Amplify Gait to Improve Locomotor Engagement in Spinal Cord Injury (AGILE SCI) trial: study protocol for an assessor blinded randomized controlled trial.

BACKGROUND: Among ambulatory people with incomplete spinal cord injury (iSCI), balance deficits are a primary factor limiting participation in walking activities. There is broad recognition that effective interventions are needed to enhance walking balance following iSCI. Interventions that amplify self-generated movements (e.g., error augmentation) can accelerate motor learning by intensifying sensorimotor feedback and facilitating exploration of motor control strategies. These features may be beneficial for retraining walking balance after iSCI. We have developed a cable-driven robot that creates a movement amplification environment during treadmill walking. The robot applies a continuous, laterally-directed, force to the pelvis that is proportional in magnitude to real-time lateral velocity. Our purpose is to investigate the effects of locomotor training in this movement amplification environment on walking balance. We hypothesize that for ambulatory people with iSCI, locomotor training in a movement amplification environment will be more effective for improving walking balance and participation in walking activities than locomotor training in a natural environment (no applied external forces). METHODS: We are conducting a two-arm parallel-assignment intervention. We will enroll 36 ambulatory participants with chronic iSCI. Participants will be randomized into either a control or experimental group. Each group will receive 20 locomotor training sessions. Training will be performed in either a traditional treadmill environment (control) or in a movement amplification environment (experimental). We will assess changes using measures that span the International Classification of Functioning, Disability and Health (ICF) framework including 1) clinical outcome measures of gait, balance, and quality of life, 2) biomechanical assessments of walking balance, and 3) participation in walking activities quantified by number of steps taken per day. DISCUSSION: Training walking balance in people with iSCI by amplifying the individual's own movement during walking is a radical departure from current practice and may result in new strategies for addressing balance impairments. Knowledge gained from this study will expand our understanding of how people with iSCI improve walking balance and how an intervention targeting walking balance affects participation in walking activities. Successful outcomes could motivate development of clinically feasible tools to replicate the movement amplification environment within clinical settings. TRIAL REGISTRATION: NCT04340063.

Predicting Discharge Walking Function With High-Intensity Stepping Training During Inpatient Rehabilitation in Nonambulatory Patients Poststroke.

OBJECTIVE: This cohort investigation identified primary predictors of discharge walking function of nonambulatory individuals poststroke with high-intensity training (HIT) during inpatient rehabilitation. DESIGN: Observational cohort investigation. SETTING: Inpatient rehabilitation. PARTICIPANTS: Data were collected from individuals (N=257) <6 months poststroke who required assistance to walk at admission. INTERVENTION: Clinical physical therapy interventions attempted to maximize stepping practice at higher intensities. MAIN OUTCOME MEASURES: Primary outcomes included the discharge level of assistance required during walking (minimal or no assistance) and attainment of specific gait speed thresholds (0.4 and 0.8 m/s) during the 10-m walk test. Independent predictors were demographics, training interventions (including steps/day), baseline Berg Balance Scale (BBS), and paretic leg strength. RESULTS: Participants performed a median (interquartile range) of 1270 (533-2297) steps per day throughout inpatient rehabilitation, with significant differences between those who walked with versus without assistance at discharge. Logistic regressions indicate steps per day was a primary predictor of unassisted walking recovery; removal of steps per day resulted in primary predictors of baseline BBS and strength. Receiver operating characteristic (ROC) analyses indicate significant areas under the curve for BBS and relatively low cutoff scores of 5.5 points at admission to walk without assistance at any speed. ROC analyses performed using 1-week outcomes indicate BBS scores of 5-17 points were needed to achieve locomotor thresholds. CONCLUSION: Stepping activity, BBS, and paretic leg strength were primary predictors of walking outcomes in patients performing HIT, and ROC analyses indicated recovery of independent walking could be achieved in low functioning patients early poststroke.

The Value of High Intensity Locomotor Training Applied to Patients With Acute-Onset Neurologic Injury.

