Multisite Evaluation of a Custom Energy-Storing Carbon Fiber Orthosis for Patients with Residual Disability After Lower-Limb Trauma.

BACKGROUND: The Intrepid Dynamic Exoskeletal Orthosis (IDEO) is a custom energy-storing carbon fiber ankle-foot orthosis developed for lower-extremity trauma patients. Studies conducted at the military treatment facility where the IDEO was developed demonstrated benefits of the IDEO when used with the Return to Run Physical Therapy (RTR PT) program. The current study was designed to determine if results could be replicated at other military treatment facilities and to examine whether early performance gains in patient-reported functional outcomes remained at 12 months.

METHODS: Study participants included service members who had functional deficits that interfered with daily activities at least 1 year after a traumatic unilateral lower-extremity injury at or below the knee. Participants were evaluated before receiving the IDEO, immediately following completion of RTR PT, and at 6 and 12 months. Agility, strength/power, and speed were assessed using well-established performance tests. Self-reported function was measured using the Short Musculoskeletal Function Assessment (SMFA). The Orthotics and Prosthetics Users' Survey was administered to assess satisfaction with the IDEO. Of 87 participants with complete baseline data, 6 did not complete any physical therapy and were excluded from the analysis. Follow-up rates immediately following completion of the RTR PT and at 6 and 12 months were 88%, 75%, and 79%, respectively.

RESULTS: Compared with baseline, improvement at completion of RTR PT was observed in all but 1 performance test. SMFA scores for all domains except hand and arm function were lower (improved function) at 6 and 12 months. Satisfaction with the IDEO was high following completion of RTR PT, with some attenuation at the time of follow-up.

CONCLUSIONS: This study adds to the evidence supporting the efficacy of the IDEO coupled with RTR PT. However, despite improvement in both performance and self-reported functioning, deficits persist compared with population norms.

LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.