Leg Injuries, Trauma
Conditions
Keywords
Major extremity trauma, wounded warriors, IDEO, return to run
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)
Interventions
DEVICEIDEO brace
All participants will receive the IDEO brace.
Sponsors
Major Extremity Trauma Research Consortium
United States Department of Defense
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Ages 18-60 2. Currently two or more years out from a traumatic unilateral lower extremity injury at or below the knee 3. Healed fractures and able to fully weight bear 4. 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
1. Ankle plantarflexion or dorsiflexion weakness as a result of spinal cord injury or central nervous system pathology. 2. Non-ambulatory 3. Surgery on study limb anticipated in next 6 months 4. Medical or psychological conditions that would preclude functional testing (ex. severe traumatic brain injury, stroke, renal failure, heart disease, severe anemia) 5. Neurologic, musculoskeletal or other conditions affecting contralateral extremity preventing the study of a healthy control limb 6. Unable or unwilling to participate in two 4-week PT programs 7. Pregnancy 8. Non-English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Four Square Step Test | 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). |
| Baseline Illinois Agility Test | 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) |
| Sit to Stand Test | 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 \~ +∞ |
| Timed Stair Assent | 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) |
| Shuttle Run | 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) |
| Short Musculoskeletal Function Assessment (SMFA) Overall Dysfunction (Items 1-34) | 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 |
| Short Musculoskeletal Function Assessment (SMFA) - Mobility | 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 |
| The Short Musculoskeletal Function Assessment (SMFA) - Daily Activities | 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 |
| Short Musculoskeletal Function Assessment (SMFA) - Hand and Arm Function | 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: |
| Short Musculoskeletal Function Assessment (SMFA) - Emotional Status | 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 |
| Veterans RAND 12 Item Health Survey - Physical Component Summary | 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. |
| Veterans RAND 12 Item Health Survey (VR-12) - Mental Health Component Summary | 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. |
| 4 Step Square Test | 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) |
| Illinois Agility Test | 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) |
| Timed Stair Assent Test | 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). |
| Short Musculoskeletal Function Assessment (SMFA) - Overall Dysfunction | 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. |
| Short Musculoskeletal Function Assessment (SMFA) - Daily Activities | 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. |
| Veterans RAND 12 Item Health Survey (VR-12) - Physical Component Summary (PCS) | 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. |
| Veterans RAND 12 Item Health Survey (VR-12) Mental Health Component Summary (MCS) | 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. |
| Veterans RAND 12 Item Health Survey (VR-12) - Mental Health Component Summary (MCS) | 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. |
Countries
United States
Participant flow
Recruitment details
Subjects were screened and enrolled at 3 military treatment sites in the US.
Pre-assignment details
Study participants included service members who had functional deficits that interfered with daily activities at least 1 year after a traumatic unilateral lower-extremity injury at or below the knee. This is not a randomized study, all consented participants were provided with an IDEO brace and the Return to Run Physical Therapy program. Participants who completed the PT program are included in each follow up period. Missing a follow up does not exclude the participant from the next follow up.
Participants by arm
| Arm | Count |
|---|---|
| IDEO Brace IDEO brace
IDEO brace: All participants will receive the IDEO brace and a 4 week integrated Return to Run physical therapy program. | 87 |
| Total | 87 |
Baseline characteristics
| Characteristic | IDEO Brace |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 87 Participants |
| Age, Continuous | 36.2 years STANDARD_DEVIATION 8.5 |
| Race/Ethnicity, Customized Hispanic | 10 Participants |
| Race/Ethnicity, Customized Non-Hispanic non-white | 15 Participants |
| Race/Ethnicity, Customized Non-Hispanic white | 54 Participants |
| Race/Ethnicity, Customized Refuse/unknown/missing | 2 Participants |
| Region of Enrollment United States | 81 participants |
| Self Efficacy for managing a chronic disease 6 item scale | 38.4 units on a scale STANDARD_DEVIATION 12.1 |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 81 |
| other Total, other adverse events | 0 / 81 |
| serious Total, serious adverse events | 0 / 81 |
Outcome results
Primary
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)
Population: 91 consented at 3 military treatment facilities and received an IDEO. 81 completed the intervention and were included in analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDEO Brace | 4 Step Square Test | 6.1 seconds | Standard Deviation 1.9 |
Primary
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
Population: 91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDEO Brace | Baseline Illinois Agility Test | 31.5 seconds | Standard Deviation 13.7 |
Primary
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
Population: 91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDEO Brace | Four Square Step Test | 8.0 seconds | Standard Deviation 2.9 |
Primary
