Overview

This trial is active, not recruiting.

Conditions leg injuries, trauma
Treatment ideo brace
Sponsor Major Extremity Trauma Research Consortium
Collaborator United States Department of Defense
Start date June 2014
End date December 2016
Trial size 90 participants
Trial identifier NCT02158884, W81XWH-12-2-0032

Summary

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)

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
IDEO brace
ideo brace IDEO
All participants will receive the IDEO brace.

Primary Outcomes

Measure
Change in functional performance
time frame: Change from baseline functional performance at 6 and 12 months

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Official title Patient Response to an Integrated Orthotic and Rehabilitation Initiative for Traumatic Injuries for the Military Treatment Facilities (PRIORITI-MTF)
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Major Extremity Trauma Research Consortium.