Reduction in Falls and Fall Risk after C-Brace Fitting: Interim Results from the C-Brace Registry

Research Objectives: To gather prospective baseline and follow-up data to characterize the safety and effectiveness of the C Brace compared to conventional KAFO. Both a reduction in Timed Up and Go time and improvement in Activities-specific Balance Confidence one year after fitting were hypothesized.

Design: Registry (before/after trial) with 3-year follow up.

Setting: Orthotic clinics

Participants: A convenience sample of 54 subjects were enrolled, 26 subjects with baseline and 6-month or 12-month data were available for follow up. Subjects were 9 female/17 male, mean age of 48 yrs and mean weight of 182 lbs., 7 were bilateral KAFO users. Most common diagnoses were incomplete spinal cord injury (7), trauma (5), and polio (3).

Interventions: The C-Brace is a microprocessor-controlled Stance and Swing Controlled Orthosis (SSCO®) developed to overcome the limitations of KAFOs that do not offer stumble recovery and damped knee flexion during weight-bearing or dynamic swing control.

Main Outcome Measures: Timed Up and Go (TUG), Activity-specific Balance Confidence Scale (ABC) and falls history.

Results: The average TUG time was 25.8±21.1s at baseline and improved to 15.9±12.3s at follow up with an average change of -9.9±17.9s (n=25). The average ABC score was 44.1±22.1 at baseline and improved to 70.7±19.3% at follow up with an average change of +28.9±28.0% (n=26). The mean number of falls was 30.1±84.2 at baseline (median of 3) and improved to 2.6±5.1 at follow up (median of 1) with an average change of -27.4±79.5 (median change of -1.5, n=22). No statistical tests performed.

Conclusions: Interim results from this prospective registry revealed that subjects demonstrated improvements in both objective and subjective measures of the risk of falling and reduction in fall frequency after C-Brace fitting.

Author(s) Disclosures: All authors are employees of Ottobock, the manufacturer of the C-Brace orthosis.