Mobile Measures is a mobile app that offers physical therapists and other providers access to outcome performance measures that assess fall risk, risk of hospitalization, frailty, and more. The app guides users to the best test for more than 40 different patient populations, calculates scores automatically, offers immediate interpretation of the results using the most up-to-date research, and shares results via email to enhance documentation and improve communication. With Mobile Measures, users can visualize the impact of their patient’s condition, track progress, and determine the effectiveness of treatments directly at the point of care, while improving efficiency. Mobile Measures is available on the App Store and Google Play. A free trial is available.
Virtual reality video games, activity monitors, and handheld computer devices can help people stand as well as walk, the largest trial worldwide into the effects of digital devices in rehabilitation has found. The study was undertaken at hospitals in Sydney and Adelaide, Australia, and had 300 participants ranging from 18 to 101 years old. Those who exercised using digital devices in addition to their usual rehabilitation were found to have better mobility (walking, standing up, and balance) after 3 weeks and after 6 months than those who just completed their usual rehabilitation. The results were published in PLOS Medicine.
Trial participants were recovering from strokes, brain injuries, falls, and fractures. Participants used on average 4 different devices while in hospital and 2 different devices when at home. Fitbits were the most used digital device but also tested were a suite of devices like Xbox, Wii, and iPads, making the exercises more interactive and enabling remote connection between patients and their physical therapists. Having a selection meant the physical therapist could tailor the choice of devices to meet the patient’s mobility problems while considering patient preferences.
Lead author Leanne Hassett, PhD, from the Faculty of Medicine and Health at the University of Sydney, said benefits reported by patients using the digital devices in rehabilitation included variety, fun, feedback about performance, cognitive challenge, that they enabled additional exercise, and the potential to use the devices with others, such as family, therapists, and other patients. “These benefits meant patients were more likely to continue their therapy when and where it suited them, with the assistance of digital healthcare,” she said.
Participants reported doing more walking at 6 months, meaning their rehabilitation was improved, but this was not detected in the physical activity measure (time spent upright) generally. In the younger age group, the devices also increased daily step count. Distinctions between physical activity were made through measurements with an activPAL, a small device attached to the thigh that records how much time is spent in different positions (sitting, standing, lying) as well as number of steps taken each day.
This study used research physical therapists to deliver the study; the next step will be to trial the approach in clinical practice by incorporating it into the work of physical therapists.
The majority of participants in a multi-center clinical study of the ReStore Soft Exo-Suit for the rehabilitation of individuals with lower limb disability due to stroke achieved meaningful walking speed improvements, according to ReWalk Robotics Ltd, in a media release.
The study examined patient safety and explored functional walking outcomes in stroke survivors who completed a series of gait training sessions with the ReStore device.
This research was conducted primarily to support the Company’s successful application to the U.S. Food and Drug Administration (FDA) for clearance of the ReStore Exo-Suit, which was issued in June 2019. The company also received CE Marking for the device in May 2019.
Spaulding Rehabilitation Hospital in Boston, in partnership with Boston University College of Health and Rehabilitation Sciences: Sargent College;
MossRehab Stroke and Neurological Disease Center in Elkins Park, Pa;
TIRR Memorial Hermann in Houston; and
Kessler Foundation in West Orange, NJ.
“This multi-site clinical trial of the safety and feasibility of the ReStore Exo-Suit is an important milestone in the field of rehabilitation technology,” Lou Awad, PT, DPT, PhD, Director of Boston University’s Neuromotor Recovery Laboratory and the site investigator at Spaulding Rehabilitation Hospital for this study, says in the release.
“Physical therapists have historically relied on passive assistive devices to help patients with post-stroke hemiparesis walk safely. As an active assistive device, the ReStore soft robotic exo-suit offers new opportunities to retrain walking after stroke.”
Thirty-six study participants with hemiplegia due to stroke each completed seven total study visits with the ReStore Exo-Suit. In addition to establishing device safety, which was the primary outcome for the study, several exploratory outcome measures were investigated, including a pre- and post-assessment of walking speeds, in which 64% of participants increased their unassisted walking speed by a clinically meaningful margin, the release continues.
