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.
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).
The rehabilitation of cognitive and behavioral abnormalities in individuals with stroke is essential for promoting patient’s recovery and autonomy. The aim of our study is to evaluate the effects of robotic neurorehabilitation using Lokomat with and without VR on cognitive functioning and psychological well-being in stroke patients, as compared to traditional therapy.
Ninety stroke patients were included in this randomized controlled clinical trial. The patients were assigned to one of the three treatment groups, i.e. the Robotic Rehabilitation group undergoing robotic rehab with VR (RRG+VR), the Robotic Rehabilitation Group (RRG-VR) using robotics without VR, and the Conventional Rehabilitation group (CRG) submitted to conventional physiotherapy and cognitive treatment.
The analysis showed that either the robotic training (with and without VR) or the conventional rehabilitation led to significant improvements in the global cognitive functioning, mood, and executive functions, as well as in activities of daily living. However, only in the RRG+VR we observed a significant improvement in cognitive flexibility and shifting skills, selective attention/visual research, and quality of life, with regard to the perception of the mental and physical state.
Our study shows that robotic treatment, especially if associated with VR, may positively affect cognitive recovery and psychological well-being in patients with chronic stroke, thanks to the complex interation between movement and cognition.
A 56-yr-old woman with chronic stroke and gait dysfunction was recruited for this study. A lower-extremity constraint-induced movement therapy protocol was given consisting of 3.5 hrs/d of supervised intervention activities on 10 consecutive weekdays. Motor training was intensive and involved shaping. In addition, a group of behavior management strategies was used to induce further unsupervised practice and transference of motor skills from the laboratory to real-world situations. Changes in functional mobility, walking speed, balance, level of assistance, perceived quality of movement, and level of confidence while performing daily activities were assessed five times in both the baseline and intervention phases. The outcomes observed after the intervention were determined by calculating the difference between the average scores obtained in both phases. Changes in perceived quality of movement, level of confidence, level of assistance, and balance were observed.
Stroke is a neurologic disorder considered the first cause of disability worldwide due to motor, cognitive, and sensorial sequels. Balance dysfunctions in stroke survivors increase the risk of falls and physiotherapeutic rehabilitation is essential to reduce it. Virtual reality (VR) seems to be an alternative to conventional physiotherapy (CT), providing virtual environments and multisensorial inputs to train balance in stroke patients. The aim of this study was to assess if immersive VR treatment is more effective than CT to improve balance after stroke. This study got the approval from the Ethics Committee of the University of Almeria. Three chronic ischemic stroke patients were selected. One patient who received 25 sessions of immersive VR intervention for two months was compared with another patient who received equivalent CT and a third patient with no intervention. Balance, gait, risk of falling, and vestibular and visual implications in the equilibrium were assessed. After the interventions, the two patients receiving any of the treatments showed an improvement in balance compared to the untreated patient. In comparison to CT, our results suggest a higher effect of immersive VR in the improvement of balance and a reduction of falls risk due to the active upright work during the VR intervention.
Stroke is considered the first cause of disability  and the third cause of death in westernized countries after cardiovascular diseases and cancer . Stroke is a central nervous system disorder produced by a local interruption of the cerebral blood flow due to the occlusion (ischemic stroke) or rupture (hemorrhagic stroke) of a cerebral blood vessel . As result of brain cortex injury, afferent and efferent neural pathways are affected, and motor, sensitive and cognitive functions become impaired. Motor and cognitive impairments observed in post-stroke patients reduce their functional capacity, their personal autonomy , and social abilities, which results in intensive care and rehabilitation needs with the subsequent economic burden to society and families .
Postural instability or poor balance is a relevant central vestibular symptom in neurologic disorders, such as stroke , in which approximately 83% of stroke survivors show balance impairments . Proprioceptive visual and vestibular inputs to the central nervous system are essential to guarantee the upright position . Thus, errors in the central integration of this postural information can induce gait difficulties with the subsequent increase in risk of falls . In addition, stroke survivors show a number of neurological issues like visual neglect, sensory loss, reduced muscle strength and spasticity, which also increase the risk of fall 1.5–2 times more in post-stroke patients than older adults without brain damage . This results in fractures, tissue injuries, immobility, and psychological fear of falling as additional consequences of falls in stroke patients . Besides, large hospitalization periods due to injury falls are devastating for patient recovery .
The use of virtual reality (VR) has been booming during the last decade, becoming a potential tool in the field of stroke rehabilitation . Virtual reality technology works by displaying a set of digital images that allow the user interacts with a virtual environment or situation that is perceived equivalent to the real physical world . VR has been used in neurorehabilitation in order to encourage a higher number of exercise repetitions and their intensity, and enhances motor learning thanks to the quick feedback possibilities and the multisensorial stimulation . This promotes neuronal plasticity, which would the responsible of VR-induced benefits in stroke rehabilitation . Recent studies have shown that immersive VR protocols in a sitting position and Wii exergames (non-immersive VR) improve motor function, balance, and gait in stroke patients in comparison with conventional therapy (CT) . However, other studies report no statistical differences when comparing immersive or non-immersive VR in a sitting position with CT [18,19]. Moreover, several studies suggest that a neurorehabilitation program combining VR and CT produces a greater improvement than each treatment separately .
Nevertheless, the majority of published works have used non-immersive VR therapies, such as Wii exergames for balance training [21,22]. Recently, improved versions of immersive VR have become available for clinical and research purposes in physical rehabilitation. Thus, immersive VR, thanks to the use of headsets that display 3D digital images that simulate any scenario with high realism, has the capability to make individuals feel as if they’re inside the virtual environment. Moreover, the use of hand-held controllers allows users to interact with virtual elements using their hands as they do real life, allowing exercise repetition, intensity variation, and task-oriented training. Thus, immersive VR postulates as a promising tool for the rehabilitation of motivated stroke patients. The aim of this study is to assess if an experimental protocol based on immersive VR therapy is valid for stroke rehabilitation and produces positive effects in balance and falls risk in comparisons to a CT protocol. For such a reason, two intervention protocols (immersive VR or CT) in comparison with the absence of treatment were tested in three patients diagnosed with ischemic stroke[…]
Background and Objectives: High-intensity interval training (HIIT) is a promising strategy for improving gait and fitness after stroke, but optimal parameters remain unknown. We tested the effects of short vs long interval type and over-ground vs treadmill mode on training intensity.
Methods: Using a repeated measures design, 10 participants with chronic hemiparesis performed 12 HIIT sessions over 4 weeks, alternating between short and long-interval HIIT sessions. Both protocols included 10 minutes of over-ground HIIT, 20 minutes of treadmill HIIT and another 10 minutes over-ground. Short-interval HIIT involved 30 second bursts at maximum safe speed and 30-60 second rest periods. Long-interval HIIT involved 4-minute bursts at ~90% of peak heart rate (HRpeak) and 3-minute recovery periods at ~70% HRpeak.
Results: Compared with long-interval HIIT, short-interval HIIT had significantly faster mean overground speeds (0.75 vs 0.67 m/s) and treadmill speeds (0.90 vs 0.51 m/s), with similar mean treadmill HR (82.9 vs 81.8%HRpeak) and session perceived exertion (16.3 vs 16.3), but lower overground HR (78.4 vs 81.1%HRpeak) and session step counts (1481 vs 1672). For short-interval HIIT, training speeds and HR were significantly higher on the treadmill vs. overground. For long-interval HIIT, the treadmill elicited HR similar to overground training at significantly slower speeds.
Conclusions: Both short and long-interval HIIT elicit high intensities but emphasize different dosing parameters. From these preliminary findings and previous studies, we hypothesize that overground and treadmill short-interval HIIT could be optimal for improving gait speed and overground long-interval HIIT could be optimal for improving gait endurance.
To compare the efficacy of high- and low-frequency noninvasive translingual neurostimulation (TLNS) plus targeted physical therapy (PT) for treating chronic balance and gait deficits due to mild-to-moderate traumatic brain injury (mmTBI).
Participants were randomized 1:1 in a 26-week double-blind phase 1/2 study (NCT02158494) with 3 consecutive treatment stages: in-clinic, at-home, and no treatment. Arms were high-frequency pulse (HFP) and low-frequency pulse (LFP) TLNS.
TLNS plus PT training was initiated in-clinic and then continued at home.
Participants (N=44; 18-65y) from across the United States were randomized into the HFP and LFP (each plus PT) arms. Forty-three participants (28 women, 15 men) completed at least 1 stage of the study. Enrollment requirements included an mmTBI ≥1 year prior to screening, balance disorder due to mmTBI, a plateau in recovery with current PT, and a Sensory Organization Test (SOT) score ≥16 points below normal.
Participants received TLNS (HFP or LFP) plus PT for a total of 14 weeks (2 in-clinic and 12 at home), twice daily, followed by 12 weeks without treatment.
Main Outcome Measures
The primary endpoint was change in SOT composite score from baseline to week 14. Secondary variables (eg, Dynamic Gait Index [DGI], 6-minute walk test [6MWT]) were also collected.