Long-standing research in animal models and humans with stroke or incomplete spinal cord injury (iSCI) indicate that specific physical training variables, such as the specificity and amount of practice, may influence neurologic recovery and locomotor function. More recent data highlight the contributions of exercise intensity, as estimated indirectly by cardiovascular exertion, as potentially more important than previously considered. The effects of exercise intensity are well described in neurologically intact individuals, although confusion regarding the definitions of intensity and safety concerns have limited its implementation during physical rehabilitation of patients with neurologic injury. The purpose of this review is to delineate some of the evidence regarding the effects of exercise intensity during locomotor training in patients with stroke and iSCI. We provide specific definitions of exercise intensity used within the literature, describe methods used to ensure appropriate levels of exertion, and discuss potential adverse events and safety concerns during its application. Further details on the effects of locomotor training intensity on clinical outcomes, and on neuromuscular and cardiovascular function will be addressed as available. Existing literature across multiple studies and meta-analyses reveals that exercise training intensity is likely a major factor that can influence locomotor function after neurologic injury. To extend these findings, we describe previous attempts to implement moderate to high intensity interventions during physical rehabilitation of patients with neurologic injury, including the utility of specific strategies to facilitate implementation, and to navigate potential barriers that may arise during implementation efforts.

Contributions of Stepping Intensity and Variability to Mobility in Individuals Poststroke.

Background and Purpose- The amount of task-specific stepping practice provided during rehabilitation poststroke can influence locomotor recovery and reflects one aspect of exercise dose that can affect the efficacy of specific interventions. Emerging data suggest that markedly increasing the intensity and variability of stepping practice may also be critical, although such strategies are discouraged during traditional rehabilitation. The goal of this study was to determine the individual and combined contributions of intensity and variability of stepping practice to improving walking speed and distance in individuals poststroke. Methods- This phase 2, randomized, blinded assessor clinical trial was performed between May 2015 and November 2018. Individuals between 18 and 85 years old with hemiparesis poststroke of >6 months duration were recruited. Of the 152 individuals screened, 97 were randomly assigned to 1 of 3 training groups, with 90 completing >10 sessions. Interventions consisted of either high-intensity stepping (70%-80% heart rate reserve) of variable, difficult stepping tasks (high variable), high-intensity stepping performing only forward walking (high forward), and low-intensity stepping in variable contexts at 30% to 40% heart rate reserve (low variable). Participants received up to 30 sessions over 2 months, with testing at baseline, post-training, and a 3-month follow-up. Primary outcomes included walking speeds and timed distance, with secondary measures of dynamic balance, transfers, spatiotemporal kinematics, and metabolic measures. Results- All walking gains were significantly greater following either high-intensity group versus low-variable training (all P<0.001) with significant correlations with stepping amount and rate (r=0.48-60; P<0.01). Additional gains in spatiotemporal symmetry were observed with high-intensity training, and balance confidence increased only following high-variable training in individuals with severe impairments. Conclusions- High-intensity stepping training resulted in greater improvements in walking ability and gait symmetry than low-intensity training in individuals with chronic stroke, with potential greater improvements in balance confidence. Clinical Trial Registration- URL: https://www.clinicaltrials.gov. Unique identifier: NCT02507466.

Exercise-Induced Alterations in Sympathetic-Somatomotor Coupling in Incomplete Spinal Cord Injury.