“We are thrilled to see the results from the ReStore clinical trial being published in a joint paper authored by the primary investigators from all five of our highly regarded study sites,” says Kathleen O’Donnell, Director of Product Management and Strategy at ReWalk Robotics, headquartered in Marlborough, Mass.
“This work summarizes the first results from the largest soft exo-suit trial to date, and the positive findings in terms of safety and improved walking speeds showcase the potential of this technology to dramatically impact patient outcomes post stroke,” she adds.
The first-of-its-kind ReStore Exo-Suit was unveiled in 2017 and was designed to be a versatile, cost-effective gait therapy solution to train for improved gait by providing coordinated plantarflexion and dorsiflexion assistance to a patient’s impaired foot and ankle, according to the company.
Ankle spasticity is a frequent phenomenon that limits functionality in poststroke patients.
Our aim was to determine if there was decreased spasticity in the ankle plantar flex (PF) muscles in the plegic lower extremity (LE) and improvement of gait function in stroke patients after traditional rehabilitation (TR) in combination with virtual reality with reinforced feedback, which is termed “reinforced feedback virtual environment” (RFVE).
The evaluation, before and after treatment, of 10 hemiparetic patients was performed using the Modified Ashworth Scale (MAS), Functional Ambulatory Category (FAC), and Functional Independence Measure (FIM). The intervention consisted of 1 hour/day of TR plus 1 hour/day of RFVE (5 days/week for 3 weeks; 15 sessions in total).
The MAS and FAC reached statistical significance (P < 0.05). The changes in the FIM did not reach statistical significance (P=0.066). The analysis between the ischemic and haemorrhagic patients showed significant differences in favour of the haemorrhagic group in the FIM scale. A significant correlation between the FAC and the months after the stroke was established (P=−0.711). Indeed, patients who most increased their score on the FAC at the end of treatment were those who started the treatment earliest after stroke.
The combined treatment of TR and RFVE showed encouraging results regarding the reduction of spasticity and improvement of gait function. An early commencement of the treatment seems to be ideal, and future research should increase the sample size and assessment tools.
Stroke patients suffer several deficits that affect (mildly to severely) the cognitive, psychological, or motor areas of the brain, at the expense of their quality of life . Although rehabilitation techniques do not only act on the motor deficits , the effects associated with the interruptions of the corticospinal tract, as well as the subsequent adaptive changes, commonly require specific interventions. Among them, the most important changes are muscle weakness, loss of dexterity, cocontraction, and increased tone and abnormal postures .
Hemiparesis is the most common problem in poststroke patients, and its severity correlates with the functional capabilities of the individual , being that impairment of gait function is one of the most important limitations. Furthermore, weakness of the ankle muscles caused by injury to supraspinal centres and spasticity are the most frequent phenomena that limit functionality . The degree of spasticity of the affected ankle plantar flex (PF) muscles primarily influences gait asymmetry , which is, in addition to depression, another independent factor for predicting falls in ambulatory stroke patients . Physiological changes in the paretic muscles, passive or active restraint of agonist activation, and abnormal muscle activation patterns (coactivation of the opposing lower extremity (LE)) have been shown to occur after a stroke and can lead to joint stiffness (foot deformities are present in 30% of stroke patients) , deficits in postural stabilization, and reduced muscle force generation . To enhance this postural stability during gait, it seems that poststroke patients with impaired balance and paretic ankle muscle weakness use a compensation strategy of increased ankle muscle coactivation on the paretic side .
Scientific evidence shows that the use of mixed techniques with different physiotherapy approaches under very broad classifications (i.e., neurophysiological, motor learning, and orthopaedic) provides significantly better results regarding recovery of autonomy, postural control, and recovery of LE in the hemiparetic patient (HP) as compared to no treatment or the use of placebo . Within the latter techniques, we may emphasize the relearning of motor-oriented tasks , as well as other approaches based on new technologies (e.g., treadmill , robotics [14–16], and functional electrical stimulation (FES) ), which are often used as additional treatments to traditional rehabilitation (TR). However, some of these emerging therapies, such as vibratory platforms , have not been shown yet to produce as positive results as the prior ones. Thus, obtaining better results with mixed and more intensive rehabilitation treatment has been demonstrated [19, 20]. Therefore, we propose to add the use of virtual reality (VR) techniques to TR to optimize results. We can use the label “VR-based therapy” because it acknowledges the VR system as the tool being used by the clinician in therapy, not as the therapy itself. It is essential to transfer the obtained gains in VR-based therapy to better functioning in the real world . In this way, the intersection of a promising technological tool with the skills of confident and competent clinicians will more likely yield high-quality evidence and enhanced outcomes for physical rehabilitation patients .