Both arms had a significant (P<.0001) improvement in SOT scores from baseline at weeks 2, 5, 14 (primary endpoint), and 26. DGI scores had significant improvement (P<.001-.01) from baseline at the same test points; 6MWT evaluations after 2 weeks were significant. The SOT, DGI, and 6MWT scores did not significantly differ between arms at any test point. There were no treatment-related serious adverse events.
Both the HFP+PT and LFP+PT groups had significantly improved balance scores, and outcomes were sustained for 12 weeks after discontinuing TLNS treatment. Results between arms did not significantly differ from each other. Whether the 2 dosages are equally effective or whether improvements are because of provision of PT cannot be conclusively established at this time.
Traumatic brain injury (TBI) is a leading cause of injury-induced death and physical disability. Millions of people experience TBI every year,1,2 and an estimated 5.3 million people are living with TBI-related disabilities,3 with up to 57% of patients with TBI experiencing balance disorders.4 Mild-to-moderate traumatic brain injury (mmTBI) encompasses most of TBI cases (83%).5
For many people, the signs and symptoms of mmTBI resolve with time, allowing return to normal daily activities; however, 25%-50% of patients experience chronic symptoms.6, 7, 8, 9, 10 Instability or imbalance can persist after mild TBI,11 which has a significant negative effect on functional status, capacity to return to work, and quality of life7,12, 13, 14, 15, 16 and can increase the risk of falling and repeat injury.17 Rehabilitation techniques consist of basic gait and balance training, but may also include specialized therapies, such as vestibular rehabilitation therapy, vision therapy, motor control retraining, graded exercise, and others.18, 19, 20, 21, 22, 23, 24 Whereas some patients improve with these treatments, others do not.18,25,26
Neurostimulation combined with physical therapy (PT) can potentially affect rehabilitation outcomes,27, 28, 29 and noninvasive brain stimulation can affect neural excitability and may facilitate motor skill learning.30 Cranial nerves V and VII in the tongue and associated neural projections in the brain can be stimulated through noninvasive translingual neurostimulation (TLNS).31 Clinical studies by our group and others indicate that TLNS with targeted PT, combined, can significantly improve outcomes in those with degenerative neurologic disease, spinal cord injury, or stroke.32, 33, 34, 35 In a separate study, we treated 20 persons with multiple sclerosis and an identified gait disturbance with TLNS plus targeted PT.32 Over 14 weeks of treatment, Dynamic Gait Index (DGI) significantly improved from baseline.32 One group reported results from 2 people with chronic incomplete spinal cord injury who completed 12 weeks of TLNS plus balance or gait PT that indicated improvements in both walking speed and skilled walking function.34 Results from a separate randomized controlled trial demonstrated significant improvement in the Mini-Balance Evaluation Test after 2 weeks of TLNS plus targeted PT in 5 subacute stroke survivors.33 These results, as well as similarities in neural dysfunction mechanisms of stroke and TBI,35 support the possibility that TLNS plus targeted PT may be effective for treating chronic balance and gait deficits due to mmTBI.
This 26-week, randomized trial (Clinicaltrials.gov, NCT02158494) was developed to investigate high-frequency pulse (HFP) TLNS plus PT, as treatment for individuals with persistent balance deficit due to mmTBI, compared with low-frequency pulse (LFP) TLNS plus PT as a control. Since trial registration, notable difficulties in establishing controls in neurostimulation studies have become more prominent in the field, particularly focusing on how a low, minimally perceived stimulus serving as a sham can trigger neural activity and produce a response.36, 37, 38, 39, 40 This determination of optimal stimulation parameters has proven challenging across the neurostimulation field, including studies with transcutaneous electrical nerve stimulation,36,37,41, 42, 43 noninvasive trigeminal nerve stimulation,38,39,44 and TLNS.32 Because of these difficulties, the focus of this study shifted from using the LFP as a control to one of a comparison between the treatment arms (PT plus either HFP or LFP); balance assessment after 14 weeks of treatment was the primary outcome measure.
Background: As a result of stroke, patients have problems with locomotion and transfers, which lead to frequent falls. Recovery after stroke is a major goal of rehabilitation, but it is difficult to choose which treatment method is most beneficial for stroke survivors. Recently, powered robotic exoskeletons are used in treatment to maximize the neural recovery of patients after stroke, but there are no studies evaluating the changes in balance among patients rehabilitated with an exoskeleton.
Purpose: The aim of this study was to evaluate the effects of Ekso GT exoskeleton-assisted gait training on balance, load distribution, and functional status of patients after ischemic stroke.
