Musculoskeletal InjuryNCT05780502
Use of an Integrated Orthotic and Rehabilitation Initiative for Treatment of Lower Extremity Musculoskeletal Disorders
An observational study of Musculoskeletal Injury, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The Intrepid Dynamic Exoskeletal Orthosis (IDEO) is a custom, energy storage and return ankle orthosis proven to improve functional ability when coupled with a customized high-intensity rehabilitation program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Injury
- What is being tested?
- Passive Dynamic Brace
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 370 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2015to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The target population for this study will be those patients who have sustained a musculoskeletal injury and have been referred to be fitted for CUSTOMIZED EXOSKELETAL ORTHOSIS and RTR clinical pathway.
Who may be able to join
- Minimum 18 years of age
- Fitted with a customized exoskeletal orthosis device
- Able to provide written informed consent
Who cannot join
- Less than 18 years of age
- Self-reported pregnancy
- Not fitted with a customized exoskeletal orthosis
- Unable or unwilling to provide written informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Carolinas Medical Center
Charlotte, North Carolina, 28203
Rachel B Seymour, PhD
Christine Churchill, MA
About this study
The Intrepid Dynamic Exoskeletal Orthosis (IDEO) is a custom, energy storage and return ankle orthosis proven to improve functional ability when coupled with a customized high-intensity rehabilitation program. The Return to Performance (RTP) clinical pathway is the civilian version of the evidence-based Return To Run (RTR) clinical pathway. Together, the CUSTOMIZED EXOSKELETAL ORTHOSIS and RTP form a novel orthotic and rehabilitation initiative. A diverse group of patients has utilized the pathway to date, including combat wounded Soldiers undergoing complex limb salvage procedures, those with muscle and tendon deficiencies, patients with postoperative nerve palsies, various lower extremity fractures and many others. With this study we are seeking to determine how participation in CUSTOMIZED EXOSKELETAL ORTHOSIS RTP clinical pathway affects patient outcomes as determined by validated functional outcome measures. Subjects will undergo testing before, during and after completion of the clinical pathway.
Read the detailed description
BACKGROUND AND SIGNIFICANCE. Musculoskeletal injuries are among the most common and disabling conditions affecting adults in the United States of America1, and our military population is no exception. Functional limitations may result from chronic pain, muscle weakness and nerve injuries leading to substantial direct and indirect healthcare costs6-8. The RTR clinical pathway was originally created at Brooke Army Medical Center in order to address the needs of the combat wounded limb salvage population9,10 . These highly motivated patients were frustrated by the slow pace of recovery and rehabilitation after severe limb threatening injury, and were further disheartened when witnessing their amputee peers progressing through their rehabilitation quickly and with apparently fewer setbacks. As a result, there were many requests for delayed amputation of a reconstructed limb in the hopes of improving functional performance. The RTR combines a custom, carbon fiber energy storage and return ankle foot orthosis, the IDEO, with a high-intensity, sports-medicine based rehabilitation program. After initiation of the RTR clinical pathway, improvements in overall physical function were readily apparent, with many patients returning to recreational sports and even running11. Preliminary research demonstrated significant improvements in functional performance in these limb salvage Soldiers after completion of the RTR clinical pathway, along with a decrease in the rate of requests for delayed amputation12. However, at this time the only evidence exists on military patients. This is the first attempt to explore the impact of the CUSTOMIZED EXOSKELETAL ORTHOSIS and the RTP in the civilian population.
The natural history of severe lower extremity injury is disheartening. In the largest study of such injuries to date (the Lower Extremity Assessment Project, LEAP), all patients were found to be severely disabled at 2 and 7 years after injury13,14. This was regardless of treatment with amputation or limb salvage. In both groups, only 50% of patients had been able to return to work at 2 years. Additionally, functional outcomes were found to have worsened at 7 years after injury. There was no standardized rehabilitation program, and the use of orthotics was not standardized in this research. Although many factors were similar between the groups, one major difference was found in the cost of treatment. When the price of prosthetics were included in the analysis, the lifetime costs of amputation were three times greater than those of limb reconstruction15. Although the LEAP study group did not include active duty military patients (this was a specific exclusion criteria), we can reasonably assume that: (1) these are severely disabling injuries, (2) in the absence of standardized rehabilitation they do not improve with time, and (3) the costs of amputation are substantial when compared to limb salvage.
