Braces, Limb Salvage, Lower Extremity
Conditions
Keywords
orthotics, high-energy lower extremity trauma, physical therapy, bracing, functional performance, performance assessment
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.
Interventions
DEVICEAdvanced orthotic brace
Participants will use an advanced exoskeletal orthosis.
DEVICEConventional orthotic brace
Participants will use the standard of care orthosis
Sponsors
James A. Haley Veterans Administration Hospital
VA New York Harbor Healthcare System
Hanger Clinic: Prosthetics & Orthotics
University of South Florida
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mobility | Mobility will be assessed at Week 2 and Week 4 | 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. |
| Change in Ambulatory Function | Ambulatory Function will be assessed at week 2 and week 4. | The 2 Minute Walk Test will be used to assess ambulatory function |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Function | At week 2 and week 4 | Perceived Function will be assessed via the EQ-5D (EuroQol 5D), a five item ordinally scaled patient self-report. |
| Pain | At week 2 and week 4 | Pain rating scale 0-10 |
| Safety will be measured with the Activities Balance Confidence Scale | At week 2 and week 4 | Safety will be measured with the Activities Balance Confidence Scale, a 16 item self-report measure of perceived balance confidence |
Countries
United States
Outcome results
None listed