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Investigation of Motorized Lower-limb Prostheses

7 de maio de 2026 atualizado por: Northern Arizona University

The goal of this clinical trial is to learn if a motorized prosthesis can improve mobility in individuals with amputation. The main question it aims to answer is:

  • Does motorized prosthesis improve ambulation speed, balance, control, or efficiency when performing everyday activities?
  • What problems arise when using a motorized prosthesis? Researchers will compare mobility of the participants when using and not using the motorized prosthesis to see if mobility and/or function improves.

Participants will perform various activities with and without the motorized prosthesis including:

  • Walking at a mild incline/decline (0°-15°) on treadmill or over-ground
  • Ascending or descending stairs
  • Stand to sit and sit to stand transitions
  • All terrain walking over ground
  • Turning
  • Any combination of the above-mentioned activities

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

Participants will perform ambulation activities (see list below) while using their prescribed prosthesis or the motorized prosthesis in conjunction with their prescribed passive prosthesis. Each ambulation activity will be tested in four different conditions:

  1. Ambulation with their personal (take home) device. This condition acts as a baseline to which the ambulation with the motorized prosthesis can be compared.
  2. Ambulation with the motorized prosthesis in the "off" configuration (i.e., no power is applied to the motor). This condition demonstrates the impact of the device when it is unpowered.
  3. Ambulation with the motorized prosthesis in the "transparent" configuration (i.e., minimal power is applied to the motor, such that the device behaves as a free hinge). This condition demonstrates the impact of the device when it behaves as a free hinge, similar to the participants personal device.
  4. Ambulation with the motorized prosthesis in the "powered" configuration (i.e., substantial electrical power is applied to the motor to replicate the function of the biological joint). This condition assesses the impact of the motorized prosthesis to improve ambulation of the participant.

Trials will take place over-ground and/or on a treadmill. Participants will walk for up to 40 minutes. Frequent breaks will be provided between trials and conditions to avoid fatigue and a maximum of 15 minutes of continuous walking will take place between breaks. When deemed necessary by the research staff or participant, crutches, canes, walkers, an overhead support system, or other ambulation or safety aid will be used to minimize the risk of a severe fall.

List of ambulation activities

  1. Walking at a mild incline/decline (0°-15°) on treadmill or over-ground
  2. Ascending or descending stairs
  3. Stand to sit and sit to stand transitions
  4. All terrain walking over ground
  5. Turning
  6. Any combination of the above-mentioned activities

The above conditions will be assessed using motion capture techniques in the laboratory environment which will include measures of metabolic energy consumption and muscle activity.

All terrain walking over ground will take place on campus and include Engineering, Business, and Learning resource Center buildings, the north and south quads, and campus walkways and urban trails. During all terrain walking, the participant will be attended by research personnel that will monitor subject safety.

Tipo de estudo

Intervencional

Inscrição (Estimado)

20

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Estados Unidos
    • Arizona
      • Flagstaff, Arizona, Estados Unidos, 86001
        • Northern Arizona University
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Descrição

Inclusion Criteria:

  • Individuals age 18 to 85 with or without lower-limb amputation
  • Able to understand and follow simple directions in English based on ability to provide verbal consent
  • Able to walk at least 30 feet with or without a walking aid
  • Able to safely fit into a device configuration and tolerate assistance
  • Individuals with lower-limb amputation must receive physician approval to participate in the study.

Exclusion Criteria:

  • Any neurological, musculoskeletal (other than lower-limb amputation) or cardiorespiratory injury, health condition (including pregnancy), or diagnosis that would affect the ability to walk as directed for short periods of time.
  • Participant or caregiver report that the perspective participant's physician has recommended that they not engage in moderate intensity walking exercise.
  • Subject mass greater than the engineered limit of the device (90 kg or 198 lbs) Note: No exclusions will be made on the basis of race, gender or ethnic background.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Experimental Group

Trials will take place over-ground and/or on a treadmill. Participants will ambulate for up to 40 minutes. Frequent breaks will be provided between trials and conditions to avoid fatigue and a maximum of 15 minutes of continuous ambulation will take place between breaks. When deemed necessary by the research staff or participant, crutches, canes, walkers, an overhead support system, or other ambulation or safety aid will be used to minimize the risk of a severe fall.

