Neuromodulation to improve gait and balance function using a sensory neuroprosthesis in people who report insensate feet - A randomized control cross-over study.

Peripheral neuropathy may cause loss of sensory information from plantar cutaneous mechanoreceptors that is important for balance control and falls management. The current study investigated short-term effects of using Walkasins, an external lower-limb sensory neuroprosthesis, on clinical outcomes of balance and gait in persons who reported peripheral neuropathy and balance problems. The device replaces lost plantar sensation with tactile balance information that modulates cutaneous mechanoreceptors above the ankle where sensation is intact. Thirty-one male community-dwelling Veterans, 56-84 years old with insensate feet and balance problems participated. Initial Functional Gait Assessment, gait speed, and 4-Stage Balance Test outcomes were assessed. After initial assessment, subjects were randomly assigned to either wearing Walkasins turned ON, or OFF, and outcomes were re-assessed following a set of standardized balance exercises. Following a one-hour rest and washout period, treatments were crossed-over between groups and a third outcomes assessment was performed. Before cross-over, 10 of 15 subjects in the ON-then-OFF group improved their Functional Gait Assessment score by at least four points, the Minimal Clinically Important Difference, compared to 5 of 16 in the OFF-then-ON group. After cross-over, 7 of 16 subjects in the OFF-then-ON group improved by at least four points versus 2 of 15 in the ON-then-OFF group. ON treatment was associated with a Functional Gait Assessment improvement of 4.4 ± 3.7 points versus 1.5 ± 1.2 for the OFF treatment (p<0.01). Overall, Functional Gait Assessment scores changed from 15.2 ± 4.8 at initial assessment to 21.1 ± 5.2 after final assessment (p<0.001). At the end of the two treatment sessions, 16 of the 31 individuals had improved their Functional Gait Assessment score beyond 23, indicating normal fall-risk status. Future studies should investigate long-term benefits of the device to reduce fall risk and actual falls in patients with peripheral neuropathy and balance problems.