The application of VR to motor recovery of the hemiparetic LE (HLE) has been addressed by several authors in the last decade [23–28], obtaining satisfactory results, in general terms, in the increase of walking speed [22, 24, 25], cortical reorganization, balance, and kinetic-kinematic parameters. Other authors have reported improvements in the balance of patients treated with nonimmersive VR systems based on video games, using specific software and with the guidance of a therapist . A recent study showed that VR-based eccentric training using a slow velocity is effective for improving LE muscle activity to the gastrocnemius muscle and balance in stroke ; however, the spasticity of PF muscles was not analysed in any of these studies.
Virtual reality acts as an augmented environment where feedback can be delivered in the form of enhanced information about knowledge of results and knowledge of performance (KP) . There are systems that use this KP through the representation of trajectories during the execution of the movement, as well as visualizing these once performed, to visually check the amount of deviation from the path proposed by the physiotherapist. Several studies demonstrated that this treatment enriched by reinforced feedback in a virtual environment (RFVE) may be more effective than TR to improve the motor function of the upper limb after stroke [31, 32]. In our study, the use of a VR-based system, together with a motion capture tool, allowed us to modify the artificial environment with which the patient could interact, exploiting some mechanisms of motor learning [33, 34], thus allowing greater flexibility and effective improvement in task learning. This system has been highly successful in the functional recovery of the hemiparetic upper extremity [31, 33–36], but its combined effect with TR on the LE has not yet reported conclusive data . The continuous supply of feedback during voluntary movement makes it possible to continuously adjust contractile activity , thus mitigating increments in spasticity and cocontraction processes of the patient. These settings are of great significance in motor control, and certain variables (such as the speed of the movement) can be controlled, having a direct influence on spasticity. In this line, the aim of this study is to determine if there is a decrease in the spasticity of the PF muscles and improved gait function, following a program that includes the combination of TR and VR with reinforced feedback, which is called “reinforced feedback virtual environment” (RFVE).
Moreover, as a complementary aim, we analysed the modulatory effects of demographic and clinical factors on the recovery of patients treated with TR and VR. The analysis of the influence of these modulatory variables was focused on better highlighting what type of patients would benefit most from the combined treatment of TR and VR. Particularly, we looked into the effects of age and time elapsed from the moment the stroke occurs until the patient starts neurorehabilitation. As shown in various studies, a better outcome for treatment can be expected for younger patients and for those who start the treatment earlier . Also, comparisons were made between patients with an ischemic and haemorrhagic stroke, since differences in their recovery prognostic have been reported elsewhere, with better outcomes for the latter group .[…]
Purpose: This study aimed to determine the inter- and intra-rater reliability of and minimal detectable changes (MDCs) at the 95% confidence interval in gait performance tests in patients with chronic hemiplegic stroke who can walk independently.
Materials and Methods: Thirty patients with chronic hemiplegic stroke (24 men, 6 women, mean age 62.5 ± 11.6 years) were enrolled. Physical therapists (mean clinical experience: 9.1 ± 9.3 years) performed the timed up and go test (TUG), 10-m walk test (10MWT), and 6-min walk test (6MWT) 1 day apart. Reliability was evaluated using the intraclass correlation coefficient (ICC) and Bland–Altman analysis.
Results: The ICC was ≥0.9 for all tests, and no systematic bias was found. MDC at the 95% confidence interval was 1.9 s for the TUG, 0.16 m/s for the 10MWT, and 28.4 m for the 6MWT.
Discussion: We demonstrated excellent intra- and inter-rater reliability of all tests. These results suggest that gait performance tests are reliable.
Conclusion: These commonly used gait performance tests demonstrated high reliability and can be recommended to evaluate clinically meaningful improvements in patients with chronic hemiplegic stroke who can walk independently.
A trained Pilates professional in a fully equipped studio can help your patient make significant improvement in strength and flexibility by addressing postural habits and alignment problems.
