Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| United States Department of Defense | FED |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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)
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDEO brace | Other | IDEO brace |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IDEO brace | Device | All participants will receive the IDEO brace. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Four Square Step Test | The 4 step square test is an objective measure of agility. It is measured in seconds, with a range of > 0 ~ +∞. Lower values represent better outcomes. (This measure is part of the "change in functional performance" composite measure calculated using the mean of participant's score across several objective performance measures of agility, strength and power, speed, and postural stability). | Baseline |
| Baseline Illinois Agility Test | The Illinois Agility test is an objective measure of agility. It is measured in seconds, with a range of > 0 ~ +∞. Lower values represent better outcomes. (The Illinois Agility test is part of the "change in functional performance composite measure" calculated using the mean of participant's score across several objective performance measures of agility, strength and power, speed, and postural stability) | Baseline |
| Sit to Stand Test | The Sit to Stand test is an objective measure of strength and power. It is measured in seconds, with a range of > 0 ~ +∞. Lower values represent better outcomes. (The Sit to Stand test is part of the "change in functional performance" composite measure calculated using the mean of participant's score across several objective performance measures of agility, strength and power, speed, and postural stability)range: > 0 ~ +∞ | Baseline |
| Timed Stair Assent | The Timed Stair Assent test is an objective measure of strength and power. It is measured in seconds, with a range of > 0 ~ +∞. Lower values represent better outcomes. (The Timed Stair Assent test is part of the "change in functional performance" composite measure calculated using the mean of participant's score across several objective performance measures of agility, strength and power, speed, and postural stability) | Baseline |
| Shuttle Run |
Not provided
Not provided
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:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naval Medical Center San Diego | San Diego | California | 92134 | United States | ||
| Walter Reed National Military Medical Center |
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.
Subjects were screened and enrolled at 3 military treatment sites in the US.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | IDEO Brace | IDEO brace IDEO brace: All participants will receive the IDEO brace and a 4 week integrated "Return to Run" physical therapy program. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Assessment |
|
| |||||||||||||||||||||
| Intervention: IDEO and PT Program |
| ||||||||||||||||||||||
| Post Intervention (~4 Weeks) |
| ||||||||||||||||||||||
| 6 Month Assessment |
| ||||||||||||||||||||||
| 12 Month Assessment |
|
87 participants completed baseline assessments; 6 did not complete any of the RTR PT program and were excluded from analysis.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | IDEO Brace | IDEO brace IDEO brace: All participants will receive the IDEO brace and a 4 week integrated "Return to Run" physical therapy program. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis. | Posted | Mean | Standard Deviation | seconds | Baseline |
|
Reported quarterly through study completion, approximately 12M.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IDEO Brace | IDEO brace IDEO brace: All participants will receive the IDEO brace and a 4 week integrated "Return to Run" physical therapy program. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan Collins (Study Manager) | Major Extremity Trauma and Rehabilitation Consortium | 410 502 8966 | scolli21@jhu.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Aug 31, 2015 | Dec 13, 2018 | Prot_SAP_ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| Bethesda |
| Maryland |
| 20889 |
| United States |
| San Antonio Center for the Intrepid | San Antonio | Texas | 78234-4504 | United States |
|
|
|
|
| Participants |
|
| Age, Continuous | As previously noted, only 81 participants completed the RTR PT program. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Of the 87 participants that completed baseline assessments, 6 did not complete any of the RTR PT and were excluded from analysis. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Of the 87 participants that completed baseline assessments, 6 did not complete any of the RTR PT and were excluded from analysis. | Count of Participants | Participants |
|
| Region of Enrollment | Of the 87 participants that completed baseline assessments, 6 did not complete any of the RTR PT and were excluded from analysis. | Number | participants |
|
| Self Efficacy for managing a chronic disease 6 item scale | 6 item scale with observed range of 1-10; score for the full scale is mean of the 6 items. Higher score indicates higher self efficacy. | 91 participants were enrolled, 4 did not complete baseline assessments and were withdrawn from the study. An additional 6 received the IDEO but did not complete any of the Return to Run Physical Therapy (RTR PT) sessions and were excluded from analysis. | Mean | Standard Deviation | units on a scale |
|
| Units | Counts |
|---|
| Participants |
|
|
| 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) | 91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis. | Posted | Mean | Standard Deviation | seconds | Baseline |
|
|
|
| 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 ~ +∞ | 91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis. | Posted | Mean | Standard Deviation | seconds | Baseline |
|
|
|
| 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) | 91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis. | Posted | Mean | Standard Deviation | seconds | Baseline |
|
|
|
| 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) | 91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis. | Posted | Mean | Standard Deviation | seconds | Baseline |
|
|
|
| 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 | 91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| 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 | 91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| 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 | 91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| 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: | 91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| 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 | 91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| 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. | 91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| 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. | 91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| 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) | 91 consented at 3 military treatment facilities and received an IDEO. 81 completed the intervention and were included in analysis. | Posted | Mean | Standard Deviation | seconds | Post intervention (approx 4 weeks post IDEO fit) |
|
|
|
| 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) | 91 consented at 3 military treatment facilities and received an IDEO. 81 completed the intervention and were included in analysis. | Posted | Mean | Standard Deviation | seconds | Post intervention (approx 4 weeks post IDEO fit) |
|
|
|
| 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). | 91 consented at 3 military treatment facilities and received an IDEO. 81 completed the intervention and were included in analysis. | Posted | Mean | Standard Deviation | seconds | Post intervention (approx 4 weeks post IDEO fit) |
|
|
|
| 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). | 91 consented at 3 military treatment facilities and received an IDEO. 81 completed the intervention and were included in analysis. | Posted | Mean | Standard Deviation | seconds | Post intervention (approx 4 weeks post IDEO fit) |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
| 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. | 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.. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
| 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 | 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 | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
| 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 | 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 | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
| 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 | 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 | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
| 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 | 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 | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
| 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 | 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 | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
| 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. | 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 | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
| 0 |
| 81 |
| 0 |
| 81 |
| 0 |
| 81 |
Not provided
Not provided