- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05898555
Validación de Prendas Inteligentes para la Clasificación de la Marcha
Validación de Prendas Inteligentes para la Evaluación de la Marcha y el Equilibrio
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Ontario
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Waterloo, Ontario, Canadá, N2L3G1
- University of Waterloo - Engineering 7
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
A convenience-sample of 20 healthy individuals will be recruited for this study.
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Error in step length metric
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- Myant/Waterloo/42689
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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