CompletedNCT02158884PRIORITI-MTFUpdated Jul 2, 2026Results posted

PRIORITI-MTF Study- Testing Patient Response to the IDEO

An interventional study of IDEO brace in Leg Injuries and Trauma, sponsored by Major Extremity Trauma Research Consortium. Completed at 3 sites in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-07-02.

Sponsored by Major Extremity Trauma Research Consortium · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 91
Allocation: Not applicable
Ages: 18 Years to 60 Years
Sex: All

Study 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)

Conditions studied

Leg Injuries
Trauma

Browse trials for

Keywords

Major extremity trauma
wounded warriors
IDEO
return to run

In context

Leg Injuries

58 studies on the registry are indexed under Leg Injuries; 14 are open to participants now.

This study's enrollment of 91 is above the median of 50 across 40 interventional studies indexed under Leg Injuries.

Browse Leg Injuries studies →

Lead sponsor

Major Extremity Trauma Research Consortium is the lead sponsor of 32 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 91 participants (actual)

Study arms

Other
IDEO brace
IDEO brace
Device: IDEO brace

Interventions

DeviceIDEO brace
All participants will receive the IDEO brace.
Also known as: IDEO

What researchers measure

Primary outcomes

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).
Time frame: 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)
Time frame: 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 \~ +∞
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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:
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 12 months

Results

Posted Oct 14, 2019

Participant flow

Subjects were screened and enrolled at 3 military treatment sites in the US.

Baseline Assessment

Participant flow — Baseline Assessment
Milestone	IDEO Brace
Started	91
Completed	87
Not completed	4
Withdrew: Missed performance assessment	3
Withdrew: Missed smfa	1

Intervention: IDEO and PT Program

Participant flow — Intervention: IDEO and PT Program
Milestone	IDEO Brace
Started	87
Completed	81
Not completed	6
Withdrew: Did not complete pt intervention	6

Post Intervention (~4 Weeks)

Participant flow — Post Intervention (~4 Weeks)
Milestone	IDEO Brace
Started	81
Completed	71
Not completed	10
Withdrew: Did not complete performance assessment	10

6 Month Assessment

Participant flow — 6 Month Assessment
Milestone	IDEO Brace
Started	81
Completed	61
Not completed	20
Withdrew: Missed smfa	20

12 Month Assessment

Participant flow — 12 Month Assessment
Milestone	IDEO Brace
Started	81
Completed	64
Not completed	17
Withdrew: Missed smfa	17

Outcome measures

PrimaryFour 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).

Time frame:: Baseline
Reported as:: Mean · seconds

Four Square Step Test
seconds	IDEO Brace
Four Square Step Test	8.0 ± 2.9

PrimaryBaseline 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)

Time frame:: Baseline
Reported as:: Mean · seconds

Baseline Illinois Agility Test
seconds	IDEO Brace
Baseline Illinois Agility Test	31.5 ± 13.7

PrimarySit 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 \~ +∞

Time frame:: Baseline
Reported as:: Mean · seconds

Sit to Stand Test
seconds	IDEO Brace
Sit to Stand Test	10.6 ± 3.9

PrimaryTimed 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)

Time frame:: Baseline
Reported as:: Mean · seconds

Timed Stair Assent
seconds	IDEO Brace
Timed Stair Assent	6.2 ± 5.3

PrimaryShuttle 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)

Time frame:: Baseline
Reported as:: Mean · seconds

Shuttle Run
seconds	IDEO Brace
Shuttle Run	2.5 ± 1.7

PrimaryShort 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

Time frame:: Baseline
Reported as:: Mean · score on a scale

Short Musculoskeletal Function Assessment (SMFA) Overall Dysfunction (Items 1-34)
score on a scale	IDEO Brace
Short Musculoskeletal Function Assessment (SMFA) Overall Dysfunction (Items 1-34)	28.6 ± 13.2

PrimaryShort Musculoskeletal Function Assessment (SMFA) - Mobility

Time frame:: Baseline
Reported as:: Mean · score on a scale

Short Musculoskeletal Function Assessment (SMFA) - Mobility
score on a scale	IDEO Brace
Short Musculoskeletal Function Assessment (SMFA) - Mobility	37.1 ± 16.6

PrimaryThe 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

Time frame:: Baseline
Reported as:: Mean · score on a scale

The Short Musculoskeletal Function Assessment (SMFA) - Daily Activities
score on a scale	IDEO Brace
The Short Musculoskeletal Function Assessment (SMFA) - Daily Activities	31.0 ± 18.3

PrimaryShort Musculoskeletal Function Assessment (SMFA) - Hand and Arm Function

Time frame:: Baseline
Reported as:: Mean · score on a scale

Short Musculoskeletal Function Assessment (SMFA) - Hand and Arm Function
score on a scale	IDEO Brace
Short Musculoskeletal Function Assessment (SMFA) - Hand and Arm Function	2.0 ± 4.7

PrimaryShort 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

Time frame:: Baseline
Reported as:: Mean · score on a scale

Short Musculoskeletal Function Assessment (SMFA) - Emotional Status
score on a scale	IDEO Brace
Short Musculoskeletal Function Assessment (SMFA) - Emotional Status	44.4 ± 20.8

PrimaryVeterans 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.

