RESUMO
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.
RESUMO
Introduction: Studies with a powered prosthetic ankle-foot (PwrAF) found a reduction in sound knee loading compared to passive feet. Therefore, the aim of the present study was to determine whether anecdotal reports on reduced musculoskeletal pain and improved patient-reported mobility were isolated occurrences or reflect a common experience in PwrAF users. Methods: Two hundred and fifty individuals with transtibial amputation (TTA) who had been fitted a PwrAF in the past were invited to an online survey on average sound knee, amputated side knee, and low-back pain assessed with numerical pain rating scales (NPRS), the PROMIS Pain Interference scale, and the PLUS-M for patient-reported mobility in the free-living environment. Subjects rated their current foot and recalled the ratings for their previous foot. Recalled scores were adjusted for recall bias by clinically meaningful amounts following published recommendations. Statistical comparisons were performed using Wilcoxon's signed rank test. Results: Forty-six subjects, all male, with unilateral TTA provided data suitable for analysis. Eighteen individuals (39%) were current PwrAF users, whereas 28 subjects (61%) had reverted to a passive foot. After adjustment for recall bias, current PwrAF users reported significantly less sound knee pain than they recalled for use of a passive foot (-0.5 NPRS, p = 0.036). Current PwrAF users who recalled sound knee pain ≥4 NPRS with a passive foot reported significant and clinically meaningful improvements in sound knee pain (-2.5 NPRS, p = 0.038) and amputated side knee pain (-3 NPRS, p = 0.042). Current PwrAF users also reported significant and clinically meaningful improvements in patient-reported mobility (+4.6 points PLUS-M, p = 0.016). Individuals who had abandoned the PwrAF did not recall any differences between the feet. Discussion: Current PwrAF users reported significant and clinically meaningful improvements in patient-reported prosthetic mobility as well as sound knee and amputated side knee pain compared to recalled mobility and pain with passive feet used previously. However, a substantial proportion of individuals who had been fitted such a foot in the past did not recall improvements and had reverted to passive feet. The identification of individuals with unilateral TTA who are likely to benefit from a PwrAF remains a clinical challenge and requires further research.