PRIORITI-MTF Study- Testing Patient Response to the IDEO

Study Overview
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Brief Summary
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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)

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

Conditions
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Leg Injuries, Trauma

Intervention / Treatment
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* Device: IDEO brace


Participation Criteria
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Eligibility Criteria
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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 (< 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: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: IDEO brace<br>IDEO brace | Device: IDEO brace<br>* All participants will receive the IDEO brace.<br>* Other names: IDEO;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Four Square Step Test | The 4 step square test is an objective measure of agility. It is measured in seconds, with a range of > 0   +∞. Lower values represent better outcomes. (This measure is part of the change in functional performance composite measure calculated using the mean of participant's score across several objective performance measures of agility, strength and power, speed, and postural stability). | Baseline | 
| Baseline Illinois Agility Test | The Illinois Agility test is an objective measure of agility. It is measured in seconds, with a range of > 0   +∞. Lower values represent better outcomes. (The Illinois Agility test is part of the change in functional performance composite measure calculated using the mean of participant's score across several objective performance measures of agility, strength and power, speed, and postural stability) | Baseline | 
| Sit to Stand Test | The Sit to Stand test is an objective measure of strength and power. It is measured in seconds, with a range of > 0   +∞. Lower values represent better outcomes. (The Sit to Stand test is part of the change in functional performance composite measure calculated using the mean of participant's score across several objective performance measures of agility, strength and power, speed, and postural stability)range: > 0   +∞ | Baseline | 
| Timed Stair Assent | The Timed Stair Assent test is an objective measure of strength and power. It is measured in seconds, with a range of > 0   +∞. Lower values represent better outcomes. (The Timed Stair Assent test is part of the change in functional performance composite measure calculated using the mean of participant's score across several objective performance measures of agility, strength and power, speed, and postural stability) | Baseline | 
| Shuttle Run | The Shuttle run test is an objective measure of agility. It is measured in seconds, with a range of > 0   +∞. Higher values represent better outcomes. (The Shuttle run is part of the change in functional performance composite measure calculated using the mean of participant's score across several objective performance measures of agility, strength and power, speed, and postural stability) | Baseline | 
| Short Musculoskeletal Function Assessment (SMFA) Overall Dysfunction (Items 1-34) | The Short Musculoskeletal function Assessment (SMFA) is a participant reported assessment of the impact a musculoskeletal condition on individual function and daily activities. This study used Short Musculoskeletal Function Assessment (SMFA) modules for Overall dysfunction, mobility, daily activities, hand and arm function, and emotional status. Scores range is 0-100. Lower scores indicate better function. Scores are standardized; the formula for standardization is: ((Actual total raw score - lowest possible raw score)/possible raw score range) *100 | Baseline | 
| Short Musculoskeletal Function Assessment (SMFA) - Mobility | The Short Musculoskeletal function Assessment (SMFA) is a participant reported assessment of the impact a musculoskeletal condition on individual function and daily activities. This study used Short Musculoskeletal Function Assessment (SMFA) modules for Overall dysfunction, mobility, daily activities, hand and arm function, and emotional status. Scores range is 0-100. Lower scores indicate better function. Scores are standardized; the formula for standardization is: ((Actual total raw score - lowest possible raw score)/possible raw score range) *100 | Baseline | 
| The Short Musculoskeletal Function Assessment (SMFA) - Daily Activities | The Short Musculoskeletal function Assessment (SMFA) is a participant reported assessment of the impact a musculoskeletal condition on individual function and daily activities. This study used Short Musculoskeletal Function Assessment (SMFA) modules for Overall dysfunction, mobility, daily activities, hand and arm function, and emotional status. Scores range is 0-100. Lower scores indicate better function. Scores are standardized; the formula for standardization is ((Actual total raw score - lowest possible raw score)/possible raw score range) *100 | Baseline | 
| Short Musculoskeletal Function Assessment (SMFA) - Hand and Arm Function | The Short Musculoskeletal function Assessment (SMFA) is a participant reported assessment of the impact a musculoskeletal condition on individual function and daily activities. This study used Short Musculoskeletal Function Assessment (SMFA) modules for Overall dysfunction, mobility, daily activities, hand and arm function, and emotional status. Scores range is 0-100. Lower scores indicate better function. Scores are standardized; the formula for standardization is: | Baseline | 
| Short Musculoskeletal Function Assessment (SMFA) - Emotional Status | The Short Musculoskeletal function Assessment (SMFA) is a participant reported assessment of the impact a musculoskeletal condition on individual function and daily activities. This study used Short Musculoskeletal Function Assessment (SMFA) modules for Overall dysfunction, mobility, daily activities, hand and arm function, and emotional status. Scores range is 0-100. Lower scores indicate better function. Scores are standardized; the formula for standardization is: Scores are standardized. The formula for standardization is: ((Actual total raw score - lowest possible raw score)/possible raw score range) *100 | Baseline | 
