PRIORITI-MTF Study- Testing Patient Response to the IDEO

Trauma Clinical Trial

— PRIORITI-MTF  

Official title:

Patient Response to an Integrated Orthotic and Rehabilitation Initiative for Traumatic Injuries for the Military Treatment Facilities (PRIORITI-MTF)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02158884
• Other study ID #: W81XWH-12-2-0032
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: April 2018

Study information

• Verified date: December 2016
• Source: Major Extremity Trauma Research Consortium
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: April 2018
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Leg Injuries
• Trauma

Intervention

Device:
• IDEO brace
All participants will receive the IDEO brace.

Locations

Country	Name	City	State
United States	Walter Reed National Military Medical Center	Bethesda	Maryland
United States	San Antonio Center for the Intrepid	San Antonio	Texas
United States	Naval Medical Center San Diego	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Major Extremity Trauma Research Consortium	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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 ~ +8. 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
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 ~ +8. 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
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 ~ +8. 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 ~ +8	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 ~ +8. 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
Primary	Shuttle Run	The Shuttle run test is an objective measure of agility. It is measured in seconds, with a range of > 0 ~ +8. 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
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	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	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	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:	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	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.	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.	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 ~ +8. 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)
Primary	Illinois Agility Test	The Illinois Agility Test is an objective measure of agility. It is measured in seconds, with a range of > 0 ~ +8. 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)
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 ~ +8. 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)
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 ~ +8. 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)
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.	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.	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.	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.	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.	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.	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.	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	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	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	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	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	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.	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.	12 months