Clinical trial NCT03107728: The IM ABLE Study: A Study of Warriors & Veterans Following Neuromusculoskeletal Injury of the Lower Limb
Official title: The IM ABLE Study: A Cross-Sector, Multisite Initiative to Advance Care for Warriors and Veterans Following Neuromusculoskeletal Injury of the Lower Limb
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Limb Salvage
Braces
Lower Extremity
Keywords: orthotics
high-energy lower extremity trauma
physical therapy
bracing
functional performance
performance assessment
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: James A. Haley Veterans Administration Hospital
name: VA New York Harbor Healthcare System
name: Hanger Clinic: Prosthetics & Orthotics
First posted: 2017-04-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Mobility
timeFrame: Mobility will be assessed at Week 2 and Week 4
measure: Change in Ambulatory Function
timeFrame: Ambulatory Function will be assessed at week 2 and week 4.
Secondary outcomes:
measure: Perceived Function
timeFrame: At week 2 and week 4
measure: Pain
timeFrame: At week 2 and week 4
measure: Safety will be measured with the Activities Balance Confidence Scale
timeFrame: At week 2 and week 4
Other outcomes:
Locations:
city: New York
country: United States
facility: New York VA
state: New York
city: Houston
country: United States
facility: Hanger, Inc
state: Texas
Study officials:
References: