Clinical trial NCT02158884: PRIORITI-MTF Study- Testing Patient Response to the IDEO
Official title: Patient Response to an Integrated Orthotic and Rehabilitation Initiative for Traumatic Injuries for the Military Treatment Facilities (PRIORITI-MTF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leg Injuries
Trauma
Keywords: Major extremity trauma
wounded warriors
IDEO
return to run
Lead sponsor: Major Extremity Trauma Research Consortium
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2014-06-09
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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)


Eligibility criteria: 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

Primary outcomes:
measure: Four Square Step Test
timeFrame: Baseline
measure: Baseline Illinois Agility Test
timeFrame: Baseline
measure: Sit to Stand Test
timeFrame: Baseline
measure: Timed Stair Assent
timeFrame: Baseline
measure: Shuttle Run
timeFrame: Baseline
measure: Short Musculoskeletal Function Assessment (SMFA) Overall Dysfunction (Items 1-34)
timeFrame: Baseline
measure: Short Musculoskeletal Function Assessment (SMFA) - Mobility
timeFrame: Baseline
measure: The Short Musculoskeletal Function Assessment (SMFA) - Daily Activities
timeFrame: Baseline
measure: Short Musculoskeletal Function Assessment (SMFA) - Hand and Arm Function
timeFrame: Baseline
measure: Short Musculoskeletal Function Assessment (SMFA) - Emotional Status
timeFrame: Baseline
measure: Veterans RAND 12 Item Health Survey - Physical Component Summary
timeFrame: Baseline
measure: Veterans RAND 12 Item Health Survey (VR-12) - Mental Health Component Summary
timeFrame: Baseline
measure: 4 Step Square Test
timeFrame: Post intervention (approx 4 weeks post IDEO fit)
measure: Illinois Agility Test
timeFrame: Post intervention (approx 4 weeks post IDEO fit)
measure: Sit to Stand Test
timeFrame: Post intervention (approx 4 weeks post IDEO fit)
measure: Timed Stair Assent Test
timeFrame: Post intervention (approx 4 weeks post IDEO fit)
measure: Short Musculoskeletal Function Assessment (SMFA) - Overall Dysfunction
timeFrame: 6 months
measure: Short Musculoskeletal Function Assessment (SMFA) - Mobility
timeFrame: 6 months
measure: Short Musculoskeletal Function Assessment (SMFA) - Daily Activities
timeFrame: 6 months
measure: Short Musculoskeletal Function Assessment (SMFA) - Hand and Arm Function
timeFrame: 6 months
measure: Short Musculoskeletal Function Assessment (SMFA) - Emotional Status
timeFrame: 6 months
measure: Veterans RAND 12 Item Health Survey (VR-12) - Physical Component Summary (PCS)
timeFrame: 6 months
measure: Veterans RAND 12 Item Health Survey (VR-12) Mental Health Component Summary (MCS)
timeFrame: 6 months
measure: Short Musculoskeletal Function Assessment (SMFA) - Overall Dysfunction
timeFrame: 12 months
measure: Short Musculoskeletal Function Assessment (SMFA) - Mobility
timeFrame: 12 months
measure: Short Musculoskeletal Function Assessment (SMFA) - Daily Activities
timeFrame: 12 months
measure: Short Musculoskeletal Function Assessment (SMFA) - Hand and Arm Function
timeFrame: 12 months
measure: Short Musculoskeletal Function Assessment (SMFA) - Emotional Status
timeFrame: 12 months
measure: Veterans RAND 12 Item Health Survey (VR-12) - Physical Component Summary (PCS)
timeFrame: 12 months
measure: Veterans RAND 12 Item Health Survey (VR-12) - Mental Health Component Summary (MCS)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: San Antonio
country: United States
facility: San Antonio Center for the Intrepid
state: Texas
Study officials:
References: