Observational Study on an Integrated Orthotic and Rehabilitation Initiative for Musculoskeletal Injuries
This observational study is looking at how well an integrated approach, combining a custom brace called the Intrepid Dynamic Exoskeletal Orthosis (IDEO) with a high-intensity rehabilitation program (Return to Performance or RTP), helps people with musculoskeletal injuries. You might be able to join if you are at least 18 years old, have a customized exoskeletal orthosis device, and can give your informed consent. The researchers will measure success by looking at changes in your patient-reported outcomes (PROMIS 29 scores), how fast you walk, and how quickly you can climb stairs. The current recruitment status is unclear.
- Study design
- This is an observational study with a planned enrollment of 370 participants.
- What's involved
- You would have measurements taken at baseline, when your device is delivered, and then at 3, 6, and 12 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- You would be followed for 12 weeks after your device is delivered.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Use of an Integrated Orthotic and Rehabilitation Initiative for Treatment of Lower Extremity Musculoskeletal Disorders
At a glance
Conditions
NCT05780502
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Carolinas Medical Center
Charlotte, North Carolinano site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Joseph Hsu, MD · PRINCIPAL_INVESTIGATOR · Carolinas HealthCare
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Inclusion
Exclusion
What this trial measures
- Change in patient-reported outcomes measurement information system (PROMIS 29) scoresbaseline, 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 groundbaseline, 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 ascentbaseline, 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 testbaseline, 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)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 Runbaseline, 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 & Descendbaseline, 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.