Trial Outcomes & Findings for PRIORITI-MTF Study- Testing Patient Response to the IDEO (NCT NCT02158884)

NCT ID: NCT02158884

Last Updated: 2019-10-14

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 91 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2019-10-14

Participant Flow

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

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.

Participant milestones

Measure	IDEO Brace IDEO brace IDEO brace: All participants will receive the IDEO brace and a 4 week integrated "Return to Run" physical therapy program.
Baseline Assessment STARTED	91
Baseline Assessment COMPLETED	87
Baseline Assessment NOT COMPLETED	4
Intervention: IDEO and PT Program STARTED	87
Intervention: IDEO and PT Program COMPLETED	81
Intervention: IDEO and PT Program NOT COMPLETED	6
Post Intervention (~4 Weeks) STARTED	81
Post Intervention (~4 Weeks) COMPLETED	71
Post Intervention (~4 Weeks) NOT COMPLETED	10
6 Month Assessment STARTED	81
6 Month Assessment COMPLETED	61
6 Month Assessment NOT COMPLETED	20
12 Month Assessment STARTED	81
12 Month Assessment COMPLETED	64
12 Month Assessment NOT COMPLETED	17

Reasons for withdrawal

Measure	IDEO Brace IDEO brace IDEO brace: All participants will receive the IDEO brace and a 4 week integrated "Return to Run" physical therapy program.
Baseline Assessment Missed performance assessment	3
Baseline Assessment Missed SMFA	1
Intervention: IDEO and PT Program Did not complete PT intervention	6
Post Intervention (~4 Weeks) Did not complete performance assessment	10
6 Month Assessment Missed SMFA	20
12 Month Assessment Missed SMFA	17

Baseline Characteristics

As previously noted, only 81 participants completed the RTR PT program.

Baseline characteristics by cohort

Measure	IDEO Brace n=87 Participants IDEO brace IDEO brace: All participants will receive the IDEO brace and a 4 week integrated "Return to Run" physical therapy program.
Age, Categorical <=18 years	0 Participants n=87 Participants
Age, Categorical Between 18 and 65 years	87 Participants n=87 Participants
Age, Categorical >=65 years	0 Participants n=87 Participants
Age, Continuous	36.2 years STANDARD_DEVIATION 8.5 • n=81 Participants • As previously noted, only 81 participants completed the RTR PT program.
Sex: Female, Male Female	9 Participants n=81 Participants • Of the 87 participants that completed baseline assessments, 6 did not complete any of the RTR PT and were excluded from analysis.
Sex: Female, Male Male	72 Participants n=81 Participants • Of the 87 participants that completed baseline assessments, 6 did not complete any of the RTR PT and were excluded from analysis.
Race/Ethnicity, Customized Hispanic	10 Participants n=81 Participants • Of the 87 participants that completed baseline assessments, 6 did not complete any of the RTR PT and were excluded from analysis.
Race/Ethnicity, Customized Non-Hispanic non-white	15 Participants n=81 Participants • Of the 87 participants that completed baseline assessments, 6 did not complete any of the RTR PT and were excluded from analysis.
Race/Ethnicity, Customized Non-Hispanic white	54 Participants n=81 Participants • Of the 87 participants that completed baseline assessments, 6 did not complete any of the RTR PT and were excluded from analysis.
Race/Ethnicity, Customized Refuse/unknown/missing	2 Participants n=81 Participants • Of the 87 participants that completed baseline assessments, 6 did not complete any of the RTR PT and were excluded from analysis.
Region of Enrollment United States	81 participants n=81 Participants • Of the 87 participants that completed baseline assessments, 6 did not complete any of the RTR PT and were excluded from analysis.
Self Efficacy for managing a chronic disease 6 item scale	38.4 units on a scale STANDARD_DEVIATION 12.1 • n=81 Participants • 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.

PRIMARY outcome

Timeframe: Baseline

Population: 91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis.

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).

Outcome measures

Measure	IDEO Brace n=87 Participants IDEO brace IDEO brace: All participants will receive the IDEO brace.
Four Square Step Test	8.0 seconds Standard Deviation 2.9

PRIMARY outcome

Timeframe: Baseline

Population: 91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis.

