Impact of a dynamic ankle orthosis on acute pain and function in patients with mechanical foot and ankle pain

Background: Over two million Americans visit the doctor each year for foot and ankle pain stemming from a degenerative condition or injury. Ankle-foot orthoses can effectively manage symptoms, but traditional designs have limitations. This study investigates the acute impact of a novel "dynamic ankle-foot orthosis" ("orthosis") in populations with mechanical pain (from motion or weight-bearing). Methods: With and without the brace, participants (n = 25) performed standing, over-ground level walking, treadmill level walking, stair ascent, stair descent, single leg hold, squat, and sitting. Instrumented insoles captured in-shoe vertical forces and a visual analog scale was used to assess pain levels during each activity. Subsequently, the self-perceived impact of the orthosis on the patient's symptoms and function was ranked on a scale from -10 (most worsened) to +10 (most improved). Findings: Peak in-shoe force was reduced during level and stair walking (P < 0.05). Average perceived pain was 1.2 to 1.6 points lower in the orthosis than the unbraced control for the active tasks. The majority of participants reported that the brace improved their symptoms (n = 19), while a smaller group reported that the brace did not affect their symptoms (n = 5), although average function scores were improved for both groups (+2.4 to +4.5). The group of individuals with improved symptoms included cases of osteoarthritis, tendon dysfunction, chronic pain, sprains, and nerve disorders. Interpretation: The orthosis effectively improved pain symptoms and improved the ability of impaired individuals to complete functional activities of daily living such as level walking and stair walking.