By Marianne Adams, MA, MFA
Joseph Hubertus Pilates began development of his method – a body–mind approach to exercise –in the early 1920s. As a child, Pilates suffered from asthma, rickets, and rheumatic fever. His early efforts toward self-healing explored a multilayered approach to building strength, body awareness, breath control, and increasing flexibility, all in a balanced way.1 Early in his career, he also worked as a boxer, circus performer, and self-defense trainer.
Because Pilates’s perspectives were so varied, his approach makes Pilates particularly effective as a rehabilitative tool – recognizing the role that kinesthetic awareness, or mindfulness, plays in efficient physical (and mental) repatterning.2 The Pilates method was designed to create harmony between body and mind by combining aspects of mental focus and breath awareness with the physicality of gymnastics and other sports.3
Between the 1920s and 1970s, an increasing number of dancers, circus performers, and athletes worked with Pilates and had a strong impact on the development of his method. To develop his method, Pilates studied, and drew from, Eastern and Western practices, including Yoga, Zen meditation, and ancient forms of Greek and Roman exercise. His original name for the Pilates method was “Contrology,” which he defined this way4:
Contrology is the complete coordination of body, mind and spirit. Through Contrology you first purposefully acquire complete control of your own body and then, through proper repetition of its exercises, you gradually and progressively acquire that natural rhythm and coordination associated with all your mental and subconscious activities…. Contrology develops the body uniformly, corrects wrong postures, restores physical vitality, invigorates the mind, and elevates the spirit.
Pilates’s Method Today
Although there are many different approaches to the Pilates method, the style that adheres most closely to Pilates’ original work is “Classical,” or “Authentic,” Pilates. In this tradition, the work is typically taught one-on-one, using equipment that is very similar to the equipment that Pilates developed in the early part of the 20th Century. Pilates created more than a dozen pieces of apparatus – using springs, pulleys, and arcs for resistance or support – to improve fitness on 3 levels: mind, body, and spirit.5
Although many clients might have been exposed to Pilates mat exercises, the full potential of the method is enhanced by experiencing the method in a fully equipped studio. Each lesson is individualized, and all teachers certified in the Classical approach have completed a rigorous training program more than 600 hours long, including comprehensive examinations.
Pilates created a repertoire of more than 500 exercises for supine, standing, and seated positions. Whereas one apparatus adds challenge, a similar exercise on another apparatus will give a beginner, or rehabilitative client, a needed simplification.2 Although the examples provided in this article focus on exercises for strengthening, awareness of alignment, and increasing range of motion in the lower leg, the fundamental philosophical approach of the method is to “work” the body as a unified whole.
An important aspect of the Pilates method is to treat the whole body as a system; that is, clients who are seeking rehabilitation for a specific body condition are instructed to initiate and engage from the core of the trunk musculature, generally considered to include the transversus abdominis, oblique, rectus abdominis, gluteal, and adductor muscles. Pilates called this core the “powerhouse.” The approach of working mindfully with the breath is central to his method, as is a limited number of repetitions with each exercise, to foster the sense of mind–body kinesthesia.
Footwork (Supine) Using the “Reformer”
This is the first piece of apparatus that Pilates invented, while interned as a German prisoner of war in England, during World War I. He made his early prototype from a hospital bed, using springs and pulleys, to help his platoon recover and heal from their injuries. The Reformer comprises a frame with springs that attach to a carriage. As the carriage rolls horizontally on tracks, the springs add non-weight-bearing resistance to each exercise.
Because most exercises on the Reformer, are performed supine, this is the typical starting place for most clients. Typically, the instructor stands at the foot of the Reformer as this position offers a trained instructor a wealth of information on full body alignment, muscular habits of tension, breath patterns, etc., as the client begins to move.
The initial series of exercises on the Reformer is called “footwork” (Figure 1). The client lies supine on the carriage, knees bent, with the metatarsal pads of the feet at the center of the foot bar, heels together, toes in external rotation at 30° to 45°. As the client straightens their legs, they push the carriage away from the foot bar; the springs add resistance. The spring action must be controlled on the return as the carriage glides back into the stop, or stable, position.
By pulling the transverse abdominal muscles in and upward, the legs push against the bar to straighten and, keeping the legs straight (Figure 2); the heels then lower and lift, working to increase strength and range of motion in the toes and ankle joint. For clients in the active rehab phase of an ankle or knee injury, or after hip replacement, the spring resistance typically is adjusted downward, from 4 to 2 springs.
