- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT05898555
Validação de roupas inteligentes para classificação de marcha
Validação de roupas inteligentes para avaliação de marcha e equilíbrio
The aim of this study is therefore to validate Myant SKIIN garments for the purpose of gait and balance assessment. To achieve this, we recruit young healthy adults from the University of Waterloo to wear Skiin products (see Fig. 1). Participants will be asked to perform a number of scripted gait and balance tasks.
Visão geral do estudo
Descrição detalhada
Specific objectives of this study are:
- To validate Skiin gait characterization algorithm (based on single garment solutions - already developed based on a literature and a previous study conducted at the University of Waterloo);
- To develop algorithms for multi-garments solutions that aim to extract additional kinematic parameters such as joint angles.
Gait metrics from Skiin garments will be compared to metrics from a gold standard measurement (Vicon motion capture) to indicate accuracy, precision and reliability.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Ontario
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Waterloo, Ontario, Canadá, N2L3G1
- University of Waterloo - Engineering 7
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
A convenience-sample of 20 healthy individuals will be recruited for this study.
Descrição
Inclusion Criteria:
- Healthy male and female adults aged 18y - 64y old
Exclusion Criteria:
- Self-reported lower limb conditions, neurological disorders, history of concussion/brain trauma, and/or condition limiting exercise is to mitigate additional risk for injury and/or adverse reactions associated with exercise.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: PROSPECTIVE
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
Healthy individuals
Gait study protocol |
Participants will be asked to wear a Skiin smart garment over their own clothes. Small motion capture markers will be placed on their body and pressure-sensitive insoles placed into their shoes to measure the pressure underneath their feet during the study tasks. Once the sensors are ready for collection, participants will be asked to complete 5 tasks associated with their daily activities: 1. Locomotion; 2. Lower limb strength - repeated sit-to-stand-to-sit transitions; 3. Lower limb strength and locomotion - Timed Up and Go; 4. Free walking during a 2min walk; 5. Standing balance, postural control. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Error in step length metric
Prazo: Collection during the single study session of 1.5 hours.
|
The difference between step lengths calculated from Skiin data and from Vicon data for each scripted gait tasks. |
Collection during the single study session of 1.5 hours.
|
|
Error in stride length metric
Prazo: Collection during the single study session of 1.5 hours.
|
The difference between stride length calculated from Skiin data and from Vicon data for each scripted gait tasks. |
Collection during the single study session of 1.5 hours.
|
|
Error in cadence metric
Prazo: Collection during the single study session of 1.5 hours.
|
The difference between cadence calculated from Skiin data and from Vicon data for each scripted gait tasks. |
Collection during the single study session of 1.5 hours.
|
|
Error in step duration (s) metric, and its asymmetry
Prazo: Collection during the single study session of 1.5 hours.
|
The difference between step duration (s), and its asymmetry calculated from Skiin data and from Vicon data for each scripted gait tasks. |
Collection during the single study session of 1.5 hours.
|
|
Error in stride duration (s) metric, and its asymmetry
Prazo: Collection during the single study session of 1.5 hours.
|
The difference between stride duration (s), and its asymmetry calculated from Skiin data for each scripted gait tasks. |
Collection during the single study session of 1.5 hours.
|
|
Error in stance duration (s) metric, and its asymmetry
Prazo: Collection during the single study session of 1.5 hours.
|
The difference between stance duration (s), and its asymmetry calculated from Skiin data and from Vicon data for each scripted gait tasks. |
Collection during the single study session of 1.5 hours.
|
|
Error in swing duration (s) metric, and its asymmetry
Prazo: Collection during the single study session of 1.5 hours.
|
The difference between swing duration(s), and its asymmetry calculated from Skiin data and from Vicon data for each scripted gait tasks. |
Collection during the single study session of 1.5 hours.
|
|
Error in initial double support (s) metric, and its asymmetry
Prazo: Collection during the single study session of 1.5 hours.
|
The difference between double support (s), and its asymmetry calculated from Skiin data and from Vicon data for each scripted gait tasks. |
Collection during the single study session of 1.5 hours.
|
|
Error in terminal double support (s) metric, and its asymmetry
Prazo: Collection during the single study session of 1.5 hours.
|
The difference between terminal double support (s), and its asymmetry calculated from Skiin data and from Vicon data for each scripted gait tasks. |
Collection during the single study session of 1.5 hours.
|
|
Error in double support (s) metric, and its asymmetry
Prazo: Collection during the single study session of 1.5 hours.
|
The difference between double support (s), and its asymmetry calculated from Skiin data and from Vicon data for each scripted gait tasks. |
Collection during the single study session of 1.5 hours.
|
|
Error in single limb support (s) metric, and its asymmetry
Prazo: Collection during the single study session of 1.5 hours.
|
The difference between single limb support (s), and its asymmetry calculated from Skiin data and from Vicon data for each scripted gait tasks. |
Collection during the single study session of 1.5 hours.
|
|
Error in gait speed metric
Prazo: Collection during the single study session of 1.5 hours.
|
The difference between gait speed calculated from Skiin data and from Vicon data for each scripted gait tasks. |
Collection during the single study session of 1.5 hours.
|
|
Error in stride speed metric
Prazo: Collection during the single study session of 1.5 hours.
|
The difference between stride speed calculated from Skiin data and from Vicon data for each scripted gait tasks. |
Collection during the single study session of 1.5 hours.
|
|
Error in mean CoM sway distance
Prazo: Collection during the single study session of 1.5 hours.
|
The difference between sway distance of the Center of mass calculated from Skiin data and from Vicon data for each scripted balance tasks. |
Collection during the single study session of 1.5 hours.
|
|
Error in mean CoM sway velocity
Prazo: Collection during the single study session of 1.5 hours.
|
The difference between sway velocity of the Center of mass calculated from Skiin data and from Vicon data for each scripted balance tasks. |
Collection during the single study session of 1.5 hours.
|
|
Error in CoM sway area
Prazo: Collection during the single study session of 1.5 hours.
|
The difference between sway area of the Center of mass calculated from Skiin data and from Vicon data for each scripted balance tasks. |
Collection during the single study session of 1.5 hours.
|
|
Error in CoM sway frequency
Prazo: Collection during the single study session of 1.5 hours.
|
The difference between sway frequency of the Center of mass calculated from Skiin data and from Vicon data for each scripted balance tasks. |
Collection during the single study session of 1.5 hours.
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: James Tung, PhD, University of Waterloo
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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 (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- Myant/Waterloo/42689
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
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