Lundstrom Russell L, Klenow Tyler D, Morris Arri, Pobatschnig Barbara, Hibler Karl D, Kannenberg Andreas Hj
Department of Clinical Research & Services, Otto Bock Healthcare LP, Austin, TX, USA.
Department of Clinical Research & Services, Ottobock Healthcare Products GmbH, Vienna, AT, USA.
J Rehabil Assist Technol Eng. 2024 Aug 9;11:20556683241269539. doi: 10.1177/20556683241269539. eCollection 2024 Jan-Dec.
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.
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.
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 ( < .0001), TUG by -8.1 ± 14.6 sec ( < .0001), and ABC by + 24.9 ± 25.8% ( < .0001). Mean falls reduced from 33 ± 77 to 3.0 ± 5.6 ( = .0005). PSFS increased by 3.60 ± 2.34 points ( < .0001). Outcomes for pain, PI and quality of life showed significant improvements with the C-Brace.
The C-Brace is an effective option to improve safety, mobility, and quality of life for patients needing a KAFO for ambulation.
C型支具这种微处理器控制的站立和摆动控制矫形器已被证明可改善功能、移动能力和生活质量。尚未进行系统登记以收集使用C型支具患者的长期真实世界安全性和有效性数据。
国际多中心登记研究。对接受常规C型支具适配的患者在基线和适配后1年进行评估。主要结局指标为通过25英尺或10米步行测试测量的快走速度（FWS）、定时起立行走测试（TUG）和特定活动平衡信心量表（ABC）。次要和探索性结局指标包括患者特定功能量表（PSFS）、跌倒、疼痛、PROMIS疼痛干扰量表（PI）和生活质量。
分析了48例有1年基线和随访数据的受试者。使用C型支具后，FWS提高了+0.26±0.33米/秒（P<0.0001），TUG缩短了-8.1±14.6秒（P<0.0001），ABC提高了+24.9±25.8%（P<0.0001）。平均跌倒次数从33±77次减少至3.0±5.6次（P=0.0005）。PSFS增加了3.60±2.34分（P<0.0001）。C型支具在疼痛、PI和生活质量方面的结局指标有显著改善。
对于需要膝踝足矫形器辅助行走的患者，C型支具是改善安全性、移动能力和生活质量的有效选择。