Footwork is a multipart exercise, repeated in several foot positions, using the toes (Figure 1), arches (Figure 3), and heels (Figure 4) and a tendon stretch (Figure 5).
Footwork Seated in the “Wunda Chair”
Also known as the “magic chair,” the Wunda Chair (Figure 6) was developed for Pilates’s advanced clients who wanted a challenging workout in their home. The Wunda Chair comprises a stationary seat and a foot pedal; resistance varies with differing spring settings. Beginners will find many basic exercises on the Wunda Chair that increase strength, awareness of alignment, and balance. A client must be able to engage their abdominal core and balance while seated on a backless chair.
To complete the tendon stretch on the Wunda Chair (Figure 7), the client stands, with toes on the pedal in forward spinal flexion, as they lower and lift the heels by engaging the core muscles of the powerhouse. This is done on 2 legs simultaneously or in a right–left–right or left–right–left alternating pattern, as needed for rehabilitation.
In general, the Wunda Chair is good for working the weak–strong–weak sides of the body. It is important to realize that, although a client might present, for example, “a bad ankle,” any injury is rarely so isolated. Particularly when working with clients in rehabilitation, an instructor who begins to look closely will see that the presenting ankle problem is often linked to other patterns of dysfunctional alignment. Injury in one particular place will often be related to weakness or overuse in another area of the body.
This is the real beauty of the Wunda Chair: After close examination, an instructor might realize that, although a client needs to do right–left–right repetitions of the tendon stretch, they in fact need a left–right–left exercise pattern for the hips and a right–left–right pattern for exercises to strengthen or stretch the quadratus muscles.
Footwork (Standing) With the “Foot Corrector”
This apparatus can help identify and solve problems in foot and ankle standing alignment (Figure 8). The device is also helpful for rehabilitation after lower-leg injury.
The Foot Corrector comprises a brass foot plate, 2 vertical springs, and a perpendicular cross-plate that moves downward as the springs are compressed. It is often used for dancers or climbers, who need articulate foot strength and acute balance sensitivity. Because postural alignment needs to be maintained (keeping iliac hip pointers even), careful placement of the apparatus in relation to the standing leg and a watchful eye by the instructor are needed for feedback (Figures 9-11).
Rarely used, the toe spacer (Figure 12) is a small but beneficial piece of Joseph Pilates’ inventive repertoire.
Multiple Benefits Using Multiple Techniques
These are only a few Pilates footwork exercises. Many others, on other equipment, are performed in a typical Classical lesson to work the body as a unified system. Together, the apparatus system offers a great deal of flexibility for clients with varied needs. For example, clients with less mobility might start on the “Trapeze Table” (also called the “Cadillac”), which can be described as a massage table with a canopy frame. This apparatus allows a client to begin their exercises that provide spring resistance in a stable, supine position.
When Pilates is practiced with a comprehensively trained professional, in a fully equipped studio, efficient progress can be made by increasing awareness of postural habits and alignment issues. For many clients, simply coordinating the conscious use of breath with movement initiation from the core eases pain and can improve daily quality of life. Consistent Pilates training can enhance alignment awareness, physical efficiency, and core control.
Marianne Adams, MA (Clinical Psychology), MFA (Choreography and Performance), is Professor of Dance Studies,, Department of Theatre and Dance, Appalachian State University, Boone, North Carolina, where she is a member of the graduate faculty of Appalachian for Expressive Arts and Bodywork. Ms. Adams has also worked in therapeutic movement in mental health settings.
*Photographs provided by the author. Not for reuse without permission. Model: Rebecca Quinn.
Adams M, Caldwell K, Atkins L, Quin R. Pilates and mindfulness: a qualitative study. Journal of Dance Education. 2012;12(4):123-130.
Adams M, Quin R. The Pilates Teacher Training Manual. Boone, NC: The Hubbard Center, Appalachian State University; 2018.
Ungaro A. Pilates: Body in Motion. London, England: Dorling Kindersley Publishing, Inc; 2002.
Gallagher S, Kryzanowska R, eds. The Complete Writings of Joseph H. Pilates: Your Health and Return to Life Through Contrology. Philadelphia, PA: Bainbridge Books; 2000.
