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Completed

NCT Number: NCT02158884

PRIORITI-MTF Study- Testing Patient Response to the IDEO

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)

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Key information

Conditions

Leg Injuries Trauma Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Naval Medical Center San Diego, San Diego, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IDEO brace

Device

All participants will receive the IDEO brace.

Other names: IDEO

Primary outcomes

  1. Four Square Step Test

    Time frame: Baseline

    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).

  2. Baseline Illinois Agility Test

    Time frame: Baseline

    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)

  3. Sit to Stand Test

    Time frame: Baseline

    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 ~ +∞

  4. Timed Stair Assent

    Time frame: Baseline

    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)

  5. Shuttle Run

    Time frame: Baseline

    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)

  6. Short Musculoskeletal Function Assessment (SMFA) Overall Dysfunction (Items 1-34)

    Time frame: Baseline

    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

  7. Short Musculoskeletal Function Assessment (SMFA) - Mobility

    Time frame: Baseline

    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

  8. The Short Musculoskeletal Function Assessment (SMFA) - Daily Activities

    Time frame: Baseline

    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

  9. Short Musculoskeletal Function Assessment (SMFA) - Hand and Arm Function

    Time frame: Baseline

    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:

  10. Short Musculoskeletal Function Assessment (SMFA) - Emotional Status

    Time frame: Baseline

    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

  11. Veterans RAND 12 Item Health Survey - Physical Component Summary

    Time frame: Baseline

    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.

  12. Veterans RAND 12 Item Health Survey (VR-12) - Mental Health Component Summary

    Time frame: Baseline

    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.

  13. 4 Step Square Test

    Time frame: Post intervention (approx 4 weeks post IDEO fit)

    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)

  14. Illinois Agility Test

    Time frame: Post intervention (approx 4 weeks post IDEO fit)

    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)

  15. Sit to Stand Test

    Time frame: Post intervention (approx 4 weeks post IDEO fit)

    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).

  16. Timed Stair Assent Test

    Time frame: Post intervention (approx 4 weeks post IDEO fit)

    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).

  17. Short Musculoskeletal Function Assessment (SMFA) - Overall Dysfunction

    Time frame: 6 months

    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.

  18. Short Musculoskeletal Function Assessment (SMFA) - Mobility

    Time frame: 6 months

    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.

  19. Short Musculoskeletal Function Assessment (SMFA) - Daily Activities

    Time frame: 6 months

    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.

  20. Short Musculoskeletal Function Assessment (SMFA) - Hand and Arm Function

    Time frame: 6 months

    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.

  21. Short Musculoskeletal Function Assessment (SMFA) - Emotional Status

    Time frame: 6 months

    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.

  22. Veterans RAND 12 Item Health Survey (VR-12) - Physical Component Summary (PCS)

    Time frame: 6 months

    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.

  23. Veterans RAND 12 Item Health Survey (VR-12) Mental Health Component Summary (MCS)

    Time frame: 6 months

    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.

  24. Short Musculoskeletal Function Assessment (SMFA) - Overall Dysfunction

    Time frame: 12 months

    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

  25. Short Musculoskeletal Function Assessment (SMFA) - Mobility

    Time frame: 12 months

    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

  26. Short Musculoskeletal Function Assessment (SMFA) - Daily Activities

    Time frame: 12 months

    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

  27. Short Musculoskeletal Function Assessment (SMFA) - Hand and Arm Function

    Time frame: 12 months

    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

  28. Short Musculoskeletal Function Assessment (SMFA) - Emotional Status

    Time frame: 12 months

    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

  29. Veterans RAND 12 Item Health Survey (VR-12) - Physical Component Summary (PCS)

    Time frame: 12 months

    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.

  30. Veterans RAND 12 Item Health Survey (VR-12) - Mental Health Component Summary (MCS)

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

Major Extremity Trauma Research Consortium

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

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

Acronym: PRIORITI-MTF

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Jun 9, 2014
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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