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

Not Applicable

• Conditions: Braces; Lower Extremity; Limb Salvage
• Interventions: Device: Advanced orthotic brace; Device: Conventional orthotic brace

• Registration Number: NCT03107728
• Lead Sponsor: University of South Florida

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.

Study Timeline

• Study First Submitted: 2017-03-29
• Study First Submitted QC: 2017-04-10
• Study First Posted: 2017-04-11
• Study Start: 2018-02-22
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-18
• Last Update Posted: 2019-03-20
• Primary Completion: 2019-06
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Advanced orthotic brace	Advanced orthotic brace	-
Conventional orthotic brace	Conventional orthotic brace	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

New York VA; 🇺🇸 New York, New York, United States

Hanger, Inc; 🇺🇸 Houston, Texas, United States