Caldwell K, Adams M, Quin R, Harrison M, Greeson J. Pilates, mindfulness and somatic education. J Dance Somat Pract. 2013; 5(2):141-153.
Ekso Bionics Holdings Inc announces it has received 501(k) clearance from the U.S. Food and Drug Administration (FDA) to market its EksoNR robotic exoskeleton for use with patients with acquired brain injury (ABI).
EksoNR is reportedly the first exoskeleton device to receive FDA clearance for rehabilitation use with ABI. It was previously cleared by the FDA for stroke and spinal cord injury rehabilitation in 2016.
ABI is comprised of both traumatic (TBI) and non-traumatic (n-TBI) brain injury causes. TBI includes severe head injuries and concussions, while n-TBI includes a broader subset of conditions, such as stroke, aneurysms, brain tumors, anoxia, degenerative and metabolic conditions, infections, and surgical injuries, among others, according to a media release from Ekso Biokics.
“With the expanded indications to include the broad category of acquired brain injuries, the EksoNR has the potential to mobilize significantly more patients and improve patient recovery. Based on their experience with EksoNR, customers at leading rehabilitation centers have acknowledged the benefits our technology can offer during recovery from brain injuries. We are excited to see the device used more widely in neurorehabilitation.”
What if a wheelchair could sense collisions and dangerous drop offs before its user knew there were there? The world is about to find out.
New to the marketplace is Nashville, Tenn-based LUCI, whose premiere product, also named LUCI, is a hardware and software platform that uses sensor-fusion technologies to allow a power wheelchair to “see” its environment.
Once mounted onto a power wheelchair between the power base and the seat, LUCI aims to help users avoid collisions and dangerous drop-offs while maintaining personalized driving control. Through cloud-based capabilities, LUCI can also monitor and alert users and caregivers of low battery, possible tipping scenarios, and other important updates regarding the chair and the user.
“Wheelchair users were left behind when it comes to most innovative technology,” says Barry Dean, CEO and Founder of LUCI. Dean is also a Grammy-nominated songwriter, and his daughter Katherine, 19, has cerebral palsy and has used a wheelchair her whole life.
“We realized no one else was working on this problem in a meaningful way, so my brother Jered [Dean, CTO of LUCI] and I set out to create a solution for Katherine,” he says, in a media release.
“What started as a labor of love among family members has ultimately created a safer, more stable way for people with disabilities to navigate their world and stay connected to loved ones. Today, we’re excited to launch LUCI and continue collaborating with researchers, universities and other companies using our open platform to move the industry forward together,” he adds.
The LUCI team spent the past two and half years collaborating with clinical professionals and logging over 25,000 hours of user testing to develop an invention to help people with physical disabilities drive safely, precisely and independently. LUCI’s R&D efforts have already resulted in a total of 16 patents (eight pending).
“When we started tinkering with my niece Katherine’s chair, we had no idea where this journey would lead,” says Jered Dean, CTO, who has spent 2 decades in design and systems engineering, most recently serving as director of the Colorado School of Mines’s Capstone Design@Mines program.
“From developing advancements in millimeter-wave radar technology to collaborating with engineering leaders from Intel RealSense Technology Group to maximize the application of some of the world’s smartest cameras, I’m incredibly proud of the unprecedented work our team has accomplished to solve the challenges our customers face,” he continues, in the release.
“LUCI leverages Intel RealSense to map the world in a low-power, cost-effective way to make drop-off protection and collision avoidance possible, and we’re excited to be a part of this inspirational effort to deliver innovation that improves lives,” says Joel Hagberg, head of product management and marketing, Intel RealSense Group
LUCI’s technology combines stereovision, infrared, ultrasonic and radar sensors to offer users these critical features, per the release:
Collision avoidance: LUCI is designed to prevent wheelchair users from running into objects (walls, people, pets, furniture, etc) as they navigate their daily lives. It does this by smoothly helping to navigate the chair in coordination with user steering inputs based on obstacle detection in the driver’s surroundings.
Drop-off protection: It doesn’t take a large drop-off to tip a wheelchair (less than 3 inches in some cases). LUCI helps users avoid tipping by recognizing steps or drop-offs and smoothly helping the chair continue on a safer path.