Methods: The outcomes are based on 44 patients aged 55–85 years after ischemic stroke who were previously randomly assigned into two groups: experimental (with Ekso GT rehabilitation) and control (with classical rehabilitation). At baseline and after 4 weeks of treatment, the patients were evaluated on balance, load distribution, and functional status using, respectively a stabilometric platform, the Barthel Index, and the Rivermead Mobility Index.
Results: In the experimental group, balance improved regarding the variables describing sway area as ellipse major and minor axes. In the control group, improvement was noted in sway velocity. After the therapy, total load distribution on feet in both groups showed a small and insignificant tendency toward reduction in the amount of uninvolved limb loading. In the control group, significant load transfer from the backfoot to the forefoot was noted. Both forms of rehabilitation caused significant changes in functional status.
Conclusions: Both training with the use of the Ekso GT exoskeleton and classical physiotherapy lead to functional improvement of patients after ischemic stroke. However, in the experimental group, improvement was observed in a larger number of categories, which may suggest potentially greater impact of treatment with the exoskeleton on functional status. Also, both forms of rehabilitation caused significant changes in balance, but we have noted some trends indicating that treatment with exoskeleton may be more beneficial for some patients. The load transfer from the backfoot to the forefoot observed in the control group was an unfavorable phenomenon. We suggest that the Ekso GT exoskeleton may be a promising tool in the rehabilitation of patients after stroke.
Stroke is the third leading cause of death worldwide and is the most common cause of disability among adults (1, 2). As a result of stroke, patients have problems with locomotion and transfers, which lead to frequent falls. People with hemiparesis have uneven distribution of body mass between the sides of the body, causing balance and coordination disorders, deep and superficial sensation, increased muscle tone, and fear of falling (2, 3). Patients have problems with lack of normal postural muscle tone, and proper reciprocal innervation as well as normal, automatic movement patterns and balance reactions (4). Some studies have reported that balance alterations significantly limit the physical activity of stroke patients, which may be the reason for deconditioning of patients in the chronic phase and reduction in their gait possibilities as well as other activities of daily living (5). That is why gait rehabilitation and also balance therapy are very important in improving the quality of everyday and social life of those patients (6).
Gait training may improve not only strength, endurance, and coordination of the lower limbs but also the entire body of the patient, influencing general fitness and endurance, balance, normalization of muscle tone, and functional improvement (7). The Barthel Index (BI) and Rivermead Mobility Index (RMI) tests are considered to be proper criteria for assessing a patient’s functional state after stroke and good indicators of the effectiveness of the applied therapy (8, 9).
Recovery after stroke is a major goal of rehabilitation, but it is difficult to choose which treatment method is most beneficial for stroke survivors. Recently, powered robotic exoskeletons are used in treatment to maximize the neural recovery of patients after stroke (10, 11). However, in a review paper, Louie and Eng (12) have reported that only four different types of powered exoskeletons have been studied among a small number of stroke patients, and the published data were controversial. Moreover, in the available literature, there are no studies evaluating the changes in balance among patients rehabilitated with an exoskeleton. Most authors have reported various aspects of walking, and only a few papers have presented data concerning changes in balance. Additionally, most of the studies used subjective tools such as the Berg Balance Scale (13, 14). There is a lack of studies in which changes in balance and load distribution due to rehabilitation with the exoskeleton would be examined using an objective tool—stabilometric platform; therefore, this study undertakes this task for the first time.
The aim of this study was to evaluate the effectiveness of rehabilitation with Ekso GT exoskeleton in patients after ischemic stroke and to compare this type of therapy with the classical model of rehabilitation. The novelty of this study was the verification of the robot-assisted gait training effects on balance, load distribution, and functional status of stroke patients.[…]
Background: Robot assisted gait training is a rapidly evolving rehabilitation practice. Various robotic orthoses have been developed during the past two decades for the gait training of patients suffering from neurologic injuries. These robotic orthoses can provide systematic gait training and reduce the work load of physical therapists. Biomechanical gait parameters can also be recorded and analysed more precisely as compared to manual physical therapy.
Objectives: A review of robotic orthoses developed for providing gait training of neurologically impaired patients is provided in this paper. Methods: Recent developments in the mechanism design and actuation methods of these robotic gait training orthoses are presented. Control strategies developed for these robotic gait training orthoses in the recent years are also discussed in detail. These control strategies have the capability to provide customised gait training according to the disability level and stage of rehabilitation of neurologically impaired subjects.