| Veterans RAND 12 Item Health Survey - Physical Component Summary | The Veterans RAND 12 Item Health Survey (VR-12) is a participant reported global health measure assessing the participant's overall perspective of their health status. Responses are summarized into 2 scores, a Physical Component Score (PCS) (range 0-100) and a Mental Component Score (MCS) (range 0-100). The 12 items correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health. The United States population average PCS and MCS are both 50 points. The United States population standard deviation is 10 points. Higher scores indicate better outcomes. | Baseline | 
| Veterans RAND 12 Item Health Survey (VR-12) - Mental Health Component Summary | The Veterans RAND 12 Item Health Survey (VR-12) is a participant reported global health measure assessing the participant's overall perspective of their health status. Responses are summarized into 2 scores, a Physical Component Score (PCS) (range 0-100) and a Mental Component Score (MCS) (range 0-100). The 12 items correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health. The United States population average PCS and MCS are both 50 points. The United States population standard deviation is 10 points. Higher scores indicate better outcomes. | Baseline | 
| 4 Step Square Test | The 4 step square test is an objective measure of agility. It is measured in seconds, with a range of > 0   +∞. Lower values represent better outcomes. (This measure is part of the change in functional performance composite measure calculated using the mean of participant's score across several objective performance measures of agility, strength and power, speed, and postural stability) | Post intervention (approx 4 weeks post IDEO fit) | 
| Illinois Agility Test | The Illinois Agility Test is an objective measure of agility. It is measured in seconds, with a range of > 0   +∞. Lower values represent better outcomes. (This measure is part of the change in functional performance composite measure calculated using the mean of participant's score across several objective performance measures of agility, strength and power, speed, and postural stability) | Post intervention (approx 4 weeks post IDEO fit) | 
| Sit to Stand Test | The Sit to Stand Test is an objective measure of strength and power. It is measured in seconds, with a range of > 0   +∞. Lower values represent better outcomes. (This measure is part of the change in functional performance composite measure calculated using the mean of participant's score across several objective performance measures of agility, strength and power, speed, and postural stability). | Post intervention (approx 4 weeks post IDEO fit) | 
| Timed Stair Assent Test | The Timed Stair Assent test is an objective measure of strength and power. It is measured in seconds, with a range of > 0   +∞. Lower values represent better outcomes. (This measure is part of the change in functional performance composite measure calculated using the mean of participant's score across several objective performance measures of agility, strength and power, speed, and postural stability). | Post intervention (approx 4 weeks post IDEO fit) | 
| Short Musculoskeletal Function Assessment (SMFA) - Overall Dysfunction | The Short Musculoskeletal function Assessment (SMFA) is a participant reported assessment of the impact a musculoskeletal condition on individual function and daily activities. This study used Short Musculoskeletal Function Assessment (SMFA) modules for Overall dysfunction, mobility, daily activities, hand and arm function, and emotional status. Scores range is 0-100. Lower scores indicate better function. Scores are standardized; the formula for standardization is: ((Actual total raw score - lowest possible raw score)/possible raw score range) *100. | 6 months | 
| Short Musculoskeletal Function Assessment (SMFA) - Mobility | The Short Musculoskeletal function Assessment (SMFA) is a participant reported assessment of the impact a musculoskeletal condition on individual function and daily activities. This study used Short Musculoskeletal Function Assessment (SMFA) modules for Overall dysfunction, mobility, daily activities, hand and arm function, and emotional status. Scores range is 0-100. Lower scores indicate better function. Scores are standardized; the formula for standardization is: ((Actual total raw score - lowest possible raw score)/possible raw score range) *100. | 6 months | 
| Short Musculoskeletal Function Assessment (SMFA) - Daily Activities | The Short Musculoskeletal function Assessment (SMFA) is a participant reported assessment of the impact a musculoskeletal condition on individual function and daily activities. This study used Short Musculoskeletal Function Assessment (SMFA) modules for Overall dysfunction, mobility, daily activities, hand and arm function, and emotional status. Scores range is 0-100. Lower scores indicate better function. Scores are standardized; the formula for standardization is: ((Actual total raw score - lowest possible raw score)/possible raw score range) *100. | 6 months | 
| Short Musculoskeletal Function Assessment (SMFA) - Hand and Arm Function | The Short Musculoskeletal function Assessment (SMFA) is a participant reported assessment of the impact a musculoskeletal condition on individual function and daily activities. This study used Short Musculoskeletal Function Assessment (SMFA) modules for Overall dysfunction, mobility, daily activities, hand and arm function, and emotional status. Scores range is 0-100. Lower scores indicate better function. Scores are standardized; the formula for standardization is: ((Actual total raw score - lowest possible raw score)/possible raw score range) *100. | 6 months | 
| Short Musculoskeletal Function Assessment (SMFA) - Emotional Status | The Short Musculoskeletal function Assessment (SMFA) is a participant reported assessment of the impact a musculoskeletal condition on individual function and daily activities. This study used Short Musculoskeletal Function Assessment (SMFA) modules for Overall dysfunction, mobility, daily activities, hand and arm function, and emotional status. Scores range is 0-100. Lower scores indicate better function. Scores are standardized; the formula for standardization is: ((Actual total raw score - lowest possible raw score)/possible raw score range) *100. | 6 months | 
