Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

IM ABLE 2: Injuries Managed With Advanced Bracing for Lower Extremities (IM ABLE 2)

20 de julho de 2026 atualizado por: University of South Florida

The IM ABLE 2 Study: Long Term Outcomes to Advance Care for Warriors and Veterans Using Advanced Ankle Foot Orthoses

The purpose of the study is to test different categories of ankle foot orthoses (AFOs) with patients who have had lower limb salvage, reconstruction or other problems impacting limb function.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

The purpose of the study is to test different categories of ankle foot orthoses (AFOs) with patients who have had lower limb salvage, reconstruction or other problems impacting limb function. Some lower limb AFO users will decide later to amputate the affected limb to escape pain and repeated surgery requiring them to use a prosthesis instead. Benefits may include reduced pain and more function from a prosthesis.

This research will allow physicians, physical therapists, orthotists, and researchers to determine what modifications can be made to AFOs to make them more comfortable and usable. Over the course of a year, subjects will test both AFO types; a conventional (standard) AFO and an advanced (energy storing and return) AFO, in a battery of physical tests, community use, and surveys to gain a better understanding of the pros and cons of each.

Subjects will be recruited to participate in research for approximately 18 months. During the first six weeks (up to three weeks on each type of AFO), subjects will be provided with an AFO and given training on how to correctly use and maintain it, to ensure optimal use. Over the following 12 months, there will be monthly assessments including questionnaires, activity monitor uploads, device failures, and interviews to gather information on the subject's experience with AFO use.

Tipo de estudo

Intervencional

Inscrição (Estimado)

75

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

  • Nome: Stephanie L Carey, PhD
  • Número de telefone: 813-974-5765
  • E-mail: scarey3@usf.edu

Locais de estudo

  • Estados Unidos
    • Florida
      • Tampa, Florida, Estados Unidos, 33620
        • Recrutamento
        • University of South Florida, Rehabilitation Robotics & Prosthetics Testbed (RRT)
        • Contato:
          • Stephanie L Carey, PhD
          • Número de telefone: 813-974-5765
          • E-mail: scarey3@usf.edu
        • Investigador principal:
          • Stephanie L Carey, PhD
      • Tampa, Florida, Estados Unidos, 33637
        • Recrutamento
        • James A. Haley VA Center of Innovation of Disability & Rehab Research
        • Contato:
        • Investigador principal:
          • Sam Phillips
    • New York
      • New York, New York, Estados Unidos, 10010
        • Recrutamento
        • VA New York Harbor Healthcare System
        • Investigador principal:
          • Jason Maikos, PhD
        • Contato:
        • 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

Não

Descrição

Inclusion Criteria:

  • Lower extremity injury of any etiology requiring current use of an AFO
  • Age 18-80 years
  • 100-275 lbs
  • Greater than 1 month of AFO experience
  • Use of an AFO for activities of daily living
  • English or Spanish speaking
  • Able to comply with study procedures

Exclusion Criteria:

  • Body mass less than 100 or greater than 275 lbs.
  • Over 80 years of age
  • Known cognitive impairment (e.g. diagnoses such as moderate/severe traumatic brain injury, dementia)
  • Inability to comply with instructions.
  • Pregnancy
  • Medical conditions that would preclude safe involvement
  • Unable to provide written informed consent.

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: Cuidados de suporte
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição cruzada
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Conventional Ankle Foot Orthosis (AFO)
Limited function; thermoplastic or thermoset material
Dispositivo: Conventional Ankle Foot Orthosis (AFO)
Subjects will be initially fit with the AFO category they do not use on a daily basis to ensure they have both AFO categories for the study. Conventional Ankle Foot Orthoses have been more commonly used in past decades. AFOs within the conventional category generally include designs that will not return stored energy in late stance. These designs may vary in material construction and componentry. For instance, mechanical joints can be incorporated but do not have to be for inclusion in this group. AFOs in this category may be thermoplastic materials or thermoset laminate. The devices may be off-the-shelf or custom molded to the patient.
Outros nomes:
  • Conventional AFO
  • Traditional AFO
Comparador Ativo: Advanced Ankle Foot Orthosis (AFO)
Return stored energy; laminated; may include posterior struts; higher activity
Dispositivo: Advanced Ankle Foot Orthosis (AFO)
Subjects will be initially fit with the AFO category they do not use on a daily basis to ensure they have both AFO categories for the study. These "advanced" AFOs have been developed to offer energy-storing-and-returning (ESR) properties to the user. Advanced Ankle Foot Orthoses include designs that are widely believed to return stored energy in late stance. These designs are laminated and may include posterior struts.
Outros nomes:
  • Advanced AFO

