Effects of high-intensity gait training with and without soft robotic exosuits in people post-stroke: a development-of-concept pilot crossover trial.

INTRODUCTION: High-intensity gait training is widely recognized as an effective rehabilitation approach after stroke. Soft robotic exosuits that enhance post-stroke gait mechanics have the potential to improve the rehabilitative outcomes achieved by high-intensity gait training. The objective of this development-of-concept pilot crossover study was to evaluate the outcomes achieved by high-intensity gait training with versus without soft robotic exosuits. METHODS: In this 2-arm pilot crossover study, four individuals post-stroke completed twelve visits of speed-based, high-intensity gait training: six consecutive visits of Robotic Exosuit Augmented Locomotion (REAL) gait training and six consecutive visits without the exosuit (CONTROL). The intervention arms were counterbalanced across study participants and separated by 6 + weeks of washout. Walking function was evaluated before and after each intervention using 6-minute walk test (6MWT) distance and 10-m walk test (10mWT) speed. Moreover, 10mWT speeds were evaluated before each training visit, with the time-course of change in walking speed computed for each intervention arm. For each participant, changes in each outcome were compared to minimal clinically-important difference (MCID) thresholds. Secondary analyses focused on changes in propulsion mechanics and associated biomechanical metrics. RESULTS: Large between-group effects were observed for 6MWT distance (d = 1.41) and 10mWT speed (d = 1.14). REAL gait training resulted in an average pre-post change of 68 ± 27 m (p = 0.015) in 6MWT distance, compared to a pre-post change of 30 ± 16 m (p = 0.035) after CONTROL gait training. Similarly, REAL training resulted in a pre-post change of 0.08 ± 0.03 m/s (p = 0.012) in 10mWT speed, compared to a pre-post change of 0.01 ± 06 m/s (p = 0.76) after CONTROL. For both outcomes, 3 of 4 (75%) study participants surpassed MCIDs after REAL training, whereas 1 of 4 (25%) surpassed MCIDs after CONTROL training. Across the training visits, REAL training resulted in a 1.67 faster rate of improvement in walking speed. Similar patterns of improvement were observed for the secondary gait biomechanical outcomes, with REAL training resulting in significantly improved paretic propulsion for 3 of 4 study participants (p < 0.05) compared to 1 of 4 after CONTROL. CONCLUSION: Soft robotic exosuits have the potential to enhance the rehabilitative outcomes produced by high-intensity gait training after stroke. Findings of this development-of-concept pilot crossover trial motivate continued development and study of the REAL gait training program.

Effects of a soft robotic exosuit on the quality and speed of overground walking depends on walking ability after stroke.

BACKGROUND: Soft robotic exosuits can provide partial dorsiflexor and plantarflexor support in parallel with paretic muscles to improve poststroke walking capacity. Previous results indicate that baseline walking ability may impact a user's ability to leverage the exosuit assistance, while the effects on continuous walking, walking stability, and muscle slacking have not been evaluated. Here we evaluated the effects of a portable ankle exosuit during continuous comfortable overground walking in 19 individuals with chronic hemiparesis. We also compared two speed-based subgroups (threshold: 0.93 m/s) to address poststroke heterogeneity. METHODS: We refined a previously developed portable lightweight soft exosuit to support continuous overground walking. We compared five minutes of continuous walking in a laboratory with the exosuit to walking without the exosuit in terms of ground clearance, foot landing and propulsion, as well as the energy cost of transport, walking stability and plantarflexor muscle slacking. RESULTS: Exosuit assistance was associated with improvements in the targeted gait impairments: 22% increase in ground clearance during swing, 5° increase in foot-to-floor angle at initial contact, and 22% increase in the center-of-mass propulsion during push-off. The improvements in propulsion and foot landing contributed to a 6.7% (0.04 m/s) increase in walking speed (R2 = 0.82). This enhancement in gait function was achieved without deterioration in muscle effort, stability or cost of transport. Subgroup analyses revealed that all individuals profited from ground clearance support, but slower individuals leveraged plantarflexor assistance to improve propulsion by 35% to walk 13% faster, while faster individuals did not change either. CONCLUSIONS: The immediate restorative benefits of the exosuit presented here underline its promise for rehabilitative gait training in poststroke individuals.

Autonomous Control of Music to Retrain Walking After Stroke.

