A randomized controlled trial of functional neuromuscular stimulation in chronic stroke subjects

Background and Purpose - Conventional therapies fail to restore normal gait to many patients after stroke. The study purpose was to test response to coordination exercise, overground gait training, and weight-supported treadmill training, both with and without functional neuromuscular stimulation (FNS) using intramuscular (IM) electrodes (FNS-IM). Methods - In a randomized controlled trial, 32 subjects (> 1 year after stroke) were assigned to 1 of 2 groups: FNS-IM or No-FNS. Inclusion criteria included ability to walk independently but inability to execute a normal swing or stance phase. All subjects were treated 4 times per week for 12 weeks. The primary outcome measure, obtained by a blinded evaluator, was gait component execution, according to the Tinetti gait scale. Secondary measures were coordination, balance, and 6-minute walking distance. Results - Before treatment, there were no significant differences between the 2 groups for age, time since stroke, stroke severity, and each study measure. FNS-IM produced a statistically significant greater gain versus No-FNS for gait component execution (P = 0.003; parameter estimate 2.9; 95% CI, 1.2 to 4.6) and knee flexion coordination (P = 0.049). Conclusion - FNS-IM can have a significant advantage versus No-FNS in improving gait components and knee flexion coordination after stroke.