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



Status:Recruiting
Healthy:No
Age Range:18 - 65
Updated:3/22/2019
Start Date:February 22, 2018
End Date:September 2019

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The IM ABLE Study: A Cross-Sector, Multisite Initiative to Advance Care for Warriors and Veterans Following Neuromusculoskeletal Injury of the Lower Limb

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.

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.

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 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)
We found this trial at
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Houston, Texas 77025
Phone: 402-290-8051
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New York, New York 10010
Phone: 212-686-7500
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New York, NY
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