Clinical trial Recruiting at 1 site Observational Ages 18 and up

Using a custom orthotic and rehabilitation program for lower limb injuries

Official title: Use of an Integrated Orthotic and Rehabilitation Initiative for Treatment of Lower Extremity Musculoskeletal Disorders

Run by Wake Forest University Health Sciences · NCT05780502 · Data updated 2026-11-12

This study is testing if using a special orthotic along with a focused rehab program can help people with lower limb injuries recover better and improve their performance.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment370 (estimated)
SponsorWake Forest University Health Sciences
Academic / other
Locations1 site (Charlotte, North Carolina)
StatusRecruiting
StartedMay 6, 2015
Main results expectedDecember 2028
Study endsDecember 2028
Registry record updatedMarch 12, 2026
Trial IDNCT05780502 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults aged 18 and older who are fitted with a customized exoskeletal orthosis and can provide informed consent.

Probably not a fit

Patients who are under 18 years of age, pregnant, or not fitted with a customized exoskeletal orthosis may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of the Intrepid Dynamic Exoskeletal Orthosis (IDEO) combined with a high-intensity rehabilitation program known as the Return to Performance (RTP) pathway for patients with lower extremity musculoskeletal disorders. Participants will be assessed before, during, and after their involvement in the RTP pathway to measure improvements in functional outcomes. The study aims to gather data on how this integrated approach impacts recovery and performance in a diverse patient population, including those with complex limb injuries and postoperative conditions.

Why it matters

Potential benefit: If successful, this initiative could significantly enhance recovery and functional ability for patients with lower extremity musculoskeletal disorders.

How similar studies have gone: Preliminary research has shown significant improvements in functional performance for similar approaches, indicating potential success for this study.

Who can join: the full rules

Show full inclusion / exclusion criteria
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 it's running

  • Carolinas Medical Center
    Charlotte, North Carolina, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.