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

20 juillet 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

75

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Stephanie L Carey, PhD
  • Numéro de téléphone: 813-974-5765
  • E-mail: scarey3@usf.edu

Lieux d'étude

  • États-Unis
    • Florida
      • Tampa, Florida, États-Unis, 33620
        • Recrutement
        • University of South Florida, Rehabilitation Robotics & Prosthetics Testbed (RRT)
        • Contact:
          • Stephanie L Carey, PhD
          • Numéro de téléphone: 813-974-5765
          • E-mail: scarey3@usf.edu
        • Chercheur principal:
          • Stephanie L Carey, PhD
      • Tampa, Florida, États-Unis, 33637
        • Recrutement
        • James A. Haley VA Center of Innovation of Disability & Rehab Research
        • Contact:
        • Chercheur principal:
          • Sam Phillips
    • New York
      • New York, New York, États-Unis, 10010
        • Recrutement
        • VA New York Harbor Healthcare System
        • Chercheur principal:
          • Jason Maikos, PhD
        • Contact:
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Conventional Ankle Foot Orthosis (AFO)
Limited function; thermoplastic or thermoset material
Dispositif: 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.
Autres noms:
  • Conventional AFO
  • Traditional AFO
Comparateur actif: Advanced Ankle Foot Orthosis (AFO)
Return stored energy; laminated; may include posterior struts; higher activity
Dispositif: 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.
Autres noms:
  • Advanced AFO

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Timed Up & Go
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Preference
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of South Florida

Collaborateurs

VA New York Harbor Healthcare System
Tampa VA Healthcare System

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

31 juillet 2026

Achèvement primaire (Estimé)

10 janvier 2029

Achèvement de l'étude (Estimé)

31 janvier 2029

Dates d'inscription aux études

Première soumission

26 mars 2026

Première soumission répondant aux critères de contrôle qualité

20 juillet 2026

Première publication (Réel)

23 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

23 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

20 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • STUDY009017
  • HT9425-25-1-0478 (Autre subvention/numéro de financement: US Army Medical Research & Material Command)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Oui

produit fabriqué et exporté des États-Unis.

Oui

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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