Time frame:: Baseline
Reported as:: Mean · score on a scale

Veterans RAND 12 Item Health Survey - Physical Component Summary
score on a scale	IDEO Brace
Veterans RAND 12 Item Health Survey - Physical Component Summary	32.9 ± 9.2

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

Time frame:: Baseline
Reported as:: Mean · score on a scale

Veterans RAND 12 Item Health Survey (VR-12) - Mental Health Component Summary
score on a scale	IDEO Brace
Veterans RAND 12 Item Health Survey (VR-12) - Mental Health Component Summary	53.2 ± 11.7

Primary4 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)

Time frame:: Post intervention (approx 4 weeks post IDEO fit)
Reported as:: Mean · seconds

4 Step Square Test
seconds	IDEO Brace
4 Step Square Test	6.1 ± 1.9

PrimaryIllinois 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)

Time frame:: Post intervention (approx 4 weeks post IDEO fit)
Reported as:: Mean · seconds

Illinois Agility Test
seconds	IDEO Brace
Illinois Agility Test	22.3 ± 4.2

PrimarySit 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).

Time frame:: Post intervention (approx 4 weeks post IDEO fit)
Reported as:: Mean · seconds

Sit to Stand Test
seconds	IDEO Brace
Sit to Stand Test	7.9 ± 2.1

PrimaryTimed 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).

Time frame:: Post intervention (approx 4 weeks post IDEO fit)
Reported as:: Mean · seconds

Timed Stair Assent Test
seconds	IDEO Brace
Timed Stair Assent Test	4.2 ± 1.2

PrimaryShort Musculoskeletal Function Assessment (SMFA) - Overall Dysfunction

Time frame:: 6 months
Reported as:: Mean · score on a scale

Short Musculoskeletal Function Assessment (SMFA) - Overall Dysfunction
score on a scale	IDEO Brace
Short Musculoskeletal Function Assessment (SMFA) - Overall Dysfunction	24.9 ± 15.8

PrimaryShort Musculoskeletal Function Assessment (SMFA) - Mobility

Time frame:: 6 months
Reported as:: Mean · score on a scale

Short Musculoskeletal Function Assessment (SMFA) - Mobility
score on a scale	IDEO Brace
Short Musculoskeletal Function Assessment (SMFA) - Mobility	30.3 ± 19.2

PrimaryShort Musculoskeletal Function Assessment (SMFA) - Daily Activities

Time frame:: 6 months
Reported as:: Mean · score on a scale

Short Musculoskeletal Function Assessment (SMFA) - Daily Activities
score on a scale	IDEO Brace
Short Musculoskeletal Function Assessment (SMFA) - Daily Activities	25.2 ± 21.4

PrimaryShort Musculoskeletal Function Assessment (SMFA) - Hand and Arm Function

Time frame:: 6 months
Reported as:: Mean · score on a scale

Short Musculoskeletal Function Assessment (SMFA) - Hand and Arm Function
score on a scale	IDEO Brace
Short Musculoskeletal Function Assessment (SMFA) - Hand and Arm Function	3.2 ± 7.1

PrimaryShort Musculoskeletal Function Assessment (SMFA) - Emotional Status

Time frame:: 6 months
Reported as:: Mean · score on a scale

Short Musculoskeletal Function Assessment (SMFA) - Emotional Status
score on a scale	IDEO Brace
Short Musculoskeletal Function Assessment (SMFA) - Emotional Status	42.4 ± 22.7

PrimaryVeterans RAND 12 Item Health Survey (VR-12) - Physical Component Summary (PCS)

Time frame:: 6 months
Reported as:: Mean · score on a scale

Veterans RAND 12 Item Health Survey (VR-12) - Physical Component Summary (PCS)
score on a scale	IDEO Brace
Veterans RAND 12 Item Health Survey (VR-12) - Physical Component Summary (PCS)	38.6 ± 10.1

PrimaryVeterans RAND 12 Item Health Survey (VR-12) Mental Health Component Summary (MCS)

