PRIORITI-MTF Study- Testing Patient Response to the IDEO

Major Extremity Trauma Research Consortium

Status: Completed

Conditions: Leg Injuries; Trauma

Treatments: Device: IDEO brace

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02158884

W81XWH-12-2-0032

Details and patient eligibility

About

The goal of the PRIORITI-MTF study is to help determine whether a new type of custom designed brace, called the IDEO ™ along with a physical therapy program, called Return to Run, improves physical function. This brace was developed for wounded warriors who wanted to return to an active lifestyle.

The primary objective of this study is to examine the benefits (and cost-benefits) of an integrated orthotic and rehabilitation program that incorporates the Intrepid Dynamic Exoskeletal Orthosis (IDEO) and the Return to Run (RTR) physical therapy regimen, but designed for scalability in the broader military environment (i.e. beyond San Antonio Military Medical Center where the program was developed)

Enrollment: 91 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Ages 18-60

2. Currently two or more years out from a traumatic unilateral lower extremity injury at or below the knee

3. Healed fractures and able to fully weight bear

4. Evidence of either:

   • Weakness of ankle dorsiflexors and /or plantarflexors resulting from leg injury (defined as less than 4 out of 5 on manual muscle test)
   • Limited ankle dorsiflexion (< 10 degrees) and /or limited ankle plantarflexion (< 20 degrees) resulting from leg injury
   • Mechanical pain with loading to hindfoot/midfoot (>= 50 mm on a 0-100 mm visual analogue scale assessing average daily pain)
   • Ankle or Hindfoot fusion or candidate for ankle or hindfoot fusion
   • Candidate for amputation secondary to ankle/foot impairment

Exclusion criteria

1. Ankle plantarflexion or dorsiflexion weakness as a result of spinal cord injury or central nervous system pathology.
2. Non-ambulatory
3. Surgery on study limb anticipated in next 6 months
4. Medical or psychological conditions that would preclude functional testing (ex. severe traumatic brain injury, stroke, renal failure, heart disease, severe anemia)
5. Neurologic, musculoskeletal or other conditions affecting contralateral extremity preventing the study of a healthy control limb
6. Unable or unwilling to participate in two 4-week PT programs
7. Pregnancy
8. Non-English speaking

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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91 participants in 1 patient group

IDEO brace

Other group

Description:

IDEO brace

Treatment:

Device: IDEO brace