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

20 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

75

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Stephanie L Carey, PhD
  • Numero di telefono: 813-974-5765
  • Email: scarey3@usf.edu

Luoghi di studio

  • Stati Uniti
    • Florida
      • Tampa, Florida, Stati Uniti, 33620
        • Reclutamento
        • University of South Florida, Rehabilitation Robotics & Prosthetics Testbed (RRT)
        • Contatto:
          • Stephanie L Carey, PhD
          • Numero di telefono: 813-974-5765
          • Email: scarey3@usf.edu
        • Investigatore principale:
          • Stephanie L Carey, PhD
      • Tampa, Florida, Stati Uniti, 33637
        • Reclutamento
        • James A. Haley VA Center of Innovation of Disability & Rehab Research
        • Contatto:
        • Investigatore principale:
          • Sam Phillips
    • New York
      • New York, New York, Stati Uniti, 10010
        • Reclutamento
        • VA New York Harbor Healthcare System
        • Investigatore principale:
          • Jason Maikos, PhD
        • Contatto:
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Altri nomi:
  • Conventional AFO
  • Traditional AFO
Comparatore attivo: 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.
Altri nomi:
  • Advanced AFO

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Timed Up & Go
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Preference
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of South Florida

Collaboratori

VA New York Harbor Healthcare System
Tampa VA Healthcare System

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

31 luglio 2026

Completamento primario (Stimato)

10 gennaio 2029

Completamento dello studio (Stimato)

31 gennaio 2029

Date di iscrizione allo studio

Primo inviato

26 marzo 2026

Primo inviato che soddisfa i criteri di controllo qualità

20 luglio 2026

Primo Inserito (Effettivo)

23 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

23 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • STUDY009017
  • HT9425-25-1-0478 (Altro numero di sovvenzione/finanziamento: US Army Medical Research & Material Command)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

prodotto fabbricato ed esportato dagli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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