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 (Ͼ1 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 (Pϭ0.003; parameter estimate 2.9; 95% CI, 1.2 to 4.6) and knee flexion coordination (Pϭ0.049). Conclusion-FNS-IM
Recent neuroscience methods have provided the basis upon which to develop effective gait training methods for recovery of the coordinated components of gait after neural injury. We determined that there was not an existing observational measure that was, at once, adequately comprehensive, scored in an objectively-based manner, and capable of assessing incremental improvements in the coordinated components of gait. Therefore, the purpose of this work was to use content valid procedures in order to develop a relatively inexpensive, more comprehensive measure, scored with an objectively-based system, capable of incrementally scoring improvements in given items, and that was both reliable and capable of discriminating treatment response for those who had a stroke. Eight neurorehabilitation specialists developed criteria for the gait measure, item content, and scoring method. In subjects following stroke (>12 months), the new measure was tested for intra- and inter-rater reliability using the Intraclass Correlation Coefficient; capability to detect treatment response using Wilcoxon Signed Ranks Test; and discrimination between treatment groups, using the Plum Ordinal Regression. The Gait Assessment and Intervention Tool (G.A.I.T.) is a 31-item measure of the coordinated movement components of gait and associated gait deficits. It exhibited the following advantages: comprehensive, objective-based scoring method, incremental measurement of improvement within given items. The G.A.I.T. had good intra- and inter-rater reliability (ICC=.98, p=.0001, 95% CI=.95, .99; ICC=.83, p=.007, 95% CI=.32, .96, respectively. The inexperienced clinician who had training, had an inter-rater reliability with an experienced rater of ICC=.99 (p=.0001, CI=.97, .999). The G.A.I.T. detected improvement in response to gait training for two types of interventions: comprehensive gait training (z=-2.93, p=.003); and comprehensive gait training plus functional electrical stimulation (FES; z=-3.3, p=.001). The G.A.I.T. was capable of discriminating between two gait training interventions, showing an additive advantage of FES to otherwise comparable comprehensive gait training (parameter estimate=1.72, p=.021; CI, .25, 3.1).
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.
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