Clinical Outcomes with the Intrepid Dynamic Exoskeletal Orthosis: A Retrospective Analysis.

Introduction: Severe lower limb injuries have a negative impact on many aspects of an individual's life. One rehabilitative option for patients who have undergone limb salvage is the Intrepid Dynamic Exoskeletal Orthosis (IDEO). The IDEO is a custom-made dynamic response device which is used to restore function for patients with a wide variety of injuries. Clinical outcomes were routinely collected on patients fit with IDEOs at the Center for the Intrepid, Brooke Army Medical Center. The purpose of this retrospective study was to analyze the clinical outcomes collection process and the patient outcomes collected as part of routine clinical care. Methods: The Brooke Army Medical Center IRB approved this study and granted waivers of informed consent and HIPAA authorization. Electronic medical records were reviewed over an 18-month period from July 2014 to January 2016. Records were examined to obtain the date of IDEO delivery, date of outcomes form completion, responses on the forms, and to verify diagnosis or injury. Data gathered included wear time, IDEO comfort, pain with and without the IDEO, Lower Extremity Functional Scale scores with and without the IDEO, and global rating of change questions for everyday activities and high impact activities. Wilcoxon signed-ranked tests were used to compare pain and function with vs. without the IDEO. Results: During the 18-month period, new IDEOs were delivered to 156 unique patients. Outcomes forms were collected as part of routine clinical care from 90 of these 156 patients (58%). An additional nine forms were collected from patients who received their IDEOs prior to July 2014. In all, 99 outcomes forms were collected. Mean follow-up time from IDEO delivery to outcomes form completion was 35 31 days for the original 90 patients. The most common patient diagnoses were fracture, nerve injury, arthritis, and fusion. Responses on the forms indicated that patients were generally comfortable wearing their IDEOs (8.3 +/- 1.3 on a 0-10 scale) and wore them most of the day (10.7 +/- 3.4 hours per day). Improvement in pain (from 5.2 +/- 2.9 to 1.7 +/- 1.6 points on a 0-10 scale) and Lower Extremity Functional Scale scores (from 29.7 +/- 16.6 to 59.5 +/- 13.6 points) with the IDEO were both more than the minimal clinically important difference and were statistically significant (p < 0.001). Conclusion: This descriptive retrospective study demonstrated that it was feasible to collect clinical outcomes data which were relevant for characterizing the effects of IDEO use and enabled quantification of improvements in self-reported function and walking pain with the IDEO. Due to the retrospective nature of this study, limitations include missing data and the lack of any performance measures to complement the self-reported data. Clinical outcomes collection continues as a routine part of clinical care and there remains an ongoing aim to collect information on all patients to obtain an accurate assessment of devices and services and ultimately better serve our patients.