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Validación de Prendas Inteligentes para la Clasificación de la Marcha

5 de octubre de 2026 actualizado por: Myant Medical Corp.

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

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Specific objectives of this study are:

  1. 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);
  2. 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

De observación

Inscripción (Actual)

20

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Ontario
      • Waterloo, Ontario, Canadá, N2L3G1
        • University of Waterloo - Engineering 7

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 64 años (Adulto)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

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

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Colaboradores

Investigadores

  • Investigador principal: James Tung, PhD, University of Waterloo

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

26 de mayo de 2023

Finalización primaria (Actual)

18 de septiembre de 2023

Finalización del estudio (Actual)

14 de marzo de 2024

Fechas de registro del estudio

Enviado por primera vez

1 de junio de 2023

Primero enviado que cumplió con los criterios de control de calidad

1 de junio de 2023

Publicado por primera vez (Actual)

12 de junio de 2023

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

5 de octubre de 2026

Última verificación

1 de marzo de 2024

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • Myant/Waterloo/42689

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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