin (Resusci Anne Full Body with signal box, Laerdal Medical AS) joined an inertial sensor (Inertial Cube (Intersense Inc, USA)) was used to register the physical parameters during execution of the PATM.
The inertial sensor was placed in the middle of the thoracic spine, placing hands immediately below the sensor.
The manikin has a ribcage with a deformation capacity similar to that of a human thorax.
This option was chosen to minimize the power variation when comparing differences in parameters between different groups of students.
The inclusion criteria used were that they did not have any training in manual therapy techniques, especially those involving a high velocity, low amplitude execution.
|
baseline; post-education; 24 weeks follow up
|
|
Change from Velocity to reach maximum peak (degrees per second)
Prazo: baseline; post-education; 24 weeks follow up
|
An instrumented manikin (Resusci Anne Full Body with signal box, Laerdal Medical AS) joined an inertial sensor (Inertial Cube (Intersense Inc, USA)) was used to register the physical parameters during execution of the PATM.
The inertial sensor was placed in the middle of the thoracic spine, placing hands immediately below the sensor.
The manikin has a ribcage with a deformation capacity similar to that of a human thorax.
This option was chosen to minimize the power variation when comparing differences in parameters between different groups of students.
The inclusion criteria used were that they did not have any training in manual therapy techniques, especially those involving a high velocity, low amplitude execution.
|
baseline; post-education; 24 weeks follow up
|
|
Change from Time to reach peak minimum from maximum peak (seconds)
Prazo: baseline; post-education; 24 weeks follow up
|
An instrumented manikin (Resusci Anne Full Body with signal box, Laerdal Medical AS) joined an inertial sensor (Inertial Cube (Intersense Inc, USA)) was used to register the physical parameters during execution of the PATM.
The inertial sensor was placed in the middle of the thoracic spine, placing hands immediately below the sensor.
The manikin has a ribcage with a deformation capacity similar to that of a human thorax.
This option was chosen to minimize the power variation when comparing differences in parameters between different groups of students.
The inclusion criteria used were that they did not have any training in manual therapy techniques, especially those involving a high velocity, low amplitude execution.
|
baseline; post-education; 24 weeks follow up
|
|
Change from Velocity to reach minimum peak from maximum peak (degress/second)
Prazo: baseline; post-education; 24 weeks follow up
|
An instrumented manikin (Resusci Anne Full Body with signal box, Laerdal Medical AS) joined an inertial sensor (Inertial Cube (Intersense Inc, USA)) was used to register the physical parameters during execution of the PATM.
The inertial sensor was placed in the middle of the thoracic spine, placing hands immediately below the sensor.
The manikin has a ribcage with a deformation capacity similar to that of a human thorax.
This option was chosen to minimize the power variation when comparing differences in parameters between different groups of students.
The inclusion criteria used were that they did not have any training in manual therapy techniques, especially those involving a high velocity, low amplitude execution.
|
baseline; post-education; 24 weeks follow up
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Manuel González-Sánchez, PT, PhD, University of Malaga
- Investigador principal: Yves Lenfant, PT, University of Malaga
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de fevereiro de 2012
Conclusão Primária (Real)
1 de junho de 2012
Conclusão do estudo (Real)
1 de setembro de 2012
Datas de inscrição no estudo
Enviado pela primeira vez
23 de julho de 2013
Enviado pela primeira vez que atendeu aos critérios de CQ
29 de julho de 2013
Primeira postagem (Estimativa)
30 de julho de 2013
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
4 de dezembro de 2014
Última atualização enviada que atendeu aos critérios de controle de qualidade
3 de dezembro de 2014
Última verificação
1 de julho de 2013
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- ACuesta07072013
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 .