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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Limb Salvage, Braces, Lower Extremity

Intervention / Treatment
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* Device: Advanced orthotic brace
* Device: Conventional orthotic brace


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Lower extremity injury of any etiology requiring use of an AFO Male or Female, of any ethnicity 18-65 yrs of age 100-275 lbs ≥ 1 yr. of orthotic experience Exclusion Criteria: Body weight <100 or >275 lbs Does not speak English or Spanish Known cognitive impairment (i.e. Diagnoses such as Traumatic Brain Injury, Dementia)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Advanced orthotic brace<br> | Device: Advanced orthotic brace<br>* Participants will use an advanced exoskeletal orthosis.<br>|
| Active Comparator: Conventional orthotic brace<br> | Device: Conventional orthotic brace<br>* Participants will use the standard of care orthosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | Ambulatory Function will be assessed at week 2 and week 4. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Function | Perceived Function will be assessed via the EQ-5D (EuroQol 5D), a five item ordinally scaled patient self-report. | At week 2 and week 4 | 
| Pain | Pain rating scale 0-10 | 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 | At week 2 and week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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orthotics, high-energy lower extremity trauma, physical therapy, bracing, functional performance, performance assessment