The aim of this study was to understand how high- and low-intensity locomotor training (LT) affects sympathetic-somatomotor (SS) coupling in people with incomplete spinal cord injury (SCI). Proper coupling between sympathetic and somatomotor systems allows controlled regulation of cardiovascular responses to exercise. In people with SCI, altered connectivity between descending pathways and spinal segments impairs sympathetic and somatomotor coordination, which may have deleterious effects during exercise and limit rehabilitation outcomes. We postulated that high-intensity LT, which repeatedly engages SS systems, would alter SS coupling. Thirteen individuals (50 ± 7.2 years) with motor incomplete spinal cord injuries (American Spinal Injury Association Impairment Scale C or D; injury level >T6) participated in a locomotor treadmill training program. Patients were randomized into either a high-intensity (high-LT; 70-85% of maximum predicted heart rate; n = 6) group or a low-intensity (low-LT; 50-65% of maximum predicted heart rate; n = 7) group and completed up to 20 LT training sessions over 4-6 weeks, 3-5 days/week. Before and after taining, we tested SS coupling by eliciting reflexive sympathetic activity through a cold stimulation, noxious stimulation, and a mental math task while we measured tendon reflexes, blood pressure, and heart rate. Participants who completed high- versus low-LT exhibited significant decreases in reflex torques during triggered sympathetic activity (cold: -83 vs. 13%, p < 0.01; pain: -65 vs. 54%, p < 0.05; mental math: -43 vs. 41%; p < 0.05). Mean arterial pressure responses to sympathetic stimuli were slightly higher following high- versus low-LT (cold: 30 vs. -1.5%; pain: 6 vs. -12%; mental math: 5 vs. 7%), although differences were not statistically significant. These results suggest that high-LT may be advantageous to low-LT to improve SS coupling in people with incomplete SCI.

Cardiopulmonary Responses During Clinical and Laboratory Gait Assessments in People With Chronic Stroke.

Background: The 6-Minute Walk Test (6MWT) is a common clinical assessment used to evaluate locomotor function in patients after stroke. Previous work suggests the 6MWT can estimate peak metabolic capacity (VO2peak) without cardiorespiratory assessments during graded exercise tests (GXTs), which may assist with exercise prescription. However, selected research also indicated increased heart rates (HRs) during 6MWTs beyond levels considered safe without GXTs. Objective: The goal of this study was to examine cardiorespiratory responses during 6MWTs and GXTs in individuals with chronic stroke and their associations with demographic or clinical characteristics. Design: The study used a cross-sectional observational design. Methods: Cardiorespiratory responses were assessed during 6MWTs at self-selected velocity (SSV) and fastest velocity (FV), and during GXTs. Secondary assessments included the lower extremity Fugl-Meyer Assessment, Functional Gait Assessment, gait speeds, and daily stepping activity. Correlation and regression analyses were used to evaluate associations between locomotor performance, cardiorespiratory responses, and clinical and demographic characteristics. Results: Average HRs during 6MWT-FV were 72% to 76% of the age-predicted maximum (HRmax), with 20% of participants exceeding 85% predicted HRmax. When normalized to HRs during GXTs, HRs during 6MWT-FV were 86% to 88% of observed HRmax. Primary predictors of increased HRs during 6MWTs were resting HR, body mass index, and daily stepping. Distance during 6MWT-FV was a significant predictor of VO2peak in combination with other variables. Electrocardiographic abnormalities were observed in >80% of participants at rest and 31% demonstrated distinct abnormalities during GXTs, which were not related to 6MWT or GXT performance. Limitations: In addition to sample size, a primary limitation involved the ability to accurately predict or measure HRmax in patients with motor dysfunction after stroke. Conclusions: Cardiac responses were higher than anticipated during 6MWTs and often exceeded recommended HR thresholds. Clinicians should closely monitor cardiorespiratory responses during 6MWTs.

High-Intensity Variable Stepping Training in Patients With Motor Incomplete Spinal Cord Injury: A Case Series.

BACKGROUND AND PURPOSE: Previous data suggest that large amounts of high-intensity stepping training in variable contexts (tasks and environments) may improve locomotor function, aerobic capacity, and treadmill gait kinematics in individuals poststroke. Whether similar training strategies are tolerated and efficacious for patients with other acute-onset neurological diagnoses, such as motor incomplete spinal cord injury (iSCI), is unknown. Individuals with iSCI potentially have greater bilateral impairments. This case series evaluated the feasibility and preliminary short- and long-term efficacy of high-intensity variable stepping practice in ambulatory participants for more than 1 year post-iSCI. CASE SERIES DESCRIPTION: Four participants with iSCI (neurological levels C5-T3) completed up to 40 one-hour sessions over 3 to 4 months. Stepping training in variable contexts was performed at up to 85% maximum predicted heart rate, with feasibility measures of patient tolerance, total steps/session, and intensity of training. Clinical measures of locomotor function, balance, peak metabolic capacity, and gait kinematics during graded treadmill assessments were performed at baseline and posttraining, with more than 1-year follow-up. OUTCOMES: Participants completed 24 to 40 sessions over 8 to 15 weeks, averaging 2222 ± 653 steps per session, with primary adverse events of fatigue and muscle soreness. Modest improvements in locomotor capacity where observed at posttraining, with variable changes in lower extremity kinematics during treadmill walking. DISCUSSION: High-intensity, variable stepping training was feasible and tolerated by participants with iSCI although only modest gains in gait function or quality were observed. The utility of this intervention in patients with more profound impairments may be limited.Video Abstract available for more insights from the authors (see Video, Supplemental Digital Content 1, http://links.lww.com/JNPT/A200).

Effects of Training Intensity on Locomotor Performance in Individuals With Chronic Spinal Cord Injury: A Randomized Crossover Study.

BACKGROUND: Many physical interventions can improve locomotor function in individuals with motor incomplete spinal cord injury (iSCI), although the training parameters that maximize recovery are not clear. Previous studies in individuals with other neurologic injuries suggest the intensity of locomotor training (LT) may positively influence walking outcomes. However, the effects of intensity during training of individuals with iSCI have not been tested. OBJECTIVE: The purpose of this pilot, blinded-assessor randomized trial was to evaluate the effects of LT intensity on walking outcomes in individuals with iSCI. METHODS: Using a crossover design, ambulatory participants with iSCI >1 year duration performed either high- or low-intensity LT for ≤20 sessions over 4 to 6 weeks. Four weeks following completion, the training interventions were alternated. Targeted intensities focused on achieving specific ranges of heart rate (HR) or ratings of perceived exertion (RPE), with intensity manipulated by increasing speeds or applying loads. RESULTS: Significantly greater increases in peak treadmill speeds (0.18 vs 0.02 m/s) and secondary measures of metabolic function and overground speed were observed following high- versus low-intensity training, with no effects of intervention order. Moderate to high correlations were observed between differences in walking speed or distances and differences in HRs or RPEs during high- versus low-intensity training. CONCLUSION: This pilot study provides the first evidence that the intensity of stepping practice may be an important determinant of LT outcomes in individuals with iSCI. Whether such training is feasible in larger patient populations and contributes to improved locomotor outcomes deserves further consideration.

Altered Sagittal- and Frontal-Plane Kinematics Following High-Intensity Stepping Training Versus Conventional Interventions in Subacute Stroke.

BACKGROUND: Common locomotor deficits observed in people poststroke include decreased speeds and abnormal kinematics, characterized by altered symmetry, reduced sagittal-plane joint excursions, and use of compensatory frontal-plane behaviors during the swing phase of gait. Conventional interventions utilized to mitigate these deficits often incorporate low-intensity, impairment-based or functional exercises focused on normalizing kinematics, although the efficacy of these strategies is unclear. Conversely, higher-intensity training protocols that provide only stepping practice and do not focus on kinematics have demonstrated gains in walking function, although minimal attention toward gait quality may be concerning and has not been assessed. OBJECTIVE: The present study evaluated changes in spatiotemporal and joint kinematics following experimental, high-intensity stepping training compared with conventional interventions. DESIGN: Kinematic data were combined from a randomized controlled trial comparing experimental and conventional training and from a pilot experimental training study. METHODS: Individuals with gait deficits 1 to 6 months poststroke received up to 40 sessions of either high-intensity stepping training in variable contexts or conventional lower-intensity interventions. Analyses focused on kinematic changes during graded treadmill testing before and following training. RESULTS: Significant improvements in speed, symmetry, and selected sagittal-plane kinematics favored experimental training over conventional training, although increases in compensatory strategies also were observed. Changes in many kinematic patterns were correlated with speed changes, and increased compensatory behaviors were associated with both stride length gains and baseline impairments. LIMITATIONS: Limitations include a small sample size and use of multiple statistical comparisons. CONCLUSIONS: Improved speeds and selected kinematics were observed following high-intensity training, although such training also resulted in increased use of compensatory strategies. Future studies should explore the consequences of utilizing these compensatory strategies despite the observed functional gains.