Recovery of coordinated gait: randomized controlled stroke trial of functional electrical stimulation (FES) versus no FES, with weight-supported treadmill and over-ground training.

Background: No single intervention restores the coordinated components of gait after stroke.

Objective: The authors tested the multimodal Gait Training Protocol, with or without functional electrical stimulation (FES), to improve volitional walking (without FES) in patients with persistent (>6 months) dyscoordinated gait.

Methods: A total of 53 subjects were stratified and randomly allocated to either FES with intramuscular (IM) electrodes (FES-IM) or No-FES. Both groups received 1.5-hour training sessions 4 times a week for 12 weeks of coordination exercises, body weight-supported treadmill training (BWSTT), and over-ground walking, provided with FES-IM or No-FES. The primary outcome was the Gait Assessment and Intervention Tool (G.A.I.T.) of coordinated movement components, with secondary measures, including manual muscle testing, isolated leg movements (Fugl-Meyer scale), 6-Minute Walk Test, and Locomotion/Mobility subscale of the Functional Independence Measure (FIM).

Results: No baseline differences in subject characteristics and measures were found. The G.A.I.T. showed an additive advantage with FES-IM versus No-FES (parameter statistic 1.10; P = .045, 95% CI = 0.023-2.179) at the end of training. For both FES-IM and No-FES, a within-group, pre/posttreatment gain was present for all measures (P < .05), and a continued benefit from mid- to posttreatment (P < .05) was present. For FES-IM, recovered coordinated gait persisted at 6-month follow-up but not for No-FES.

Conclusion: Improved gait coordination and function were produced by the multimodal Gait Training Protocol. FES-IM added significant gains that were maintained for 6 months after the completion of training.