Although physical therapy is frequently recommended after musculoskeletal injury and treatment, standardized protocols are lackingl10,16. There is currently no "gold standard" rehabilitation program for patients who have sustained lower extremity injuries as a whole, or for specific injury patterns. Consequently, there is no accepted protocol against which to compare our current program in a randomized fashion.
Validated measures of functional assessment, as well as patient-based outcomes have been developed for this patient population. The Short Form 12 (SF-12), and Short Musculoskeletal Function Assessment (SMFA) have been extensively validated for use in musculoskeletal research17,18. The functional measures tested in this protocol have also been validated on a healthy, uninjured active duty population.
- Conditions
- Musculoskeletal Injury
- Being tested
- Passive Dynamic Brace
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive Dynamic BraceBehavioural
Patient receiving the Passive Dynamic Brace
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient-reported outcomes measurement information system (PROMIS 29) scores
The PROMIS-29 assesses seven health domains: physical function, anxiety, depression, fatigue, sleep disturbance, pain interference, and ability to participate in social roles and activities. Each of the seven domains has four questions which are scored on a five-point Likert scale. The PROMIS-29 scales will be scored using a T-score metric method available at the Assessment Center website (http://assessmentcenter.net). A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores mean more of the specific scale's construct, which may indicate a desirable or an undesirable outcome.
Measured: baseline, week 0 (time of delivery), 3, 6, 12
Performance Measure: Self-selected walking velocity (SSWV) over level ground
Subjects will walk between two floor markers spaced 15m apart on straight, level terrain. They will have a 5m lead-in to achieve a comfortable pace, and the time needed to traverse the next 15m will be recorded. Three trials will be performed for each testing session. Decrement in gait speed is identified as early indicator of reduced physical function in older adults population.20
Measured: baseline, week 0 (time of delivery), 3, 6, 12
Performance Measure: Timed stair ascent
Timed stair climbing is often used as an objective measure of mobility and power and has established test-retest reliability in older adults,21 as well as in a young, uninjured active duty population.19 Participants will be instructed to touch every step to the top of the stair case. After completing the ascent and timing has stopped, patients will-come back to the bottom of the stairs in a safe and controlled manner. Participants will be allowed to use the hand rail if needed. Every subject will perform three trials.
Measured: baseline, week 0 (time of delivery), 3, 6, 12
Performance Measure- 10 meter walk test
Participants complete a modified 10 meter walk test which involves the subject starting from a standing position, walking 5 meters at a comfortable pace, turning around, and then walking back 5 meters to the original starting point. The test is repeated twice for each subject.
Measured: baseline, week 0 (time of delivery), 3, 6, 12
Performance Measure- • Four Square Step Test (FSST)
Participants begin from a seated position and are directed to come to a full standing position without push off assistance from upper extremities and then return to a seated position without upper extremity assist.
Measured: baseline, week 0 (time of delivery), 3, 6, 12
Performance Measure- Twenty meters Shuttle Run
The 20-meter shuttle run/walk requires participants to go to a cone 10 meters away, turn around, and come back (a total of 20 meters distance). Participants are told to move between the cones as fast as they safely can, which may be walking or running based on their current functional level. They will perform three trials with at least a 15 second rest break between trials. Subjects will complete three trials.
Measured: baseline, week 0 (time of delivery), 3, 6, 12
Performance Measure- Modified Stair Ascent & Descend
Participants will be instructed to touch every step to the top of the stair case. After completing the ascent, they will be instructed to stop, turn around, stop, and descend the stair case. Participants will be allowed to use the hand rail if needed. Every subject will perform two trials. As with the modified 10-meter walk, subjects will hesitate for ½ second with each stop.