Anti-tipping alert system: LUCI monitors the steepness of a ramp or the ground users are driving on and provides an audible alert if it becomes a tipping danger. In the event that a chair tips over, LUCI sounds an alarm and can be configured to quickly alert other individuals, such as a caregiver or loved one, of the exact location of the rider and the tipped chair.
Cloud-based communications and alerts: The MyLUCI portal allows users to view their data and share it with loved ones or clinicians. LUCI can be set up to alert others of specific events, such as the user’s location if their battery gets dangerously low. LUCI also now works with Hey Google and Amazon Alexa so users can interact with MyLUCI using their voice. MyLUCI portal is available as a mobile app for both iOS and Android phones, as well as for desktop with the Web Portal.
Secure health monitoring: LUCI users can choose to share their heart rate data with their team using either Google Fit or Apple HealthKit from day one.
Atypical walking in the months and years after stroke constrain community reintegration and reduce mobility, health, and quality of life. The ReWalk ReStore™ is a soft robotic exosuit designed to assist the propulsion and ground clearance subtasks of post-stroke walking by actively assisting paretic ankle plantarflexion and dorsiflexion. Previous proof-of-concept evaluations of the technology demonstrated improved gait mechanics and energetics and faster and farther walking in users with post-stroke hemiparesis. We sought to determine the safety, reliability, and feasibility of using the ReStore™ during post-stroke rehabilitation.
A multi-site clinical trial (NCT03499210) was conducted in preparation for an application to the United States Food and Drug Administration (FDA). The study included 44 users with post-stroke hemiparesis who completed up to 5 days of training with the ReStore™ on the treadmill and over ground. In addition to primary and secondary endpoints of safety and device reliability across all training activities, an exploratory evaluation of the effect of multiple exposures to using the device on users’ maximum walking speeds with and without the device was conducted prior to and following the five training visits.
All 44 study participants completed safety and reliability evaluations. Thirty-six study participants completed all five training days. No device-related falls or serious adverse events were reported. A low rate of device malfunctions was reported by clinician-operators. Regardless of their reliance on ancillary assistive devices, after only 5 days of walking practice with the device, study participants increased both their device-assisted (Δ: 0.10 ± 0.03 m/s) and unassisted (Δ: 0.07 ± 0.03 m/s) maximum walking speeds (P’s < 0.05).
When used under the direction of a licensed physical therapist, the ReStore™ soft exosuit is safe and reliable for use during post-stroke gait rehabilitation to provide targeted assistance of both paretic ankle plantarflexion and dorsiflexion during treadmill and overground walking.
Bipedal locomotion is characterized by alternating periods of single and double limb support, with ground clearance by the swing limb and propulsion by the trailing stance limb serving as crucial walking subtasks [1, 2]. Healthy individuals are able to generate an ankle dorsiflexion moment during each limb’s swing phase to lift the foot and facilitate ground clearance. They are also able to generate an ankle plantarflexion moment during each limb’s late stance phase to produce the propulsive force required to advance the limb and body . In contrast, post-stroke hemiparesis results in impaired paretic dorsiflexion and plantarflexion that, in turn, hinders ground clearance and propulsion [4,5,6,7,8] and, ultimately, necessitates compensatory walking strategies [9, 10] that make walking more effortful and unstable [11,12,13,14].
The ReWalk ReStore™ is a soft robotic exosuit designed to augment the paretic ankle’s ability to produce both dorsiflexor and plantarflexor moments during walking. In early proof-of-concept studies conducted with a research version of the device [15, 16], exosuits were shown to facilitate immediate increases in swing phase paretic ankle dorsiflexion by an average 5 degrees , the propulsion force generated by the paretic limb by an average 10% , and the positive center of mass (COM) power generated by the paretic limb during late stance phase by an average 22% . Together, these improvements in paretic limb function resulted in reduced propulsion asymmetry by 20%  and the asymmetry in positive COM power generated during late stance phase by 39% . Also observed were immediate reductions in hip hiking and circumduction compensations of over 20% , reductions in the energy cost of walking by an average 10% [17, 18], faster overground walking speeds by a median 0.14 m/s, and farther walking distances during the 6-min walk test by a median 32m .
