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A microprocessor stance and swing control orthosis improves balance, risk of falling, mobility, function, and quality of life of individuals dependent on a knee-ankle-foot orthosis for ambulation.
Disability and Rehabilitation 2023 September 27
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.
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.
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