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

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.

Study Overview

• Status: Unknown
• Conditions: Braces; Limb Salvage; Lower Extremity
• Intervention / Treatment: Device: Advanced orthotic brace; Device: Conventional orthotic brace

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10010
      • Recruiting
      • New York VA
      • Contact: Jason Maikos, PhD; Phone Number: 7482 212-686-7500; Email: jason.maikos@va.gov
  • Texas
    • Houston, Texas, United States, 77025
      • Recruiting
      • Hanger, Inc
      • Contact: Shane Wurdeman, PhD; Phone Number: 402-290-8051; Email: swurdeman@hanger.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Advanced orthotic brace	Device: Advanced orthotic brace; Participants will use an advanced exoskeletal orthosis.
Active Comparator: Conventional orthotic brace	Device: Conventional orthotic brace; Participants will use the standard of care orthosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Pain	Pain rating scale 0-10	At week 2 and week 4
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2018
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: March 29, 2017
• First Submitted That Met QC Criteria: April 10, 2017
• First Posted (Actual): April 11, 2017

Study Record Updates

• Last Update Posted (Actual): March 20, 2019
• Last Update Submitted That Met QC Criteria: March 18, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: functional performance; physical therapy; bracing; orthotics; high-energy lower extremity trauma; performance assessment
• Other Study ID Numbers: Pro00026645; W81XWH-16-1-0738 (Other Grant/Funding Number: USAMRAA)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No