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

Lower Extremity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03107728
• Other study ID #: Pro00026645
• Secondary ID: W81XWH-16-1-0738
• Status: Recruiting
• Phase: N/A
• Start date: February 22, 2018
• Est. completion date: September 2019

Study information

• Verified date: March 2019
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Braces
• Limb Salvage
• Lower Extremity

Intervention

Device:
• Advanced orthotic brace
Participants will use an advanced exoskeletal orthosis.
• Conventional orthotic brace
Participants will use the standard of care orthosis

Locations

Country	Name	City	State
United States	Hanger, Inc	Houston	Texas
United States	New York VA	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
University of South Florida	Hanger Clinic: Prosthetics & Orthotics, James A. Haley Veterans Administration Hospital, VA New York Harbor Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Pain	Pain rating scale 0-10	At week 2 and week 4
Secondary	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