NCT03107728

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

The IM ABLE Study: A Cross-Sector, Multisite Initiative to Advance Care for Warriors and Veterans Following Neuromusculoskeletal Injury of the Lower Limb

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University of South Florida · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Limb Salvage
• Braces
• Lower Extremity

Interventions

Type	Name	Description
DEVICE	Advanced orthotic brace	Participants will use an advanced exoskeletal orthosis.
DEVICE	Conventional orthotic brace	Participants will use the standard of care orthosis

Timeline

• Start date: 2018-02-22
• Primary completion: 2019-06-01
• Completion: 2019-09-01
• First posted: 2017-04-11
• Last updated: 2019-03-20

Locations

2 sites across 1 country: United States