Cross-over Study of Three Modular Devices for Aid in Patient Standing and Transfer (VTT)
25 de março de 2015 atualizado por: Centre Hospitalier Universitaire de Nīmes
The main objective of this study is to evaluate via a physiological analysis of the movements involved in standing, the level of forward flexion of the spine (in cm on the horizontal axis) obtained with the apparatus "Tina" and to compare levels obtained in the same patients with stander/transfer devices "Turner" and "Vertic'Easy".
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
Secondary objectives of this study are to compare the three devices in terms of:
- the level recovery of the spine on the vertical axis (vertical displacement C7, cm)
- standing time, defined by the time between the start of the forward flexion and the beginning of the vertical stabilization phase (seconds)
- the success rate of the verticalization of the patient (the attempt is considered successful when the vertical position is held for 10 seconds).
Tipo de estudo
Intervencional
Inscrição (Real)
30
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Nîmes Cedex 09, França, 30029
- CHU de Nîmes - Hopital Universitaire Caremeau
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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
75 anos e mais velhos (Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient is in stable medical condition (no complications in the last 10 days)
- The patient is unable to stand up by his/her self and requires help during transfers
- The patient has muscular force (quadriceps) > 3 out of 5.
Exclusion Criteria:
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- The patient is pregnant, parturient, or breastfeeding
- The patient has a limited support from at least one lower limb
- The patient has an unstable fracture
- The patient has a fragile heart
- The patient has joint pain localized in the knee, hip or ankle.
- The patient has already used one of three mechanisms to help with standing and transfer used in this study
- Behavioral problems (opposition, agitation)
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
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Turner-Vertic'Easy-Tina
Standing will be attempted with the three devices in the following order: (1) Turner; (2) Vertic'Easy; (3) Tina.
|
Included patients had never used any of the three devices evaluated in this study.
Therefore the patient will make two attempts at standing on each device to enable him/her to get used to the device at the first attempt.
A video recording will be made from a camera positioned laterally.
Only the results of the second attempt will be a kinematic analysis and will be used for analyzes.
Outros nomes:
Included patients had never used any of the three devices evaluated in this study.
Therefore the patient will make two attempts at standing on each device to enable him/her to get used to the device at the first attempt.
A video recording will be made from a camera positioned laterally.
Only the results of the second attempt will be a kinematic analysis and will be used for analyzes
Outros nomes:
Included patients had never used any of the three devices evaluated in this study.
Therefore the patient will make two attempts at standing on each device to enable him/her to get used to the device at the first attempt.
A video recording will be made from a camera positioned laterally.
Only the results of the second attempt will be a kinematic analysis and will be used for analyzes
Outros nomes:
|
|
Experimental: Turner-Tina-Vertic'Easy
Standing will be attempted with the three devices in the following order: (1) Turner; (2) Tina; (3) Vertic'Easy.
|
Included patients had never used any of the three devices evaluated in this study.
Therefore the patient will make two attempts at standing on each device to enable him/her to get used to the device at the first attempt.
A video recording will be made from a camera positioned laterally.
Only the results of the second attempt will be a kinematic analysis and will be used for analyzes.
Outros nomes:
Included patients had never used any of the three devices evaluated in this study.
Therefore the patient will make two attempts at standing on each device to enable him/her to get used to the device at the first attempt.
A video recording will be made from a camera positioned laterally.
Only the results of the second attempt will be a kinematic analysis and will be used for analyzes
Outros nomes:
Included patients had never used any of the three devices evaluated in this study.
Therefore the patient will make two attempts at standing on each device to enable him/her to get used to the device at the first attempt.
A video recording will be made from a camera positioned laterally.
Only the results of the second attempt will be a kinematic analysis and will be used for analyzes
Outros nomes:
|
|
Experimental: Vertic'Easy-Turner-Tina
Standing will be attempted with the three devices in the following order: (1) Vertic'Easy; (2) Turner; (3) Tina.
|
Included patients had never used any of the three devices evaluated in this study.
Therefore the patient will make two attempts at standing on each device to enable him/her to get used to the device at the first attempt.
A video recording will be made from a camera positioned laterally.
Only the results of the second attempt will be a kinematic analysis and will be used for analyzes.
Outros nomes:
Included patients had never used any of the three devices evaluated in this study.
Therefore the patient will make two attempts at standing on each device to enable him/her to get used to the device at the first attempt.
A video recording will be made from a camera positioned laterally.
Only the results of the second attempt will be a kinematic analysis and will be used for analyzes
Outros nomes:
Included patients had never used any of the three devices evaluated in this study.
Therefore the patient will make two attempts at standing on each device to enable him/her to get used to the device at the first attempt.
A video recording will be made from a camera positioned laterally.
