- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07393971
Desenvolvimento de um Controlador em Tempo Real para Estimar o Desempenho da Marcha Utilizando um Exoesqueleto Bilateral do Tornozelo
Desenvolvimento de Controlador para Permitir Assistência Individualizada em Exoesqueletos Robóticos de Tornozelo
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Farah Fallahtafi, PhD
- Número de telefone: 4025543075
- E-mail: ffallahtafti@unomaha.edu
Locais de estudo
-
-
Nebraska
-
Omaha, Nebraska, Estados Unidos, 68108
- Recrutamento
- Biomechanics Research Building, University of Nebraska at Omaha
-
Contato:
- Farah Fallahtafti, PhD
- Número de telefone: 4025543075
- E-mail: ffallahtafti@unomaha.edu
-
Contato:
- Sara Myers, PhD
- Número de telefone: 4025543246
- E-mail: samyers@unomaha.edu
-
Investigador principal:
- Farah Fallahtafti, PhD
-
Subinvestigador:
- Arash Gonabadi, PhD
-
Subinvestigador:
- Sara Myers, PhD
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Viabilidade do dispositivo
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Successful Real-Time Operation of the Robotic Ankle Exoskeleton Controller
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Net Metabolic Rate During Exoskeleton-Assisted Walking Measured by Indirect Calorimetry
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Farah Fallahtafti, PhD, Department of Biomechanics, University of Nebraska at Omaha
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
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
- 0587-25-FB
- 55136 (Número de outro subsídio/financiamento: Nebraska Research Initiative)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano 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.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .