Background. Effective treatment methods are needed for moderate/severely impairment chronic stroke. Objective. The questions were the following: (1) Is there need for long-dose therapy or is there a mid-treatment plateau? (2) Are the observed gains from the prior-studied protocol retained after treatment? Methods. Single-blind, stratified/randomized design, with 3 applied technology treatment groups, combined with motor learning, for long-duration treatment (300 hours of treatment). Measures were Arm Motor Ability Test time and coordination-function (AMAT-T, AMAT-F, respectively), acquired pre-/posttreatment and 3-month follow-up (3moF/U); Fugl-Meyer (FM), acquired similarly with addition of mid-treatment. Findings. There was no group difference in treatment response (P ≥ .16), therefore data were combined for remaining analyses (n = 31; except for FM pre/mid/post, n = 36). Pre-to-Mid-treatment and Mid-to-Posttreatment gains of FM were statistically and clinically significant (P < .0001; 4.7 points and P < .001; 5.1 points, respectively), indicating no plateau at 150 hours and benefit of second half of treatment. From baseline to 3moF/U: (1) FM gains were twice the clinically significant benchmark, (2) AMAT-F gains were greater than clinically significant benchmark, and (3) there was statistically significant improvement in FM (P < .0001); AMAT-F (P < .0001); AMAT-T (P < .0001). These gains indicate retained clinically and statistically significant gains at 3moFU. From posttreatment to 3moF/U, gains on FM were maintained. There were statistically significant gains in AMAT-F (P = .0379) and AMAT-T P = .003.

For neurorehabilitation to advance from art to science, it must become evidence-based. Historically, there has been a dearth of evidence from which to construct rehabilitation interventions that are properly framed, accurately targeted, and credibly measured. In many instances, evidence of treatment response has not been sufficiently robust to demonstrate a change in function that is clinically, statistically, and economically important. Research evidence of activity-dependent central nervous system (CNS) plasticity and the requisite motor learning principles can be used to construct an efficacious motor recovery intervention. Brain plasticity after stroke refers to the regeneration of brain neuronal structures and/or reorganization of the function of neurons. Not only can CNS structure and function change in response to injury, but also, the changes may be modified by "activity". For gait training or upper limb functional training for stroke survivors, the "activity" is motor behavior, including coordination and strengthening exercise and functional training that comprise motor learning. Critical principles of motor learning required for CNS activity-dependent plasticity include: close-to-normal movements, muscle activation driving practice of movement; focused attention, repetition of desired movements, and training specificity. The ultimate goal of rehabilitation is to restore function so that a satisfying quality of life can be experienced. Accurate measurement of dysfunction and its underlying impairments are critical to the development of accurately targeted interventions that are sufficiently robust to produce gains, not only in function, but also in quality of life. The Classification of Functioning, Disability, and Health Model (ICF) model of disablement, put forth by the World Health Organization, can provide not only some guidance in measurement level selection, but also can serve as a guide to incorporate function and quality of life enhancement as the ultimate goals of rehabilitation interventions. Based on the evidence and principles of activity-dependent plasticity and motor learning, we developed gait training and upper limb functional training protocols. Guided by the ICF model, we selected and developed measures with characteristics rendering them most likely to capture change in the targeted aspects of intervention, as well as measures having membership not only in the impairment, but also in the functional or life role participation levels contained in the ICF model. We measured response to innovative gait training using a knee flexion coordination measure, coefficient of coordination consistency (ACC) of relative hip/knee (H/K) movement across multiple steps (H/K ACC), and milestones of participation in life role activities. We measured response to upper limb functional training according to measures designed to quantify functional gains in response to treatment targeted at wrist/hand or shoulder elbow training (Arm Motor Ability Test for wrist/hand (AMAT W/H) or shoulder/elbow (AMAT S/E)). We found that there was a statistically significant advantage for adding FES-IM gait training to an otherwise comparable and comprehensive gait training, according to the following measures: H/K ACC, the measure of consistently executed hip/knee coordination during walking; a specific measure of isolated joint knee flexion coordination; and a measure of multiple coordinated gait components. Further, enhanced gains in gait component coordination were robust enough to result in achievement of milestones in participation in life role activities. In the upper limb functional training study, we found that robotics + motor learning (ROB ML; shoulder/elbow robotics practice plus motor learning) produced a statistically significant gain in AMAT S/E; whereas functional electrical stimulation + motor learning (FES ML) did not. We found that FES ML (wrist/hand FES plus motor learning) produced a statistically significant gain in AMAT W/H; whereas ROB ML did not. These results together, support the phenomenon of training specificity in that the most practiced joint movements improved in comparison to joint movements that were practiced at a lesser intensity and frequency. Both ROB ML and FES ML protocols addressed an array of impairments thought to underlie dysfunction. If we are willing to adhere to the ICF model, we accept the challenge that the goal of rehabilitation is life role participation, with functional improvement as in important intermediary step. The ICF model suggests that we intervene at multiple lower levels (e.g., pathology and impairment) in order to improve the higher levels of function and life role participation. The ICF model also suggests that we measure at each level. Not only can we then understand response to treatment at each level, but also, we can begin to understand relationships between levels (e.g., impairment and function). With the ICF model proffering the challenge of restoring life role participation, it then becomes important to design and test interventions that result in impairment gains sufficiently robust to be reflected in functional activities and further, in life role participation. Fortunately, CNS plasticity and associated motor learning principles can serve well as the basis for generating such interventions. These principles were useful in generating both efficacious gait training and efficacious upper limb functional training interventions. These principles led to the use of therapeutic agents (FES and robotics) so that close-to-normal movements could be practiced. These principles supported the use of specific therapeutic agents (BWSTT, FES, and robotics) so that sufficient movement repetition could be provided. These principles also supported incorporation of functional task practice and the demand of attention to task practice within the intervention. The ICF model provided the challenge to restore function and life role participation....

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.

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.