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Recruiting NCT05780502

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

Trial Parameters

Condition Musculoskeletal Injury
Sponsor Wake Forest University Health Sciences
Study Type OBSERVATIONAL
Phase N/A
Enrollment 370
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2015-05-06
Completion 2028-12
Interventions
Passive Dynamic Brace

Brief 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. 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.

Eligibility 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

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