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

University of South Florida

Status: Unknown

Conditions: Lower Extremity; Braces; Limb Salvage

Treatments: Device: Conventional orthotic brace; Device: Advanced orthotic brace

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03107728

Pro00026645

W81XWH-16-1-0738 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Advanced orthotic brace

Experimental group

Treatment:

Device: Advanced orthotic brace

Conventional orthotic brace

Active Comparator group

Treatment:

Device: Conventional orthotic brace