NCT02158884

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 9, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

October 14, 2019

Completed
Last Updated

October 14, 2019

Status Verified

December 1, 2016

Enrollment Period

3.3 years

First QC Date

June 3, 2014

Results QC Date

December 13, 2018

Last Update Submit

October 11, 2019

Conditions

Leg InjuriesTrauma

Keywords

Major extremity traumawounded warriorsIDEOreturn to run

Outcome Measures

Primary Outcomes (30)

  • 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

Study Arms (1)

IDEO brace

OTHER

IDEO brace

Device: IDEO brace

Interventions

IDEO braceDEVICE

All participants will receive the IDEO brace.

Also known as: IDEO
IDEO brace

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Naval Medical Center San Diego

San Diego, California, 92134, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

San Antonio Center for the Intrepid

San Antonio, Texas, 78234-4504, United States

Location

MeSH Terms

Conditions

Leg InjuriesWounds and Injuries

Results Point of Contact

Title
Susan Collins (Study Manager)
Organization
Major Extremity Trauma and Rehabilitation Consortium
scolli21@jhu.edu
410 502 8966

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2014

First Posted

June 9, 2014

Study Start

June 1, 2014

Primary Completion

August 31, 2017

Study Completion

April 1, 2018

Last Updated

October 14, 2019

Results First Posted

October 14, 2019

Record last verified: 2016-12

Locations

US(3)