Building on this foundational biomechanical, physiological, and clinical research, the objective of this multi-site clinical trial was to evaluate safety, feasibility, and reliability of using exosuits during post-stroke rehabilitation in preparation for a commercial clinical application to the United States Food and Drug Administration (FDA). In contrast to previous laboratory-based research that studied the immediate effects of exosuit prototypes on clinical, biomechanical, and physiological outcomes, this translational research sought to determine the safety of clinicians and patients with post-stroke hemiparesis using the commercially-adapted ReStore™ in clinical settings, the feasibility of clinician operators applying the ReStore™ during both treadmill and over ground gait training activities, and the reliability of the technology across multiple training visits. In addition to outcomes of safety, feasibility, and device reliability, an exploratory evaluation of the impact that multiple training visits with the device have on users’ maximum walking speeds, both with and without the device, was also included.
The ReStore™ is indicated for use by individuals with post-stroke hemiparesis undergoing stroke rehabilitation under the supervision of a licensed physical therapist. To assess the safety, device reliability, and clinical feasibility of using the ReStore™ during post-stroke gait rehabilitation, a multi-site trial was conducted. The trial included five clinical sites and 44 users with post-stroke hemiparesis. The study was approved by the Institutional Review Boards of Boston University, Spaulding Rehabilitation Hospital, The Shirley Ryan AbilityLab, TIRR Memorial Hermann Hospital, Kessler Rehabilitation Hospital, and Moss Rehabilitation Hospital. Written informed consent was secured for all participants.
Study inclusion and exclusion criteria
Study participant eligibility requirements consisted of: (i) one-sided ischemic or hemorrhagic stroke, (ii) > 2 weeks post-stroke, (iii) age > 18 years, (iv) height between 4′8″ and 6′7″, (v) weight < 264lbs, (vi) medical clearance, (vii) ability to ambulate at least 5 ft without an AFO and with no more than minimal contact assistance, (viii) ability to follow a 3-step command, (ix) ability to fit suit components, (x) no greater than 5 degrees of ankle plantar flexion contracture, and (xi) Modified Ashworth Scale for tone at 3 or less for ankle dorsiflexor and plantarflexor muscles. Exclusion criteria included: (i) severe aphasia limiting ability to express needs or discomfort verbally or non-verbally, (ii) serious co-morbidities that interfere with ability to participate, (iii) significant Peripheral Artery Disease, (iv) colostomy bag, (v) current pregnancy, (vi) uncontrolled hypertension, (vii) participation in any other clinical trial, (viii) open wounds or broken skin at device locations requiring medical management, (ix) urethane allergies, (x) and current DVT.
After screening and enrollment, study participants completed up to two walking evaluations and five device exposure visits. Each exposure visit consisted of up to 20 min of overground walking practice and 20 min of treadmill walking practice while receiving assistance from the device. The visit schedule consisted of a minimum of two visits per week, with the expectation of no more than 4 weeks between the pretraining and posttraining evaluations. Actual activities and durations were dependent on each study participant’s abilities as determined by the treating physical therapist as per their usual practices. The target level for plantarflexion assistance during all active walking with the ReStore™ was 25% of the user’s bodyweight [17, 19]. The target level for dorsiflexion assistance was the minimum needed for adequate ground clearance and heel strike, as determined visually by the physical therapist.
The exosuit consists of motors worn at the waist that generate mechanical forces that are transmitted by cables to attachment points located proximally on a functional textile worn around the calf and distally on a shoe insole (Fig. 1). The overall weight of the exosuit is approximately 5kgs, with the vast majority of the weight located proximally in the actuation pack worn at the waist. Each functional textile contains a detachable liner that can be washed. For users who require medio-lateral ankle support in addition to ankle plantarflexion and dorsiflexion assistance, an optional textile component that prevents ankle inversion without restricting dorsiflexion and plantarflexion can also be used. Inertial sensors that attach to a patient’s shoes measure gait events and automate the independent timing of the active ankle plantarflexion and dorsiflexion assistance provided by the ReStore™ as previously described . Load cell sensors located at the end of each cable are used to monitor the interaction between user and exosuit and ensure that the target level of assistance is achieved [16, 17]. A hand-held device with a graphical interface allows clinicians to monitor patients’ performance and select and progress, in real-time, the assistance parameters (Fig. 2).