N/A
Completed N=91
PRIORITI-MTF Study- Testing Patient Response to the IDEO
Leg Injuries · Trauma
Source: ClinicalTrials.gov NCT02158884 ↗
Enrolled (actual)
91
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcomePrimary: Four Square Step Test — 8.0 seconds
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)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Four Square Step Test |
8.0 | — |
| PRIMARY Baseline Illinois Agility Test |
31.5 | — |
| PRIMARY Sit to Stand Test |
7.9 | — |
| PRIMARY Timed Stair Assent |
6.2 | — |
| PRIMARY Shuttle Run |
2.5 | — |
| PRIMARY Short Musculoskeletal Function Assessment (SMFA) Overall Dysfunction (Items 1-34) |
28.6 | — |
| PRIMARY Short Musculoskeletal Function Assessment (SMFA) - Mobility |
28.9 | — |
| PRIMARY The Short Musculoskeletal Function Assessment (SMFA) - Daily Activities |
31.0 | — |
| PRIMARY Short Musculoskeletal Function Assessment (SMFA) - Hand and Arm Function |
3.0 | — |
| PRIMARY Short Musculoskeletal Function Assessment (SMFA) - Emotional Status |
39.2 | — |
| PRIMARY Veterans RAND 12 Item Health Survey - Physical Component Summary |
32.9 | — |
| PRIMARY Veterans RAND 12 Item Health Survey (VR-12) - Mental Health Component Summary |
53.2 | — |
| PRIMARY 4 Step Square Test |
6.1 | — |
| PRIMARY Illinois Agility Test |
22.3 | — |
| PRIMARY Sit to Stand Test |
7.9 | — |
| PRIMARY Timed Stair Assent Test |
4.2 | — |
| PRIMARY Short Musculoskeletal Function Assessment (SMFA) - Overall Dysfunction |
23.1 | — |
| PRIMARY Short Musculoskeletal Function Assessment (SMFA) - Mobility |
28.9 | — |
| PRIMARY Short Musculoskeletal Function Assessment (SMFA) - Daily Activities |
23.1 | — |
| PRIMARY Short Musculoskeletal Function Assessment (SMFA) - Hand and Arm Function |
3.0 | — |
| PRIMARY Short Musculoskeletal Function Assessment (SMFA) - Emotional Status |
39.2 | — |
| PRIMARY Veterans RAND 12 Item Health Survey (VR-12) - Physical Component Summary (PCS) |
40.1 | — |
| PRIMARY Veterans RAND 12 Item Health Survey (VR-12) Mental Health Component Summary (MCS) |
52.6 | — |
| PRIMARY Short Musculoskeletal Function Assessment (SMFA) - Overall Dysfunction |
23.1 | — |
| PRIMARY Short Musculoskeletal Function Assessment (SMFA) - Mobility |
28.9 | — |
| PRIMARY Short Musculoskeletal Function Assessment (SMFA) - Daily Activities |
23.1 | — |
| PRIMARY Short Musculoskeletal Function Assessment (SMFA) - Hand and Arm Function |
3.0 | — |
| PRIMARY Short Musculoskeletal Function Assessment (SMFA) - Emotional Status |
39.2 | — |
| PRIMARY Veterans RAND 12 Item Health Survey (VR-12) - Physical Component Summary (PCS) |
40.1 | — |
| PRIMARY Veterans RAND 12 Item Health Survey (VR-12) - Mental Health Component Summary (MCS) |
53.5 | — |
Eligibility Criteria
Inclusion Criteria
- Ages 18-60
- Currently two or more years out from a traumatic unilateral lower extremity injury at or below the knee
- Healed fractures and able to fully weight bear
- 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 ( = 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
- Ankle plantarflexion or dorsiflexion weakness as a result of spinal cord injury or central nervous system pathology.
- Non-ambulatory
- Surgery on study limb anticipated in next 6 months
- Medical or psychological conditions that would preclude functional testing (ex. severe traumatic brain injury, stroke, renal failure, heart disease, severe anemia)
- Neurologic, musculoskeletal or other conditions affecting contralateral extremity preventing the study of a healthy control limb
- Unable or unwilling to participate in two 4-week PT programs
- Pregnancy
- Non-English speaking
Data sourced from ClinicalTrials.gov (NCT02158884). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.