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Desarrollo de un Controlador en Tiempo Real para Estimar el Rendimiento de la Marcha Utilizando un Exoesqueleto Bilateral de Tobillo

3 de noviembre de 2026 actualizado por: University of Nebraska

Desarrollo de un Controlador para Habilitar Asistencia Individualizada en Exoesqueletos Robóticos de Tobillo

This study is developing and testing a new controller for a robotic ankle exoskeleton (Biomotum) that can adjust itself in real time to better support people while they walk. The system learns how each person moves and automatically changes the amount and timing of assistance to make walking feel easier and more efficient. By using information from the person wearing the device, the exoskeleton can quickly find the level of support that works best for them. The long-term goal is to create personalized walking assistance that can help people with mobility limitations move more comfortably and with less effort.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

This project aims to develop and test a real-time adaptive controller for a robotic ankle exoskeleton (Biomotum) that personalizes assistance to each user by minimizing metabolic cost and optimizing muscle activation patterns during walking. Using human-in-the-loop optimization and advanced musculoskeletal modeling, the controller will dynamically adjust torque magnitude and timing to achieve optimal performance more quickly than current methods.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

6

Fase

  • No aplica

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.

Estudio Contacto

Ubicaciones de estudio

    • Nebraska
      • Omaha, Nebraska, Estados Unidos, 68108
        • Reclutamiento
        • Biomechanics Research Building, University of Nebraska at Omaha
        • Contacto:
        • Contacto:
        • Investigador principal:
          • Farah Fallahtafti, PhD
        • Sub-Investigador:
          • Arash Gonabadi, PhD
        • Sub-Investigador:
          • Sara Myers, PhD

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

19 años a 35 años (Adulto)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • able to walk independently on a treadmill for 10 minutes,
  • free of neurological, cardiovascular, pulmonary, or musculoskeletal conditions that limit walking and exercising,
  • no current lower extremity pain or injury,
  • able to wear an exoskeleton and safety harness, can provide informed consent

Exclusion Criteria:

  • history of neurological disease that affected gait or balance,
  • current or recent lower extremity musculoskeletal injury or surgery,
  • chronic lower extremity pain during walking,
  • inability to participate in moderate-intensity exercise,
  • require an assistive device for walking,
  • any metabolic or systemic diseases that may be exacerbated by 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

  • Propósito principal: Viabilidad del dispositivo
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Single-Arm Study of a Personalized Robotic Ankle Exoskeleton Controller

This arm employs a within-subject design with two methods of estimating metabolic cost versus the gold standard measure of metabolic cost, wherein a single participant is subjected to two distinct measurements. This design allows for a direct comparison of the effects of each method (i.e., estimation versus gold standard) within the same individual, minimizing intersubject variability and enhancing the statistical power of the analysis.

This intervention uses a robotic ankle exoskeleton equipped with a real-time adaptive controller that adjusts plantarflexion torque based on each participant's walking mechanics. Unlike standard exoskeleton controllers that use fixed or pre-programmed assistance levels, this system employs human-in-the-loop optimization to continuously update torque magnitude and timing during treadmill walking. The controller integrates metabolic estimations, kinematic data, and musculoskeletal modeling to identify individualized assistance patterns that reduce walking effort and improve muscle activation efficiency. Participants complete multiple walking trials while the controller automatically modifies assistance to determine the optimal personalized settings.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Successful Real-Time Operation of the Robotic Ankle Exoskeleton Controller
Periodo de tiempo: through study completion, an average of 1 year

Device feasibility will be evaluated by the successful real-time operation of the robotic ankle exoskeleton and adaptive controller during treadmill walking. Feasibility is defined as the controller's ability to continuously generate, update, and apply assistive torque in real time based on incoming biomechanical and physiological data without system failure, interruption, or safety-related termination. Successful operation will be confirmed by continuous controller function and synchronized data acquisition across walking trials.

through study completion, an average of 1 year

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Net Metabolic Rate During Exoskeleton-Assisted Walking Measured by Indirect Calorimetry
Periodo de tiempo: through study completion, an average of 1 year

Net oxygen consumption (VO₂) and carbon dioxide production (VCO₂) will be measured during treadmill walking using indirect calorimetry (Cosmed K5, Cosmed USA Inc., Chicago, IL). Metabolic rate will be calculated using standard equations during steady-state walking conditions. Measurements will be collected at regular intervals to characterize metabolic demand under different exoskeleton assistance configurations.

through study completion, an average of 1 year
Estimated Metabolic Rate Derived From Joint-Space Musculoskeletal Modeling
Periodo de tiempo: through study completion, an average of 1 year

Estimated metabolic rate will be derived from joint-space musculoskeletal models using kinematic and kinetic data collected during treadmill walking. Model-based estimates will be computed on a stride-by-stride basis to provide an indirect estimate of metabolic demand that can be compared with direct measurements from indirect calorimetry.

through study completion, an average of 1 year
Estimated Lower-Limb Muscle Activation Derived From Joint-Space Musculoskeletal Modeling
Periodo de tiempo: through study completion, an average of 1 year

Lower-limb muscle activation patterns will be estimated using joint-space musculoskeletal models based on motion capture and ground reaction force data collected during treadmill walking. Estimated muscle activation values will be computed on a stride-by-stride basis to characterize neuromuscular engagement during exoskeleton-assisted gait.

through study completion, an average of 1 year
Lower-Limb Muscle Activation Measured by Surface Electromyography During Walking
Periodo de tiempo: through study completion, an average of 1 year

Muscle activation of lower-limb muscles (e.g., tibialis anterior, gastrocnemius medialis, gastrocnemius lateralis, soleus) will be measured during treadmill walking using surface electromyography (Delsys). EMG signals will be collected continuously and processed to quantify muscle activation patterns during exoskeleton-assisted gait.

through study completion, an average of 1 year
During treadmill walking trials conducted at a single study visit
Periodo de tiempo: through study completion, an average of 1 year

Controller parameter convergence will be assessed during human-in-the-loop optimization trials by evaluating changes in controller gain and timing parameters across successive walking bouts. Convergence is defined as stabilization of controller parameters within a predefined range during the optimization process.

through study completion, an average of 1 year

Colaboradores e Investigadores

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

Patrocinador

Colaboradores

Investigadores

  • Investigador principal: Farah Fallahtafti, PhD, Department of Biomechanics, University of Nebraska at Omaha

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)

15 de agosto de 2026

Finalización primaria (Estimado)

1 de agosto de 2028

Finalización del estudio (Estimado)

1 de diciembre de 2028

Fechas de registro del estudio

Enviado por primera vez

5 de diciembre de 2025

Primero enviado que cumplió con los criterios de control de calidad

30 de enero de 2026

Publicado por primera vez (Actual)

6 de febrero de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de noviembre de 2026

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

3 de noviembre de 2026

Última verificación

1 de diciembre de 2025

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 0587-25-FB
  • 55136 (Otro número de subvención/financiamiento: Nebraska Research Initiative)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

IPD will not be shared because direct measurements are only taken for baseline measurements that the modeling software will be using. The scripts and code used will be shared through opensource, but that does not include subject data.

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.

Sí

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. .