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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
Randomized cross over with long term observational follow up. Conventional AFO and Advanced AFO. Assess long-term (1 year) patient-reported outcomes of advanced and conventional AFO use in individuals with lower extremity trauma.
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)
Masking Description
Statistician

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Conventional Ankle Foot Orthosis (AFO) 		Limited function; thermoplastic or thermoset material
  • Device: 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.
    Other names:
    • Conventional AFO
    • Traditional AFO
Active Comparator
Advanced Ankle Foot Orthosis (AFO) 		Return stored energy; laminated; may include posterior struts; higher activity
  • Device: 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.
    Other names:
    • Advanced AFO

Recruiting Locations

University of South Florida, Rehabilitation Robotics & Prosthetics Testbed (RRT)
Tampa, Florida 33620
Contact:
Stephanie L Carey, PhD
813-974-5765
scarey3@usf.edu

James A. Haley VA Center of Innovation of Disability & Rehab Research
Tampa, Florida 33637
Contact:
Sam Phillips, PhD
813-558-3995
Samuel.Phillips@va.gov

VA New York Harbor Healthcare System
New York, New York 10010
Contact:
Jason Maikos, PhD
212-686-7500
jason.maikos@va.gov

More Details

Status
Recruiting
Sponsor
University of South Florida

Study Contact

Stephanie L Carey, PhD
813-974-5765
scarey3@usf.edu

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.