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)
Population: 91 consented at 3 military treatment facilities and received an IDEO. 81 completed the intervention and were included in analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDEO Brace | Illinois Agility Test | 22.3 seconds | Standard Deviation 4.2 |
Primary
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
Population: 91 consented at 3 military treatment facilities and received an IDEO (87 had complete baseline assessments). Of the 87, 6 (6.7%) did not participate in RTR PT sessions \& were excluded from analysis; of the 81 completing RTR, 10 missed performance assessment \& 7 did not complete patient reported outcome surveys, leaving 64 in the 12 month analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDEO Brace | Short Musculoskeletal Function Assessment (SMFA) - Daily Activities | 23.1 score on a scale | Standard Deviation 18.9 |
Primary
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
Population: 91 consented at 3 military treatment facilities \&received an IDEO (87 had complete baseline assessments). Of the 87, 6 (6.7%) did not participate in RTR PT sessions \& were excluded from analysis; of the 81 completing RTR, 10 did not do a performance assessment \& 10 missed patient reported outcome surveys leaving 61 in the 6 month analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDEO Brace | Short Musculoskeletal Function Assessment (SMFA) - Daily Activities | 25.2 score on a scale | Standard Deviation 21.4 |
Primary
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
Population: 91 consented at 3 military treatment facilities \&received an IDEO (87 had complete baseline assessments). Of the 87, 6 (6.7%) did not participate in RTR PT sessions \& were excluded from analysis; of the 81 completing RTR, 10 did not do a performance assessment \& 10 missed patient reported outcome surveys leaving 61 in the 6 month analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDEO Brace | Short Musculoskeletal Function Assessment (SMFA) - Emotional Status | 42.4 score on a scale | Standard Deviation 22.7 |
Primary
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
Population: 91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDEO Brace | Short Musculoskeletal Function Assessment (SMFA) - Emotional Status | 44.4 score on a scale | Standard Deviation 20.8 |
Primary
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
Population: 91 consented at 3 military treatment facilities and received an IDEO (87 had complete baseline assessments). Of the 87, 6 (6.7%) did not participate in RTR PT sessions \& were excluded from analysis; of the 81 completing RTR, 10 missed performance assessment \& 7 did not complete patient reported outcome surveys, leaving 64 in the 12 month analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDEO Brace | Short Musculoskeletal Function Assessment (SMFA) - Emotional Status | 39.2 score on a scale | Standard Deviation 23 |
Primary
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
Population: 91 consented at 3 military treatment facilities \&received an IDEO (87 had complete baseline assessments). Of the 87, 6 (6.7%) did not participate in RTR PT sessions \& were excluded from analysis; of the 81 completing RTR, 10 did not do a performance assessment \& 10 missed patient reported outcome surveys leaving 61 in the 6 month analysis..
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDEO Brace | Short Musculoskeletal Function Assessment (SMFA) - Hand and Arm Function | 3.2 score on a scale | Standard Deviation 7.1 |
Primary
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
Population: 91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDEO Brace | Short Musculoskeletal Function Assessment (SMFA) - Hand and Arm Function | 2.0 score on a scale | Standard Deviation 4.7 |
Primary
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
Population: 91 consented at 3 military treatment facilities and received an IDEO (87 had complete baseline assessments). Of the 87, 6 (6.7%) did not participate in RTR PT sessions \& were excluded from analysis; of the 81 completing RTR, 10 missed performance assessment \& 7 did not complete patient reported outcome surveys, leaving 64 in the 12 month analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDEO Brace | Short Musculoskeletal Function Assessment (SMFA) - Hand and Arm Function | 3.0 score on a scale | Standard Deviation 5.9 |
Primary
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
Population: 91 consented at 3 military treatment facilities and received an IDEO (87 had complete baseline assessments). Of the 87, 6 (6.7%) did not participate in RTR PT sessions \& were excluded from analysis; of the 81 completing RTR, 10 missed performance assessment \& 7 did not complete patient reported outcome surveys, leaving 64 in the 12 month analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDEO Brace | Short Musculoskeletal Function Assessment (SMFA) - Mobility | 28.9 score on a scale | Standard Deviation 17.2 |
Primary
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
Population: 91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDEO Brace | Short Musculoskeletal Function Assessment (SMFA) - Mobility | 37.1 score on a scale | Standard Deviation 16.6 |
Primary
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
Population: 91 consented at 3 military treatment facilities \&received an IDEO (87 had complete baseline assessments). Of the 87, 6 (6.7%) did not participate in RTR PT sessions \& were excluded from analysis; of the 81 completing RTR, 10 did not do a performance assessment \& 10 missed patient reported outcome surveys leaving 61 in the 6 month analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDEO Brace | Short Musculoskeletal Function Assessment (SMFA) - Mobility | 30.3 score on a scale | Standard Deviation 19.2 |
Primary
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
