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

Who can join

Ages 18 and older · All sexes

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

About the 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.

What is being tested

• Passive Dynamic Brace (behavioral)

Sponsor: Wake Forest University Health Sciences · Participants: 370 · Started: May 6, 2015

Contact the study team

• Rachel Seymour, PhD · Phone: 704-355-6969
• Christine Churchill, MA · Phone: 704-355-6947

Official record on ClinicalTrials.gov — NCT05780502

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.