Measured: baseline, week 0 (time of delivery), 3, 6, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start6 May 2015
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal InjuryStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 370 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph Hsu, MD, Principal investigator, Carolinas HealthCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05780502
- Sponsor's protocol ID
- IRB00082255
- Other IDs
- 05-15-11E
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2023
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of an Integrated Orthotic and Rehabilitation Initiative for Treatment of Lower Extremity Musculoskeletal Disorders
- ClinicalTrials.gov ID
- NCT05780502
- Acronym / sponsor ID
- IRB00082255
- Conditions
- Musculoskeletal Injury
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 6 May 2015 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 22 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Intrepid Dynamic Exoskeletal Orthosis (IDEO) is a custom, energy storage and return ankle orthosis proven to improve functional ability when coupled with a customized high-intensity rehabilitation program. The Return to Performance (RTP) clinical pathway is the civilian version of the evidence-based Return To Run (RTR) clinical pathway. Together, the CUSTOMIZED EXOSKELETAL ORTHOSIS and RTP form a novel orthotic and rehabilitation initiative. A diverse group of patients has utilized the pathway to date, including combat wounded Soldiers undergoing complex limb salvage procedures, those with muscle and tendon deficiencies, patients with postoperative nerve palsies, various lower extremity fractures and many others. With this study we are seeking to determine how participation in CUSTOMIZED EXOSKELETAL ORTHOSIS RTP clinical pathway affects patient outcomes as determined by validated functional outcome measures. Subjects will undergo testing before, during and after completion of the clinical pathway.
Detailed description
BACKGROUND AND SIGNIFICANCE. Musculoskeletal injuries are among the most common and disabling conditions affecting adults in the United States of America1, and our military population is no exception. Functional limitations may result from chronic pain, muscle weakness and nerve injuries leading to substantial direct and indirect healthcare costs6-8. The RTR clinical pathway was originally created at Brooke Army Medical Center in order to address the needs of the combat wounded limb salvage population9,10 . These highly motivated patients were frustrated by the slow pace of recovery and rehabilitation after severe limb threatening injury, and were further disheartened when witnessing their amputee peers progressing through their rehabilitation quickly and with apparently fewer setbacks. As a result, there were many requests for delayed amputation of a reconstructed limb in the hopes of improving functional performance. The RTR combines a custom, carbon fiber energy storage and return ankle foot orthosis, the IDEO, with a high-intensity, sports-medicine based rehabilitation program. After initiation of the RTR clinical pathway, improvements in overall physical function were readily apparent, with many patients returning to recreational sports and even running11. Preliminary research demonstrated significant improvements in functional performance in these limb salvage Soldiers after completion of the RTR clinical pathway, along with a decrease in the rate of requests for delayed amputation12. However, at this time the only evidence exists on military patients. This is the first attempt to explore the impact of the CUSTOMIZED EXOSKELETAL ORTHOSIS and the RTP in the civilian population.
The natural history of severe lower extremity injury is disheartening. In the largest study of such injuries to date (the Lower Extremity Assessment Project, LEAP), all patients were found to be severely disabled at 2 and 7 years after injury13,14. This was regardless of treatment with amputation or limb salvage. In both groups, only 50% of patients had been able to return to work at 2 years. Additionally, functional outcomes were found to have worsened at 7 years after injury. There was no standardized rehabilitation program, and the use of orthotics was not standardized in this research. Although many factors were similar between the groups, one major difference was found in the cost of treatment. When the price of prosthetics were included in the analysis, the lifetime costs of amputation were three times greater than those of limb reconstruction15. Although the LEAP study group did not include active duty military patients (this was a specific exclusion criteria), we can reasonably assume that: (1) these are severely disabling injuries, (2) in the absence of standardized rehabilitation they do not improve with time, and (3) the costs of amputation are substantial when compared to limb salvage.
Although physical therapy is frequently recommended after musculoskeletal injury and treatment, standardized protocols are lackingl10,16. There is currently no "gold standard" rehabilitation program for patients who have sustained lower extremity injuries as a whole, or for specific injury patterns. Consequently, there is no accepted protocol against which to compare our current program in a randomized fashion.