List of ambulation activities will include no more than

  1. Walking at a mild incline/decline (0°-15°) on treadmill or over-ground
  2. Ascending or descending stairs
  3. Stand to sit and sit to stand transitions
  4. All terrain walking over ground
  5. Turning
  6. Any combination of the above-mentioned activities

The above activities will be performed with the passive prosthesis and the motorized prosthesis in the "off", "transparent", and "powered" configurations.
Dispositivo: Passive prosthesis
The participant will perform the study protocol with their "take home" prosthesis and/or another suitable passive prosthesis.
Outros nomes:
  • ao controle
  • linha de base
  • take home prosthesis
Dispositivo: Motorized prosthesis
The motorized prosthesis is an experimental device. The device is constructed from plastic and metal. It has motors, sensors, and electronic systems to control the prosthesis to mimic the behavior of a biological joint. The device is determined non-significant risk by the sponsor's Institutional Review Board.
Outros nomes:
  • powered prosthesis

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Joint position
Prazo: Assessment will be taken on Day 1 (Intervention 1), Day 2 (Intervention 2 - condition 1), Day 3 (Intervention 2 - condition 2), and Day 4 (Intervention 2 - condition 3)
Motion capture measurements will be taken to calculate joint position (degrees) of the ankle, knee, hip, and torso. Participant measurements will be averaged per condition to generate a participant average. Participant averages will be pooled to determine an average per condition.
Assessment will be taken on Day 1 (Intervention 1), Day 2 (Intervention 2 - condition 1), Day 3 (Intervention 2 - condition 2), and Day 4 (Intervention 2 - condition 3)
Joint Velocity
Prazo: Assessment will be taken on Day 1 (Intervention 1), Day 2 (Intervention 2 - condition 1), Day 3 (Intervention 2 - condition 2), and Day 4 (Intervention 2 - condition 3)
Motion capture will be used to record joint velocity (deg/s) of the ankle, knee, hip, and torso. Participant measurements will be averaged per condition to generate a participant average. Participant averages will be pooled to determine an average per condition.
Assessment will be taken on Day 1 (Intervention 1), Day 2 (Intervention 2 - condition 1), Day 3 (Intervention 2 - condition 2), and Day 4 (Intervention 2 - condition 3)
Ground reaction force
Prazo: Assessment will be taken on Day 1 (Intervention 1), Day 2 (Intervention 2 - condition 1), Day 3 (Intervention 2 - condition 2), and Day 4 (Intervention 2 - condition 3)
The force a participant exerts on the ground (Newtons) will be measured using a force plate. Participant measurements will be averaged per condition to generate a participant average. Participant averages will be pooled to determine an average per condition.
Assessment will be taken on Day 1 (Intervention 1), Day 2 (Intervention 2 - condition 1), Day 3 (Intervention 2 - condition 2), and Day 4 (Intervention 2 - condition 3)
Muscle Electric Potential
Prazo: Assessment will be taken on Day 1 (Intervention 1), Day 2 (Intervention 2 - condition 1), Day 3 (Intervention 2 - condition 2), and Day 4 (Intervention 2 - condition 3)
Muscle electric potential will be measured using skin mounted electrodes (surface electromyography) and reported in volts. Participant measurements will be averaged per condition to generate a participant average. Participant averages will be pooled to determine an average per condition.
Assessment will be taken on Day 1 (Intervention 1), Day 2 (Intervention 2 - condition 1), Day 3 (Intervention 2 - condition 2), and Day 4 (Intervention 2 - condition 3)
Gas uptake and exchange
Prazo: Assessment will be taken on Day 1 (Intervention 1), Day 2 (Intervention 2 - condition 1), Day 3 (Intervention 2 - condition 2), and Day 4 (Intervention 2 - condition 3)
Oxygen consumption and CO2 production will be measured in L/s. Participant measurements will be averaged per condition to generate a participant average. Participant averages will be pooled to determine an average per condition.
Assessment will be taken on Day 1 (Intervention 1), Day 2 (Intervention 2 - condition 1), Day 3 (Intervention 2 - condition 2), and Day 4 (Intervention 2 - condition 3)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
User Perception
Prazo: Assessment will be taken on Day 1 (Intervention 1), Day 2 (Intervention 2 - condition 1), Day 3 (Intervention 2 - condition 2), and Day 4 (Intervention 2 - condition 3)
User perception of the device will be assessed using NASA TLX survey. Participants will assess the device on a scale of 1-10 based on a questionnaire. Participant measurements will be averaged per condition to generate a participant average. Participant averages will be pooled to determine an average per condition.
Assessment will be taken on Day 1 (Intervention 1), Day 2 (Intervention 2 - condition 1), Day 3 (Intervention 2 - condition 2), and Day 4 (Intervention 2 - condition 3)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Northern Arizona University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

16 de abril de 2026

Conclusão Primária (Estimado)

15 de março de 2029

Conclusão do estudo (Estimado)

15 de março de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

4 de março de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

7 de maio de 2026

Primeira postagem (Real)

13 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

13 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

7 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 2403974-1

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Descrição do plano IPD

Uncertain if will publish in ICMJE journal

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Sim

produto fabricado e exportado dos EUA

Não

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