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

University of South Florida120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

120

Conditions

Limb Salvage Braces Lower Extremity

Interventions

Advanced orthotic braceDEVICE

Participants will use an advanced exoskeletal orthosis.

Conventional orthotic braceDEVICE

Participants will use the standard of care orthosis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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)

Locations (2)

New York VA

New York, New York, United States

RECRUITING

Hanger, Inc

Houston, Texas, United States

RECRUITING

Outcomes

Primary Outcomes

Change in Mobility

Mobility will be assessed with the Timed Up \& Go test. subjects are timed while they rise from a chair, walk 3m, turn around, return to the chair and sit down again. Patients are usually permitted to use a walking aid, but not to use physical assistance.

Time frame: Mobility will be assessed at Week 2 and Week 4

Change in Ambulatory Function

The 2 Minute Walk Test will be used to assess ambulatory function

Time frame: Ambulatory Function will be assessed at week 2 and week 4.

Secondary Outcomes

Perceived Function

Perceived Function will be assessed via the EQ-5D (EuroQol 5D), a five item ordinally scaled patient self-report.

Time frame: At week 2 and week 4

Pain

Pain rating scale 0-10

Time frame: At week 2 and week 4

Safety will be measured with the Activities Balance Confidence Scale

Safety will be measured with the Activities Balance Confidence Scale, a 16 item self-report measure of perceived balance confidence

Time frame: At week 2 and week 4

Data from ClinicalTrials.gov

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