The C-Brace® microprocessor controlled stance and swing orthosis improves safety, mobility, and quality of life at one year: Interim results from a prospective registry.

Introduction: The C-Brace microprocessor-controlled stance and swing control orthosis has been shown to improve function, mobility, and quality of life. A systematic registry to gather long-term, real-world safety and effectiveness data in patients fit with a C-Brace has not been performed.

Methods: International multicenter registry. Patients undergoing routine C-Brace fittings were assessed at baseline and 1 year after fitting. Primary outcomes were fast walking speed (FWS) measured by 25-foot or 10-meter walk test, Timed Up and Go (TUG) and the Activity-specific Balance Confidence (ABC) Scale. Secondary and exploratory outcomes included the Patient-specific Functional Scale (PSFS), falls, pain, PROMIS Pain Interference (PI), and quality of life.

Results: 48 subjects with 1-year baseline and follow up data were analyzed. With the C-Brace, FWS improved by + 0.26 ± 0.33 m/s (p < .0001), TUG by -8.1 ± 14.6 sec (p < .0001), and ABC by + 24.9 ± 25.8% (p < .0001). Mean falls reduced from 33 ± 77 to 3.0 ± 5.6 (p = .0005). PSFS increased by 3.60 ± 2.34 points (p < .0001). Outcomes for pain, PI and quality of life showed significant improvements with the C-Brace.

Conclusion: The C-Brace is an effective option to improve safety, mobility, and quality of life for patients needing a KAFO for ambulation.