Results: A detailed discussion regarding the mechanism design, actuation and control strategies with potential developments and improvements is provided at the end of the paper.
Conclusions: A number of robotic orthoses and novel control strategies have been developed to provide gait training according to the disability level of patients and have shown encouraging results. There is a need to develop improved robotic mechanisms, actuation methods and control strategies that can provide naturalistic gait patterns, safe human-robot interaction and customized gait training, respectively. Extensive clinical trials need to be carried out to ascertain the efficacy of these robotic rehabilitation orthoses.
A ground-breaking ’bicycle’ which simulates muscle movements is helping a range of patients with long-term mobility problems caused by head or spinal injuries, stroke or MS. Julie Blackburn watched a demonstration.
One morning in April last year Jason Moffatt from Peel woke up with a headache.
And not just any normal headache, as he recalls: ’I don’t usually do headaches and this one was the worst: it felt like my head was about to explode out of the top.’
He put up with it for a while then decided it ’might be worth popping into the A&E’. It was lucky he did because an examination and subsequent scan revealed dried blood on his brain. He had suffered a bleed.
Jason was flown off the island to Walton Hospital in Liverpool for an operation but during surgery he suffered a stroke which left him paralysed down the left side of his body.
’I then spent three months in Liverpool, learning to walk again and do everyday tasks,’ he says.
While there, Jason realised that strokes do not just happen to older people, but to plenty of younger ones too.
Back on the island his rehabilitation programme has included sessions on a Functional Electrical Stimulation (FES) bicycle.
FES is a technique that uses low energy electrical pulses and has been found to be effective in restoring voluntary functions.
These pulses artificially generate body movements in specific muscle groups through electrodes placed on the patient’s body.
Jason’s physiotherapist is Christine Wright, from the Community Adult Therapy Services team. She specialises in helping patients with long-term neurological conditions and she demonstrated how the machine works.
Once the electrodes are positioned on the muscle groups which Jason needs to get working, he sits in a chair which is attached to the machine with his legs strapped onto the ’pedals’.
His session starts with a warm-up of around one and a half minutes before the resistance increases and he is working hard, concentrating on putting in more effort on his left leg.
Having started his treatments with around 10 to 15 minutes on the bike, Jason has now built up to 30 minutes in each session.
’I’ll be sweating at the end of this,’ he says.
As she keeps an eye on his progress, Christine explains: ’Although it’s a bike, the pattern of movement is simulating walking: each turn of the bike gives Jason a step.
’Numbers of repetitions lead to changes in the brain and the development of new neural pathways.
’The bike also strengthens the muscles so that, when those connections in the brain reform, those muscles are there, ready to be used.’
It has probably served Jason well that he was a keen cyclist before he became ill, having done the End2End mountain bike race, as well as the Parish Walk to Peel and the End to End walk.
He knows that he is also fortunate to have the use of the FES bicycle. When he was doing rehab in Liverpool, at a large, dedicated 30-bed rehab centre there, they didn’t have one: ’It was basically just a gym,’ he recalls. This is true of most rehab units where FES simulators are not part of the standard kit.
’We’re incredibly lucky to have this,’ Christine says.
This machine was purchased for the Community Physiotherapy Department two years ago with £11,695 provided by the Henry Bloom Noble Healthcare Trust.
The Trust’s main remit is to provide equipment over and above what the DHSC in the island would be able to buy.
It has been a great success for Christine and the other physiotherapists, Graihagh Betteridge and Rosie Callow, who are also trained to use the machine.
As well as working on patients’ lower limbs, the simulator can be detached from the bicycle element and used as a portable machine.
It can then be taken to people’s homes and used to help them regain shoulder and arm movement.
At the moment the department has to ration the machine’s use.
They take around 25 to 30 patients at a time, usually for a six-eight week course, with a session once a week on the bike.
They have a waiting list, both with new patients and patients who have had a course already and need further treatment. Because of this the Henry Bloom Noble Healthcare Trust has agreed to purchase a second bicycle so more patients will have the chance to use one.
Chairman of the Trust, Terry Groves, said: ’Jason’s story, and many others, have shown the value of this FES bicycle in managing differing conditions and rehabilitation.
’Recognising the continuing donations made to our Healthcare Trust we are delighted to fund the acquisition of this second FES bicycle from our funds so that continuing strides in this important area of aftercare can be made.’
Jason himself is delighted with the progress he has made using the bicycle: ’I can see an improvement. I can walk further and with a better balance,’ he says.
His aim now is to get back on his (real) bike.
Christine smiles when he says this. ’You will do it,’ she assures him.