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)

Outcome measures

Measure	IDEO Brace n=87 Participants IDEO brace IDEO brace: All participants will receive the IDEO brace.
Baseline Illinois Agility Test	31.5 seconds Standard Deviation 13.7

PRIMARY outcome

Timeframe: Baseline

Population: 91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis.

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 ~ +∞

Outcome measures

Measure	IDEO Brace n=87 Participants IDEO brace IDEO brace: All participants will receive the IDEO brace.
Sit to Stand Test	10.6 seconds Standard Deviation 3.9

PRIMARY outcome

Timeframe: Baseline

Population: 91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis.

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)

Outcome measures

Measure	IDEO Brace n=87 Participants IDEO brace IDEO brace: All participants will receive the IDEO brace.
Timed Stair Assent	6.2 seconds Standard Deviation 5.3

PRIMARY outcome

Timeframe: Baseline

Population: 91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis.

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)

Outcome measures

Measure	IDEO Brace n=87 Participants IDEO brace IDEO brace: All participants will receive the IDEO brace.
Shuttle Run	2.5 seconds Standard Deviation 1.7

PRIMARY outcome

Timeframe: Baseline

Population: 91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis.

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

Outcome measures

Measure	IDEO Brace n=87 Participants IDEO brace IDEO brace: All participants will receive the IDEO brace.
Short Musculoskeletal Function Assessment (SMFA) Overall Dysfunction (Items 1-34)	28.6 score on a scale Standard Deviation 13.2

PRIMARY outcome

Timeframe: Baseline

Population: 91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis.

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

Outcome measures

Measure	IDEO Brace n=87 Participants IDEO brace IDEO brace: All participants will receive the IDEO brace.
Short Musculoskeletal Function Assessment (SMFA) - Mobility	37.1 score on a scale Standard Deviation 16.6

PRIMARY outcome

Timeframe: Baseline

Population: 91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis.

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

Outcome measures

Measure	IDEO Brace n=87 Participants IDEO brace IDEO brace: All participants will receive the IDEO brace.
The Short Musculoskeletal Function Assessment (SMFA) - Daily Activities	31.0 score on a scale Standard Deviation 18.3

PRIMARY outcome

Timeframe: Baseline

Population: 91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis.

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:

Outcome measures

Measure	IDEO Brace n=87 Participants IDEO brace IDEO brace: All participants will receive the IDEO brace.
Short Musculoskeletal Function Assessment (SMFA) - Hand and Arm Function	2.0 score on a scale Standard Deviation 4.7

PRIMARY outcome

Timeframe: Baseline

Population: 91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis.

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

Outcome measures

Measure	IDEO Brace n=87 Participants IDEO brace IDEO brace: All participants will receive the IDEO brace.
Short Musculoskeletal Function Assessment (SMFA) - Emotional Status	44.4 score on a scale Standard Deviation 20.8

PRIMARY outcome

Timeframe: Baseline

Population: 91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis.

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.

Outcome measures

Measure	IDEO Brace n=87 Participants IDEO brace IDEO brace: All participants will receive the IDEO brace.
Veterans RAND 12 Item Health Survey - Physical Component Summary	32.9 score on a scale Standard Deviation 9.2

PRIMARY outcome

Timeframe: Baseline

Population: 91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis.

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.

Outcome measures

Measure	IDEO Brace n=87 Participants IDEO brace IDEO brace: All participants will receive the 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 outcome

Timeframe: 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.

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)

Outcome measures

Measure	IDEO Brace n=81 Participants IDEO brace IDEO brace: All participants will receive the IDEO brace.
4 Step Square Test	6.1 seconds Standard Deviation 1.9

PRIMARY outcome

Timeframe: 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.