Only the results of the second attempt will be a kinematic analysis and will be used for analyzes
Outros nomes:
|
|
Experimental: Vertic'Easy-Tina-Turner
Standing will be attempted with the three devices in the following order: (1) Vertic'Easy; (2) Tina; (3) Turner.
|
Included patients had never used any of the three devices evaluated in this study.
Therefore the patient will make two attempts at standing on each device to enable him/her to get used to the device at the first attempt.
A video recording will be made from a camera positioned laterally.
Only the results of the second attempt will be a kinematic analysis and will be used for analyzes.
Outros nomes:
Included patients had never used any of the three devices evaluated in this study.
Therefore the patient will make two attempts at standing on each device to enable him/her to get used to the device at the first attempt.
A video recording will be made from a camera positioned laterally.
Only the results of the second attempt will be a kinematic analysis and will be used for analyzes
Outros nomes:
Included patients had never used any of the three devices evaluated in this study.
Therefore the patient will make two attempts at standing on each device to enable him/her to get used to the device at the first attempt.
A video recording will be made from a camera positioned laterally.
Only the results of the second attempt will be a kinematic analysis and will be used for analyzes
Outros nomes:
|
|
Experimental: Tina-Turner-Vertic'Easy
Standing will be attempted with the three devices in the following order: (1) Tina; (2) Turner; (3) Vertic'Easy.
|
Included patients had never used any of the three devices evaluated in this study.
Therefore the patient will make two attempts at standing on each device to enable him/her to get used to the device at the first attempt.
A video recording will be made from a camera positioned laterally.
Only the results of the second attempt will be a kinematic analysis and will be used for analyzes.
Outros nomes:
Included patients had never used any of the three devices evaluated in this study.
Therefore the patient will make two attempts at standing on each device to enable him/her to get used to the device at the first attempt.
A video recording will be made from a camera positioned laterally.
Only the results of the second attempt will be a kinematic analysis and will be used for analyzes
Outros nomes:
Included patients had never used any of the three devices evaluated in this study.
Therefore the patient will make two attempts at standing on each device to enable him/her to get used to the device at the first attempt.
A video recording will be made from a camera positioned laterally.
Only the results of the second attempt will be a kinematic analysis and will be used for analyzes
Outros nomes:
|
|
Experimental: Tina-Vertic'Easy-Turner
Standing will be attempted with the three devices in the following order: (1) Tina; (2) Vertic'Easy; (3) Turner.
|
Included patients had never used any of the three devices evaluated in this study.
Therefore the patient will make two attempts at standing on each device to enable him/her to get used to the device at the first attempt.
A video recording will be made from a camera positioned laterally.
Only the results of the second attempt will be a kinematic analysis and will be used for analyzes.
Outros nomes:
Included patients had never used any of the three devices evaluated in this study.
Therefore the patient will make two attempts at standing on each device to enable him/her to get used to the device at the first attempt.
A video recording will be made from a camera positioned laterally.
Only the results of the second attempt will be a kinematic analysis and will be used for analyzes
Outros nomes:
Included patients had never used any of the three devices evaluated in this study.
Therefore the patient will make two attempts at standing on each device to enable him/her to get used to the device at the first attempt.
A video recording will be made from a camera positioned laterally.
Only the results of the second attempt will be a kinematic analysis and will be used for analyzes
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Level of forward flexion of the spine (position of maximum horizontal displacement of C7)
Prazo: Baseline (Day 0; cross-sectional study)
|
cm
|
Baseline (Day 0; cross-sectional study)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Level of standing (maximum vertical displacement C7)
Prazo: Baseline (Day 0; transversal study)
|
cm
|
Baseline (Day 0; transversal study)
|
|
Angle of hip flexion (angle formed by the line connecting the acromion and the greater trochanter with the line connecting the greater trochanter and the lateral femoral condyle)
Prazo: Baseline (Day 0; transversal study)
|
degrees
|
Baseline (Day 0; transversal study)
|
|
Standing time (time from start of forward flexion and the beginning of the vertical stabilization phase)
Prazo: Baseline (Day 0; transversal study)
|
seconds
|
Baseline (Day 0; transversal study)
|
|
Verticalization achieved (yes/no)
Prazo: Baseline (Day 0; transversal study)
|
yes/no
|
Baseline (Day 0; transversal study)
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
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 setembro de 2012
Conclusão Primária (Real)
1 de novembro de 2012
Conclusão do estudo (Real)
1 de novembro de 2012
Datas de inscrição no estudo
Enviado pela primeira vez
17 de julho de 2012
Enviado pela primeira vez que atendeu aos critérios de CQ
23 de julho de 2012
Primeira postagem (Estimativa)
24 de julho de 2012
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
26 de março de 2015
Última atualização enviada que atendeu aos critérios de controle de qualidade
25 de março de 2015
Última verificação
1 de março de 2015
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- LOCAL/2012/EV-03
- 2012-A00638-35 (Outro identificador: RCB number)
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