BACKGROUND: Post-stroke care guidelines highlight continued rehabilitation as essential; however, many stroke survivors cannot participate in outpatient rehabilitation. Technological advances in wearable sensing, treatment algorithms, and care delivery interfaces have created new opportunities for high-efficacy rehabilitation interventions to be delivered autonomously in any setting (ie, clinic, community, or home). METHODS: We developed an autonomous rehabilitation system that combines the closed-loop control of music with real-time gait analysis to fully automate patient-tailored walking rehabilitation. Specifically, the mechanism-of-action of auditory-motor entrainment is applied to induce targeted changes in the post-stroke gait pattern by way of targeted changes in music. Using speed-controlled biomechanical and physiological assessments, we evaluate in 10 individuals with chronic post-stroke hemiparesis the effects of a fully-automated gait training session on gait asymmetry and the energetic cost of walking. RESULTS: Post-treatment reductions in step time (Δ: -12 ± 26%, P = .027), stance time (Δ: -22 ± 10%, P = .004), and swing time (Δ: -15 ± 10%, P = .006) asymmetries were observed together with a 9 ± 5% reduction (P = .027) in the energetic cost of walking. Changes in the energetic cost of walking were highly dependent on the degree of baseline energetic impairment (r =- .90, P < .001). Among the 7 individuals with a baseline energetic cost of walking larger than the normative value of healthy older adults, a 13 ± 4% reduction was observed after training. CONCLUSIONS: The closed-loop control of music can fully automate walking rehabilitation that markedly improves walking after stroke. Autonomous rehabilitation delivery systems that can safely provide high-efficacy rehabilitation in any setting have the potential to alleviate access-related care gaps and improve long-term outcomes after stroke.

Targeting Paretic Propulsion and Walking Speed With a Soft Robotic Exosuit: A Consideration-of-Concept Trial.

Background: Soft robotic exosuits can facilitate immediate increases in short- and long-distance walking speeds in people with post-stroke hemiparesis. We sought to assess the feasibility and rehabilitative potential of applying propulsion-augmenting exosuits as part of an individualized and progressive training program to retrain faster walking and the underlying propulsive strategy. Methods: A 54-yr old male with chronic hemiparesis completed five daily sessions of Robotic Exosuit Augmented Locomotion (REAL) gait training. REAL training consists of high-intensity, task-specific, and progressively challenging walking practice augmented by a soft robotic exosuit and is designed to facilitate faster walking by way of increased paretic propulsion. Repeated baseline assessments of comfortable walking speed over a 2-year period provided a stable baseline from which the effects of REAL training could be elucidated. Additional outcomes included paretic propulsion, maximum walking speed, and 6-minute walk test distance. Results: Comfortable walking speed was stable at 0.96 m/s prior to training and increased by 0.30 m/s after training. Clinically meaningful increases in maximum walking speed (Δ: 0.30 m/s) and 6-minute walk test distance (Δ: 59 m) were similarly observed. Improvements in paretic peak propulsion (Δ: 2.80 %BW), propulsive power (Δ: 0.41 W/kg), and trailing limb angle (Δ: 6.2 degrees) were observed at comfortable walking speed (p's < 0.05). Likewise, improvements in paretic peak propulsion (Δ: 4.63 %BW) and trailing limb angle (Δ: 4.30 degrees) were observed at maximum walking speed (p's < 0.05). Conclusions: The REAL training program is feasible to implement after stroke and capable of facilitating rapid and meaningful improvements in paretic propulsion, walking speed, and walking distance.

A Music-Based Digital Therapeutic: Proof-of-Concept Automation of a Progressive and Individualized Rhythm-Based Walking Training Program After Stroke.

BACKGROUND: The rhythm of music can entrain neurons in motor cortex by way of direct connections between auditory and motor brain regions. OBJECTIVE: We sought to automate an individualized and progressive music-based, walking rehabilitation program using real-time sensor data in combination with decision algorithms. METHODS: A music-based digital therapeutic was developed to maintain high sound quality while modulating, in real-time, the tempo (ie, beats per minute, or bpm) of music based on a user's ability to entrain to the tempo and progress to faster walking cadences in-sync with the progression of the tempo. Eleven individuals with chronic hemiparesis completed one automated 30-minute training visit. Seven returned for 2 additional visits. Safety, feasibility, and rehabilitative potential (ie, changes in walking speed relative to clinically meaningful change scores) were evaluated. RESULTS: A single, fully automated training visit resulted in increased usual (∆ 0.085 ± 0.027 m/s, P = .011) and fast (∆ 0.093 ± 0.032 m/s, P = .016) walking speeds. The 7 participants who completed additional training visits increased their usual walking speed by 0.12 ± 0.03 m/s after only 3 days of training. Changes in walking speed were highly related to changes in walking cadence (R2 > 0.70). No trips or falls were noted during training, all users reported that the device helped them walk faster, and 70% indicated that they would use it most or all of the time at home. CONCLUSIONS: In this proof-of-concept study, we show that a sensor-automated, progressive, and individualized rhythmic locomotor training program can be implemented safely and effectively to train walking speed after stroke. Music-based digital therapeutics have the potential to facilitate salient, community-based rehabilitation.