| Veterans RAND 12 Item Health Survey (VR-12) - Physical Component Summary (PCS) | The Veterans RAND 12 Item Health Survey (VR-12) is a participant reported global health measure assessing the participant's overall perspective of their health status. Responses are summarized into 2 scores, a Physical Component Score (PCS) (range 0-100) and a Mental Component Score (MCS) (range 0-100). The 12 items correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health. The United States population average PCS and MCS are both 50 points. The United States population standard deviation is 10 points. Higher scores indicate better outcomes. | 6 months | 
| Veterans RAND 12 Item Health Survey (VR-12) Mental Health Component Summary (MCS) | The Veterans RAND 12 Item Health Survey (VR-12) is a participant reported global health measure assessing the participant's overall perspective of their health status. Responses are summarized into 2 scores, a Physical Component Score (PCS) (range 0-100) and a Mental Component Score (MCS) (range 0-100). The 12 items correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health. The United States population average PCS and MCS are both 50 points. The United States population standard deviation is 10 points. Higher scores indicate better outcomes. | 6 months | 
| Short Musculoskeletal Function Assessment (SMFA) - Overall Dysfunction | The Short Musculoskeletal function Assessment (SMFA) is a participant reported assessment of the impact a musculoskeletal condition on individual function and daily activities. This study used Short Musculoskeletal Function Assessment (SMFA) modules for Overall dysfunction, mobility, daily activities, hand and arm function, and emotional status. Scores range is 0-100. Lower scores indicate better function. Scores are standardized; the formula for standardization is: ((Actual total raw score - lowest possible raw score)/possible raw score range) *100 | 12 months | 
| Short Musculoskeletal Function Assessment (SMFA) - Mobility | The Short Musculoskeletal function Assessment (SMFA) is a participant reported assessment of the impact a musculoskeletal condition on individual function and daily activities. This study used Short Musculoskeletal Function Assessment (SMFA) modules for Overall dysfunction, mobility, daily activities, hand and arm function, and emotional status. Scores range is 0-100. Lower scores indicate better function. Scores are standardized; the formula for standardization is: ((Actual total raw score - lowest possible raw score)/possible raw score range) *100 | 12 months | 
| Short Musculoskeletal Function Assessment (SMFA) - Daily Activities | The Short Musculoskeletal function Assessment (SMFA) is a participant reported assessment of the impact a musculoskeletal condition on individual function and daily activities. This study used Short Musculoskeletal Function Assessment (SMFA) modules for Overall dysfunction, mobility, daily activities, hand and arm function, and emotional status. Scores range is 0-100. Lower scores indicate better function. Scores are standardized; the formula for standardization is: ((Actual total raw score - lowest possible raw score)/possible raw score range) *100 | 12 months | 
| Short Musculoskeletal Function Assessment (SMFA) - Hand and Arm Function | The Short Musculoskeletal function Assessment (SMFA) is a participant reported assessment of the impact a musculoskeletal condition on individual function and daily activities. This study used Short Musculoskeletal Function Assessment (SMFA) modules for Overall dysfunction, mobility, daily activities, hand and arm function, and emotional status. Scores range is 0-100. Lower scores indicate better function. Scores are standardized; the formula for standardization is: ((Actual total raw score - lowest possible raw score)/possible raw score range) *100 | 12 months | 
| Short Musculoskeletal Function Assessment (SMFA) - Emotional Status | The Short Musculoskeletal function Assessment (SMFA) is a participant reported assessment of the impact a musculoskeletal condition on individual function and daily activities. This study used Short Musculoskeletal Function Assessment (SMFA) modules for Overall dysfunction, mobility, daily activities, hand and arm function, and emotional status. Scores range is 0-100. Lower scores indicate better function. Scores are standardized; the formula for standardization is: ((Actual total raw score - lowest possible raw score)/possible raw score range) *100 | 12 months | 
| Veterans RAND 12 Item Health Survey (VR-12) - Physical Component Summary (PCS) | The Veterans RAND 12 Item Health Survey (VR-12) is a participant reported global health measure assessing the participant's overall perspective of their health status. Responses are summarized into 2 scores, a Physical Component Score (PCS) and a Mental Component Score (MCS). Scored on a 5 point Likert scale, the 12 items correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health. The United States population averages 50 points on both the PCS and MCS (scores may range from 0-100 on each). The United States population standard deviation is 10 points. Higher scores indicate better outcomes. | 12 months | 
| Veterans RAND 12 Item Health Survey (VR-12) - Mental Health Component Summary (MCS) | The Veterans RAND 12 Item Health Survey (VR-12) is a participant reported global health measure assessing the participant's overall perspective of their health status. Responses are summarized into 2 scores, a Physical Component Score (PCS) and a Mental Component Score (MCS). Scored on a 5 point Likert scale, the 12 items correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health. The United States population averages 50 points on both the PCS and MCS (scores may range from 0-100). The United States population standard deviation is 10 points. Higher scores indicate better outcomes. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Major extremity trauma, wounded warriors, IDEO, return to run