Validated measures of functional assessment, as well as patient-based outcomes have been developed for this patient population. The Short Form 12 (SF-12), and Short Musculoskeletal Function Assessment (SMFA) have been extensively validated for use in musculoskeletal research17,18. The functional measures tested in this protocol have also been validated on a healthy, uninjured active duty population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population for this study will be those patients who have sustained a musculoskeletal injury and have been referred to be fitted for CUSTOMIZED EXOSKELETAL ORTHOSIS and RTR clinical pathway.
Key inclusion criteria (3 listed)
- Minimum 18 years of age
- Fitted with a customized exoskeletal orthosis device
- Able to provide written informed consent
Key exclusion criteria (4 listed)
- Less than 18 years of age
- Self-reported pregnancy
- Not fitted with a customized exoskeletal orthosis
- Unable or unwilling to provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Passive Dynamic BracePatient receiving the Passive Dynamic Brace | Behavioural | – |
Primary outcome
Change in patient-reported outcomes measurement information system (PROMIS 29) scores
Time frame: baseline, week 0 (time of delivery), 3, 6, 12
The PROMIS-29 assesses seven health domains: physical function, anxiety, depression, fatigue, sleep disturbance, pain interference, and ability to participate in social roles and activities. Each of the seven domains has four questions which are scored on a five-point Likert scale. The PROMIS-29 scales will be scored using a T-score metric method available at the Assessment Center website (http://assessmentcenter.net). A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores mean more of the specific scale's construct, which may indicate a desirable or an undesirable outcome.
Performance Measure: Self-selected walking velocity (SSWV) over level ground
Time frame: baseline, week 0 (time of delivery), 3, 6, 12
Subjects will walk between two floor markers spaced 15m apart on straight, level terrain. They will have a 5m lead-in to achieve a comfortable pace, and the time needed to traverse the next 15m will be recorded. Three trials will be performed for each testing session. Decrement in gait speed is identified as early indicator of reduced physical function in older adults population.20
Performance Measure: Timed stair ascent
Time frame: baseline, week 0 (time of delivery), 3, 6, 12
Timed stair climbing is often used as an objective measure of mobility and power and has established test-retest reliability in older adults,21 as well as in a young, uninjured active duty population.19 Participants will be instructed to touch every step to the top of the stair case. After completing the ascent and timing has stopped, patients will-come back to the bottom of the stairs in a safe and controlled manner. Participants will be allowed to use the hand rail if needed. Every subject will perform three trials.
Performance Measure- 10 meter walk test
Time frame: baseline, week 0 (time of delivery), 3, 6, 12
Participants complete a modified 10 meter walk test which involves the subject starting from a standing position, walking 5 meters at a comfortable pace, turning around, and then walking back 5 meters to the original starting point. The test is repeated twice for each subject.
Performance Measure- • Four Square Step Test (FSST)
Time frame: baseline, week 0 (time of delivery), 3, 6, 12
Participants begin from a seated position and are directed to come to a full standing position without push off assistance from upper extremities and then return to a seated position without upper extremity assist.
Performance Measure- Twenty meters Shuttle Run
Time frame: baseline, week 0 (time of delivery), 3, 6, 12
The 20-meter shuttle run/walk requires participants to go to a cone 10 meters away, turn around, and come back (a total of 20 meters distance). Participants are told to move between the cones as fast as they safely can, which may be walking or running based on their current functional level. They will perform three trials with at least a 15 second rest break between trials. Subjects will complete three trials.
Performance Measure- Modified Stair Ascent & Descend
Time frame: baseline, week 0 (time of delivery), 3, 6, 12
Participants will be instructed to touch every step to the top of the stair case. After completing the ascent, they will be instructed to stop, turn around, stop, and descend the stair case. Participants will be allowed to use the hand rail if needed. Every subject will perform two trials. As with the modified 10-meter walk, subjects will hesitate for ½ second with each stop.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joseph Hsu, MD principal investigator
Carolinas HealthCare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Injury, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Seymour, PhD (704-355-6969, Rachel.Seymour@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patient-reported outcomes measurement information system (PROMIS 29) scores (time frame: baseline, week 0 (time of delivery), 3, 6, 12). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.