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)

Outcome measures

Measure	IDEO Brace n=81 Participants IDEO brace IDEO brace: All participants will receive the IDEO brace.
Illinois Agility Test	22.3 seconds Standard Deviation 4.2

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	IDEO Brace n=81 Participants IDEO brace IDEO brace: All participants will receive the IDEO brace.
Sit to Stand Test	7.9 seconds Standard Deviation 2.1

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	IDEO Brace n=81 Participants IDEO brace IDEO brace: All participants will receive the IDEO brace.
Timed Stair Assent Test	4.2 seconds Standard Deviation 1.2

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	IDEO Brace n=61 Participants IDEO brace IDEO brace: All participants will receive the IDEO brace.
Short Musculoskeletal Function Assessment (SMFA) - Overall Dysfunction	24.9 score on a scale Standard Deviation 15.8

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	IDEO Brace n=61 Participants IDEO brace IDEO brace: All participants will receive the IDEO brace.
Short Musculoskeletal Function Assessment (SMFA) - Mobility	30.3 score on a scale Standard Deviation 19.2

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	IDEO Brace n=61 Participants IDEO brace IDEO brace: All participants will receive the IDEO brace.
Short Musculoskeletal Function Assessment (SMFA) - Daily Activities	25.2 score on a scale Standard Deviation 21.4

PRIMARY outcome

Timeframe: 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..

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.

Outcome measures

Measure	IDEO Brace n=61 Participants IDEO brace IDEO brace: All participants will receive the IDEO brace.
Short Musculoskeletal Function Assessment (SMFA) - Hand and Arm Function	3.2 score on a scale Standard Deviation 7.1

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	IDEO Brace n=61 Participants IDEO brace IDEO brace: All participants will receive the IDEO brace.
Short Musculoskeletal Function Assessment (SMFA) - Emotional Status	42.4 score on a scale Standard Deviation 22.7

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	IDEO Brace n=61 Participants IDEO brace IDEO brace: All participants will receive the 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 outcome

Timeframe: 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.

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.

Outcome measures

Measure	IDEO Brace n=61 Participants IDEO brace IDEO brace: All participants will receive the IDEO brace.
Veterans RAND 12 Item Health Survey (VR-12) Mental Health Component Summary (MCS)	52.6 score on a scale Standard Deviation 11.0

PRIMARY outcome

Timeframe: 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

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

Outcome measures

Measure	IDEO Brace n=64 Participants IDEO brace IDEO brace: All participants will receive the IDEO brace.
Short Musculoskeletal Function Assessment (SMFA) - Overall Dysfunction	23.1 score on a scale Standard Deviation 14.3

PRIMARY outcome

Timeframe: 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

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

Outcome measures

Measure	IDEO Brace n=64 Participants IDEO brace IDEO brace: All participants will receive the IDEO brace.
Short Musculoskeletal Function Assessment (SMFA) - Mobility	28.9 score on a scale Standard Deviation 17.2

PRIMARY outcome

Timeframe: 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

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

Outcome measures

Measure	IDEO Brace n=64 Participants IDEO brace IDEO brace: All participants will receive the IDEO brace.
Short Musculoskeletal Function Assessment (SMFA) - Daily Activities	23.1 score on a scale Standard Deviation 18.9

PRIMARY outcome

Timeframe: 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

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

Outcome measures

Measure	IDEO Brace n=64 Participants IDEO brace IDEO brace: All participants will receive the IDEO brace.
Short Musculoskeletal Function Assessment (SMFA) - Hand and Arm Function	3.0 score on a scale Standard Deviation 5.9

PRIMARY outcome

Timeframe: 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

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

Outcome measures

Measure	IDEO Brace n=64 Participants IDEO brace IDEO brace: All participants will receive the IDEO brace.
Short Musculoskeletal Function Assessment (SMFA) - Emotional Status	39.2 score on a scale Standard Deviation 23.0

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Measure	IDEO Brace n=64 Participants IDEO brace IDEO brace: All participants will receive the IDEO brace.
Veterans RAND 12 Item Health Survey (VR-12) - Physical Component Summary (PCS)	40.1 score on a scale Standard Deviation 11.0

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	IDEO Brace n=64 Participants IDEO brace IDEO brace: All participants will receive the 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

Adverse Events

IDEO Brace

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Susan Collins (Study Manager)

Major Extremity Trauma and Rehabilitation Consortium

Phone: 410 502 8966

Email: scolli21@jhu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place