PRIORITI-MTF Study- Testing Patient Response to the IDEO

Status:	Completed
Conditions:	Hospital
Therapuetic Areas:	Other
Healthy:	No
Age Range:	18 - 60
Updated:	11/8/2018
Start Date:	June 2014
End Date:	April 2018

Patient Response to an Integrated Orthotic and Rehabilitation Initiative for Traumatic Injuries for the Military Treatment Facilities (PRIORITI-MTF)

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)

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

We found this trial at

sites

Walter Reed National Military Medical Center

8901 Rockville Pike
Bethesda, Maryland 20889

(301) 295-4000