NCT05780502 · Wake Forest University Health Sciences
Use of an Integrated Orthotic and Rehabilitation Initiative for Treatment of Lower Extremity Musculoskeletal Disorders
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Passive Dynamic Brace
Patient receiving the Passive Dynamic Brace
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Minimum 18 years of age
- Fitted with a customized exoskeletal orthosis device
- Able to provide written informed consent
Exclusion criteria
- Less than 18 years of age
- Self-reported pregnancy
- Not fitted with a customized exoskeletal orthosis
- Unable or unwilling to provide written informed consent
Where
- Charlotte, North Carolina
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 12, 2026 · Source of record for eligibility and locations