Time frame:: 6 months
Reported as:: Mean · score on a scale

Veterans RAND 12 Item Health Survey (VR-12) Mental Health Component Summary (MCS)
score on a scale	IDEO Brace
Veterans RAND 12 Item Health Survey (VR-12) Mental Health Component Summary (MCS)	52.6 ± 11.0

PrimaryShort Musculoskeletal Function Assessment (SMFA) - Overall Dysfunction

Time frame:: 12 months
Reported as:: Mean · score on a scale

Short Musculoskeletal Function Assessment (SMFA) - Overall Dysfunction
score on a scale	IDEO Brace
Short Musculoskeletal Function Assessment (SMFA) - Overall Dysfunction	23.1 ± 14.3

PrimaryShort Musculoskeletal Function Assessment (SMFA) - Mobility

Time frame:: 12 months
Reported as:: Mean · score on a scale

Short Musculoskeletal Function Assessment (SMFA) - Mobility
score on a scale	IDEO Brace
Short Musculoskeletal Function Assessment (SMFA) - Mobility	28.9 ± 17.2

PrimaryShort Musculoskeletal Function Assessment (SMFA) - Daily Activities

Time frame:: 12 months
Reported as:: Mean · score on a scale

Short Musculoskeletal Function Assessment (SMFA) - Daily Activities
score on a scale	IDEO Brace
Short Musculoskeletal Function Assessment (SMFA) - Daily Activities	23.1 ± 18.9

PrimaryShort Musculoskeletal Function Assessment (SMFA) - Hand and Arm Function

Time frame:: 12 months
Reported as:: Mean · score on a scale

Short Musculoskeletal Function Assessment (SMFA) - Hand and Arm Function
score on a scale	IDEO Brace
Short Musculoskeletal Function Assessment (SMFA) - Hand and Arm Function	3.0 ± 5.9

PrimaryShort Musculoskeletal Function Assessment (SMFA) - Emotional Status

Time frame:: 12 months
Reported as:: Mean · score on a scale

Short Musculoskeletal Function Assessment (SMFA) - Emotional Status
score on a scale	IDEO Brace
Short Musculoskeletal Function Assessment (SMFA) - Emotional Status	39.2 ± 23.0

PrimaryVeterans 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.

Time frame:: 12 months
Reported as:: Mean · score on a scale

Veterans RAND 12 Item Health Survey (VR-12) - Physical Component Summary (PCS)
score on a scale	IDEO Brace
Veterans RAND 12 Item Health Survey (VR-12) - Physical Component Summary (PCS)	40.1 ± 11.0

PrimaryVeterans 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.

Time frame:: 12 months
Reported as:: Mean · score on a scale

Veterans RAND 12 Item Health Survey (VR-12) - Mental Health Component Summary (MCS)
score on a scale	IDEO Brace
Veterans RAND 12 Item Health Survey (VR-12) - Mental Health Component Summary (MCS)	53.5 ± 10.2

Adverse events

Collected over Reported quarterly through study completion, approximately 12M.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
IDEO Brace	0/81 (0%)	0/81 (0%)	0/81 (0%)

Baseline characteristics

87 participants completed baseline assessments; 6 did not complete any of the RTR PT program and were excluded from analysis.

Age, Categorical
Age, Categorical(Participants)	IDEO Brace
<=18 years	0
Between 18 and 65 years	87
>=65 years	0

Age, Continuous
Age, Continuous(years)	IDEO Brace
Mean	36.2 ± 8.5

Sex: Female, Male
Sex: Female, Male(Participants)	IDEO Brace
Female	9
Male	72

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	IDEO Brace
Hispanic	10
Non-Hispanic non-white	15
Non-Hispanic white	54
Refuse/unknown/missing	2

Region of Enrollment
Region of Enrollment(participants)	IDEO Brace
United States	81

Self Efficacy for managing a chronic disease 6 item scale
Self Efficacy for managing a chronic disease 6 item scale(units on a scale)	IDEO Brace
Mean	38.4 ± 12.1

Study locations

3 sites

Naval Medical Center San Diego
San Diego, California 92134, United States
Walter Reed National Military Medical Center
Bethesda, Maryland 20889, United States
San Antonio Center for the Intrepid
San Antonio, Texas 78234-4504, United States

References and documents

Study documents

Protocol, analysis plan and consent form · Aug 31, 2015

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02158884
Lead sponsor: Major Extremity Trauma Research Consortium
Collaborators: United States Department of Defense
Responsible party: Sponsor
First posted: Jun 9, 2014
Start date: Jun 2014
Primary completion: Aug 31, 2017
Completion: Apr 2018
Results posted: Oct 14, 2019
Last update: Jul 2, 2026

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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