Population: 91 consented at 3 military treatment facilities \&received an IDEO (87 had complete baseline assessments). Of the 87, 6 (6.7%) did not participate in RTR PT sessions \& were excluded from analysis; of the 81 completing RTR, 10 did not do a performance assessment \& 10 missed patient reported outcome surveys leaving 61 in the 6 month analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDEO Brace | Short Musculoskeletal Function Assessment (SMFA) - Overall Dysfunction | 24.9 score on a scale | Standard Deviation 15.8 |
Primary
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
Population: 91 consented at 3 military treatment facilities and received an IDEO (87 had complete baseline assessments). Of the 87, 6 (6.7%) did not participate in RTR PT sessions \& were excluded from analysis; of the 81 completing RTR, 10 missed performance assessment \& 7 did not complete patient reported outcome surveys, leaving 64 in the 12 month analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDEO Brace | Short Musculoskeletal Function Assessment (SMFA) - Overall Dysfunction | 23.1 score on a scale | Standard Deviation 14.3 |
Primary
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
Population: 91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDEO Brace | Short Musculoskeletal Function Assessment (SMFA) Overall Dysfunction (Items 1-34) | 28.6 score on a scale | Standard Deviation 13.2 |
Primary
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
Population: 91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDEO Brace | Shuttle Run | 2.5 seconds | Standard Deviation 1.7 |
Primary
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)
Population: 91 consented at 3 military treatment facilities and received an IDEO. 81 completed the intervention and were included in analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDEO Brace | Sit to Stand Test | 7.9 seconds | Standard Deviation 2.1 |
Primary
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
Population: 91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDEO Brace | Sit to Stand Test | 10.6 seconds | Standard Deviation 3.9 |
Primary
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
Population: 91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDEO Brace | The Short Musculoskeletal Function Assessment (SMFA) - Daily Activities | 31.0 score on a scale | Standard Deviation 18.3 |
Primary
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
Population: 91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDEO Brace | Timed Stair Assent | 6.2 seconds | Standard Deviation 5.3 |
Primary
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)
Population: 91 consented at 3 military treatment facilities and received an IDEO. 81 completed the intervention and were included in analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDEO Brace | Timed Stair Assent Test | 4.2 seconds | Standard Deviation 1.2 |
Primary
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
Population: 91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDEO Brace | Veterans RAND 12 Item Health Survey - Physical Component Summary | 32.9 score on a scale | Standard Deviation 9.2 |
Primary
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
Population: 91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDEO Brace | Veterans RAND 12 Item Health Survey (VR-12) - Mental Health Component Summary | 53.2 score on a scale | Standard Deviation 11.7 |
Primary
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
Population: 91 consented at 3 military treatment facilities \& received an IDEO (87 had complete baseline assessments). Of the 87, 6 (6.7%) did not participate in RTR PT sessions \& were excluded from analysis; of the 81 completing RTR, 10 missed performance assessment \& 7 did not complete patient reported outcome surveys, leaving 64 in the 12 month analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDEO Brace | Veterans RAND 12 Item Health Survey (VR-12) - Mental Health Component Summary (MCS) | 53.5 score on a scale | Standard Deviation 10.2 |
Primary
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
Population: 91 consented at 3 military treatment facilities \&received an IDEO (87 had complete baseline assessments). Of the 87, 6 (6.7%) did not participate in RTR PT sessions \& were excluded from analysis; of the 81 completing RTR, 10 did not do a performance assessment \& 10 missed patient reported outcome surveys leaving 61 in the 6 month analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDEO Brace | Veterans RAND 12 Item Health Survey (VR-12) Mental Health Component Summary (MCS) | 52.6 score on a scale | Standard Deviation 11 |
Primary
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
Population: 91 consented at 3 military treatment facilities \&received an IDEO (87 had complete baseline assessments). Of the 87, 6 (6.7%) did not participate in RTR PT sessions \& were excluded from analysis; of the 81 completing RTR, 10 did not do a performance assessment \& 10 missed patient reported outcome surveys leaving 61 in the 6 month analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDEO Brace | Veterans RAND 12 Item Health Survey (VR-12) - Physical Component Summary (PCS) | 38.6 score on a scale | Standard Deviation 10.1 |
Primary
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
Population: 91 consented at 3 military treatment facilities and received an IDEO (87 had complete baseline assessments). Of the 87, 6 (6.7%) did not participate in RTR PT sessions \& were excluded from analysis; of the 81 completing RTR, 10 missed performance assessment \& 7 did not complete patient reported outcome surveys, leaving 64 in the 12 month analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDEO Brace | Veterans RAND 12 Item Health Survey (VR-12) - Physical Component Summary (PCS) | 40.1 score on a scale | Standard Deviation 11 |