The IM ABLE Study: A Study of Warriors & Veterans Following Neuromusculoskeletal Injury of the Lower Limb

Last updated: March 18, 2019
Sponsor: University of South Florida
Overall Status: Active - Recruiting

Phase

N/A

Condition

Limb Preservation And Amputation

Treatment

N/A

Clinical Study ID

NCT03107728
Pro00026645
W81XWH-16-1-0738
  • Ages 18-65
  • All Genders

Study Summary

The purpose of the IM ABLE(Injuries Managed with Advanced Bracing for Lower Extremities) study is to determine if advanced (ADV) ankle foot orthoses (AFOs) will enable users to achieve greater levels of physical and self-reported function compared with conventional (CONV) AFOs for those ambulating at or above the independent community level of ambulation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Lower extremity injury of any etiology requiring use of an AFO

  2. Male or Female, of any ethnicity

  3. 18-65 yrs of age

  4. 100-275 lbs

  5. ≥ 1 yr. of orthotic experience

Exclusion

Exclusion Criteria:

  1. Body weight <100 or >275 lbs

  2. Does not speak English or Spanish

  3. Known cognitive impairment (i.e. Diagnoses such as Traumatic Brain Injury, Dementia)

Study Design

Total Participants: 120
Study Start date:
February 22, 2018
Estimated Completion Date:
September 30, 2019

Study Description

There were approximately 20,000 extremity trauma cases associated with the wars in Iraq and Afghanistan. Many of these individuals have experienced multiple limb-sparing surgeries and orthotic utilization. Many continue functioning with use of their orthosis while others may seek delayed amputation. It is unclear if limb salvage or amputation is more advantageous functionally or preferred following lower extremity(LE) trauma. The IDEO (Intrepid Dynamic Exoskeletal Orthosis) was developed to assist in maintaining high functional performance in patients who have experienced high energy lower extremity trauma (HELET) and limb salvage surgeries primarily effecting the LE below the level of the knee joint. The IDEO represents one "advanced" orthotic option for a traumatized and surgically spared limb however there are other "advanced" orthotic options. Problematically, few studies have reported outcomes associated with these devices. In the few studies available, sample sizes are small which greatly reduces generalizability of study findings. The purpose of the IM ABLE study is to determine if advanced (ADV) ankle foot orthoses (AFOs) will enable users to achieve greater levels of physical and self-reported function compared with conventional (CONV) AFOs for those ambulating at or above the independent community level of ambulation.

Connect with a study center

  • New York VA

    New York, New York 10010
    United States

    Active - Recruiting

  • Hanger, Inc

    Houston, Texas 77025
    United States

    Active - Recruiting

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