What this study is
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's being tested
- Passive Dynamic Brace
Intervention · BEHAVIORAL
Patient receiving the Passive Dynamic Brace
Study details
- Sponsor
- Wake Forest University Health Sciences
- Conditions
- Musculoskeletal Injury
- Enrolling
- 370 people
- Starts
- 2015-05-06
- Est. completion
- 2028-12
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Minimum 18 years of age
- Fitted with a customized exoskeletal orthosis device
- Able to provide written informed consent
You can't join if
- Less than 18 years of age
- Self-reported pregnancy
- Not fitted with a customized exoskeletal orthosis
- Unable or unwilling to provide written informed consent
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openCarolinas Medical Center
Charlotte, North Carolina, United States
- Rachel B Seymour, PhD · Contact
- Christine Churchill, MA · Contact
- Joseph R Hsu, MD · Principal investigator
- Rachel B Seymour, PhD · Sub-investigator
- Michael Bosse, MD · Sub-investigator
- Madhav Karunakar, MD · Sub-investigator
- Chris Adair, MD · Sub-investigator
Recruiting
Study team
Sponsor
Wake Forest University Health Sciences
Study ID IRB00082255
Principal investigator
Joseph Hsu, MD
Carolinas HealthCare
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.