A framework for clinical utilization of robotic exoskeletons in rehabilitation.

Exoskeletons are externally worn motorized devices that assist with sit-to-stand and walking in individuals with motor and functional impairments. The Food & Drug Administration (FDA) has approved several of these technologies for clinical use however, there is limited evidence to guide optimal utilization in every day clinical practice. With the diversity of technologies & equipment available, it presents a challenge for clinicians to decide which device to use, when to initiate, how to implement these technologies with different patient presentations, and when to wean off the devices. Thus, we present a clinical utilization framework specific to exoskeletons with four aims.These aims are to assist with clinical decision making of when exoskeleton use is clinically indicated, identification of which device is most appropriate based on patient deficits and device characteristics, providing guidance on dosage parameters within a plan of care and guidance for reflection following utilization. This framework streamlines how clinicians can approach implementation through the synthesis of published evidence with appropriate clinical assessment & device selection to reflection for success and understanding of these innovative & complex technologies.

Muscle adaptations in acute SCI following overground exoskeleton + FES training: A pilot study.

Objective: To evaluate the combined effects of robotic exoskeleton and functional electrical stimulation (FES) training on muscle composition during over-ground gait training in persons with acute spinal cord injury (SCI). Design: Randomized crossover pilot study. Setting: Inpatient-rehabilitation Hospital. Participants: Six individuals with acute SCI. Intervention: Participants were randomized to either receive training with the Ekso® Bionics exoskeleton combined with FES in addition to standard-of-care or standard-of-care alone. Outcome measures: The main outcome measures for the study were quantified using magnetic resonance imaging (MRI), specifically, lower extremity muscle volume and intramuscular adipose tissue (IMAT). Static balance and fall risk were assessed using the Berg Balance Scale. Results: Significant improvements were observed in muscle volume in the exoskeleton intervention group when compared to only standard-of-care (p < 0.001). There was no significant difference between the groups in IMAT even though the intervention group saw a reduction in IMAT that trended towards statistical significance (p = 0.07). Static balance improved in both groups, with greater improvements seen in the intervention group. Conclusions: Early intervention with robotic exoskeleton may contribute to improved muscle function measured using MRI in individuals with acute SCI.

Soft robotic exosuit augmented high intensity gait training on stroke survivors: a pilot study.

BACKGROUND: Stroke is a leading cause of serious gait impairments and restoring walking ability is a major goal of physical therapy interventions. Soft robotic exosuits are portable, lightweight, and unobtrusive assistive devices designed to improve the mobility of post-stroke individuals through facilitation of more natural paretic limb function during walking training. However, it is unknown whether long-term gait training using soft robotic exosuits will clinically impact gait function and quality of movement post-stroke. OBJECTIVE: The objective of this pilot study was to examine the therapeutic effects of soft robotic exosuit-augmented gait training on clinical and biomechanical gait outcomes in chronic post-stroke individuals. METHODS: Five post-stroke individuals received high intensity gait training augmented with a soft robotic exosuit, delivered in 18 sessions over 6-8 weeks. Performance based clinical outcomes and biomechanical gait quality parameters were measured at baseline, midpoint, and completion. RESULTS: Clinically meaningful improvements were observed in walking speed ([Formula: see text] < 0.05) and endurance ([Formula: see text] < 0.01) together with other traditional gait related outcomes. The gait quality measures including hip ([Formula: see text] < 0.01) and knee ([Formula: see text] < 0.05) flexion/extension exhibited an increase in range of motion in a symmetric manner ([Formula: see text] < 0.05). We also observed an increase in bilateral ankle angular velocities ([Formula: see text] < 0.05), suggesting biomechanical improvements in walking function. CONCLUSIONS: The results in this study offer preliminary evidence that a soft robotic exosuit can be a useful tool to augment high intensity gait training in a clinical setting. This study justifies more expanded research on soft exosuit technology with a larger post-stroke population for more reliable generalization. Trial registration This study is registered with ClinicalTrials.gov (ID: NCT04251091).

Controller synthesis and clinical exploration of wearable gyroscopic actuators to support human balance.

Gyroscopic actuators are appealing for wearable applications due to their ability to provide overground balance support without obstructing the legs. Multiple wearable robots using this actuation principle have been proposed, but none has yet been evaluated with humans. Here we use the GyBAR, a backpack-like prototype portable robot, to investigate the hypothesis that the balance of both healthy and chronic stroke subjects can be augmented through moments applied to the upper body. We quantified balance performance in terms of each participant's ability to walk or remain standing on a narrow support surface oriented to challenge stability in either the frontal or the sagittal plane. By comparing candidate balance controllers, it was found that effective assistance did not require regulation to a reference posture. A rotational viscous field increased the distance healthy participants could walk along a 30mm-wide beam by a factor of 2.0, compared to when the GyBAR was worn but inactive. The same controller enabled individuals with chronic stroke to remain standing for a factor of 2.5 longer on a narrow block. Due to its wearability and versatility of control, the GyBAR could enable new therapy interventions for training and rehabilitation.

Stride management assist exoskeleton vs functional gait training in stroke: A randomized trial.

OBJECTIVE: To test the hypothesis that gait training with a hip-assistive robotic exoskeleton improves clinical outcomes and strengthens the descending corticospinal drive to the lower limb muscles in persons with chronic stroke. METHODS: Fifty participants completed the randomized, single-blind, parallel study. Participants received over-ground gait training with the Honda Stride Management Assist (SMA) exoskeleton or intensity-matched functional gait training, delivered in 18 sessions over 6-8 weeks. Performance-based and self-reported clinical outcomes were measured at baseline, midpoint, and completion, and at a 3-month follow-up. Corticomotor excitability (CME) of 3 bilateral leg muscles was measured using transcranial magnetic stimulation. RESULTS: The primary outcome, walking speed, improved for the SMA group by completion of the program (0.24 ± 0.14 m/s difference, p < 0.001). Compared to the functional group, SMA users had greater improvement in walking endurance (46.0% ± 27.4% vs 35.7% ± 20.8%, p = 0.033), took more steps during therapy days (4,366 ± 2,426 vs 3,028 ± 1,510; p = 0.013), and demonstrated larger changes in CME of the paretic rectus femoris (178% ± 75% vs 33% ± 32%, p = 0.010). Participants with hemorrhagic stroke demonstrated greater improvement in balance when using the SMA (24.7% ± 20% vs 6.8% ± 6.7%, p = 0.029). CONCLUSIONS: Gait training with the SMA improved walking speed in persons with chronic stroke, and may promote greater walking endurance, balance, and CME than functional gait training. CLINICALTRIALSGOV IDENTIFIER: NCT01994395. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that gait training with a hip-assistive exoskeleton increases clinical outcomes and CME in persons with chronic stroke, but does not significantly improve walking speeds compared to intensity-matched functional gait training.