RESUMEN
INTRODUCTION: The C-Brace microprocessor stance and swing control orthosis was designed to overcome safety and functional limitations of traditional knee-ankle-foot orthoses (KAFOs) for individuals with lower limb paresis. However, a systematic comparison to established KAFO types has not been performed in a bigger sample. METHODS: International multicenter, randomized, controlled, cross-over clinical trial. Legacy KAFO users at risk of falling were randomized to KAFO/C-Brace or C-Brace/KAFO use for three months with each orthosis. Primary outcome was balance assessed with the Berg Balance Scale (BBS). Secondary outcomes were falls, mobility, function, and quality of life. RESULTS: Intention-to-treat analysis with 102 participants. With the C-Brace, the BBS improved by 3.3 ± 6.3 points (p < 0.0001). Significantly fewer participants presented BBS scores <40 indicative of increased fall risk (16 vs. 36, p = 0.018). Mean falls reduced from 4.0 ± 16.8 to 1.1 ± 3.3 (p = 0.002). Outcomes for function, mobility, and quality of life showed significant improvements with the C-Brace. DISCUSSION: The improvements in fall risk and mobility can be attributed to the stumble recovery and controlled knee flexion during weight bearing of the C-Brace and have a positive impact on the quality of life of users. CONCLUSION: The C-Brace represents an option for KAFO users with increased fall risk and reduced mobility.
When prescribing traditional knee-ankle-foot orthoses (KAFOs), their known limitations, such as limited function and mobility, and the requirement to walk with compensatory mechanisms, especially on non-level terrains, should be considered.For patients with compromised balance and increased risk of falling when using a traditional KAFO, a microprocessor stance and swing control orthosis (MP-SSCO) may be considered as an orthotic option to reduce their fall risk.For patients with mobility restrictions using a traditional KAFO, a MP-SSCO may be considered to improve function, mobility, reintegration into normal living, and quality of life.