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Timed Up & Go
Prazo: After 3-week accommodation period with device A and after 3-week accommodation period with device B.
The Timed Up& Go (TUG) assesses mobility. In this test, subjects are timed while they rise from a chair, walk 3m, turn around, return to the chair and sit down again. Subjects are usually permitted to use a walking aid, but not to use physical assistance.
After 3-week accommodation period with device A and after 3-week accommodation period with device B.
Two-minute Walk Test
Prazo: After 3-week accommodation period with device A and after 3-week accommodation period with device B.
The Two-minute Walk Test (2MWT) assesses walking ability. Subjects will be asked to walk the greatest distance they can in 2 minutes while walking a 15.2m 'out and back' course until asked to stop. The distance walked will be recorded as will the post-test rate of perceived exertion (6-20 Borg RPE scale).
After 3-week accommodation period with device A and after 3-week accommodation period with device B.
Four-Square-Step-Test
Prazo: After 3-week accommodation period with device A and after 3-week accommodation period with device B.
The Four-Square-Step-Test is a balance and agility test where the patient changes direction quickly while maintaining balance. A 1-inch-high obstacle in the shape of a Maltese cross is placed on the floor. The patient is instructed to begin in the back, left quadrant then to move 1) forward, 2) sideways right, 3) backward, then 4) sideways left, then to move in the reverse direction back to the original square. They move as fast as possible through their movement progression while always keeping one foot on the floor.
After 3-week accommodation period with device A and after 3-week accommodation period with device B.
Activities-Specific Balance Confidence Scale
Prazo: After 3-week accommodation period with device A and after 3-week accommodation period with device B.
The Activities-Specific Balance Confidence Scale (ABC Scale) is a 16-item self-report tool that measures an individual's confidence in performing daily activities without losing balance or feeling unsteady. Participants rate their confidence for each activity on a 0% to 100% scale where 0% indicates no confidence and 100% indicates complete confidence.
After 3-week accommodation period with device A and after 3-week accommodation period with device B.
Patient-Reported Outcomes Measurement Information System (PROMIS)
Prazo: After 3-week accommodation period with device A and after 3-week accommodation period with device B. Monthly for 12 months after accommodation period with device B.
The Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (PROMIS-PI) is a standardized, self-reported tool designed to assess the extent to which pain disrupts a person's daily activities and quality of life. The PROMIS-PI evaluates the impact of pain on social, physical, emotional and cognitive functioning. Responses are rated on a 5-point scale from "never" to "very much" regarding how pain interfered with activities in the past week.
After 3-week accommodation period with device A and after 3-week accommodation period with device B. Monthly for 12 months after accommodation period with device B.
Orthotics and Prosthetics Users' Survey (OPUS)
Prazo: After 3-week accommodation period with device A and after 3-week accommodation period with device B. Monthly for 12 months after accommodation period with device B.
The OPUS is a self-report questionnaire consisting of five modules. The following four modules related to the lower extremity will be used: 1) Lower Extremity Functional Status Measure, 2) Health Related Quality of Life Index, 3) Satisfaction with Devices and 4) Satisfaction with Services. The first two modules are based on a five-point Likert scale and nominal Yes/No scale while the latter two use a four-point Likert scale. Higher scores indicate better outcomes.
After 3-week accommodation period with device A and after 3-week accommodation period with device B. Monthly for 12 months after accommodation period with device B.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Preference
Prazo: Before and after each accommodation and training period. At 12 month follow-up.
Interviews with participants will be used to identify overall preference and device preference for different activities. Interviews will also ask about the specific needs, preferences, challenges, and limitations of using each device.
Before and after each accommodation and training period. At 12 month follow-up.
Activity monitoring
Prazo: Monthly for 12 months after initial two accommodation and training periods
The activity monitors will measure active and sedentary periods of behavior. Specific variables estimated will include - time spent sitting, standing, stepping, time spent in sedentary, light and moderate-to-vigorous intensity activity, time spent in prolonged sitting bouts (e.g., sitting bouts > 30 min, > 60 min etc.), time spent in bouts of moderate-to-vigorous intensity (e.g., > 10 minute bouts, i.e., activity bouts known to improve health), number of steps per day and number of sit-to-stand transitions per sedentary time.
Monthly for 12 months after initial two accommodation and training periods

Colaboradores e Investigadores

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

Patrocinador

University of South Florida

Colaboradores

VA New York Harbor Healthcare System
Tampa VA Healthcare System

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)

31 de julho de 2026

Conclusão Primária (Estimado)

10 de janeiro de 2029

Conclusão do estudo (Estimado)

31 de janeiro de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

26 de março de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

20 de julho de 2026

Primeira postagem (Real)

23 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

23 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

20 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • STUDY009017
  • HT9425-25-1-0478 (Número de outro subsídio/financiamento: US Army Medical Research & Material Command)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

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

Sim

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 .

Se inscrever