[Abstract] Vagus Nerve Stimulation Paired With Rehabilitation for Post-Stroke Arm Impairment: One Year Follow-Up of the VNS-REHAB Pivotal Trial

Abstract

Background: Persistent post-stroke impairment of the arm and hand is debilitating after stroke. Pairing vagus nerve stimulation (VNS) with upper extremity (UE) rehabilitation improves such deficits after 5 months and was approved by the FDA in 2021. Here, we present 1-year outcomes from the VNS-REHAB pivotal trial.

Methods: Stroke participants with moderate-to-severe UE impairment were randomized to task-specific rehabilitation plus either active VNS (n=53, VNS) or sham VNS (n=55, Control). After baseline assessment (Pre-therapy), both groups did 6 wk. of in-clinic therapy followed by a 3-mo. home exercise program combined with active or sham VNS (post90). Controls then crossed over to receive 6 wk. of active VNS followed by a 3-mo. home exercise program (Cross-over post90). Both groups continued active VNS with a home exercise program through 1 year, after which change from Pre-therapy baseline in Fugl-Meyer Assessment-Upper Extremity (FMA-UE) and Wolf Motor Function Test (WMFT) scores were obtained. To determine whether participants made additional gains, 1 year outcome scores (n=70) were also compared to post90 (n=38, VNS) and Cross-over post90 (n=32, Control) scores. Data was available from 74 participants at one year, with others not available mainly due to COVID-19.

Results: At 1-year, both FMA-UE and WMFT scores improved from Pre-therapy baseline by 5.3±6.9 (CI=3.7-6.9, p<0.001) and 0.51±0.52 (CI=0.39-0.63, p<0.001) points, respectively. FMA-UE change at 1-year was not significantly different from the post90 (VNS) and Cross-over post90 (control) timepoints (n=70, mean difference: -0.3±4.1, CI=-1.3-0.67, p=0.52), but WMFT was, by an additional 0.09 points (n=70, mean difference: 0.09±0.35, CI=0.01-0.18, p=0.03), indicating that participants either improved or maintained motor gains through 1 year.

Conclusion: Improvements in arm and hand function with VNS were maintained at 1-year follow-up, supporting use of VNS paired with rehabilitation as a long-term treatment option for individuals with post-stroke UE impairment. Limitations include sample size and lack of details of therapeutic regimens over the long term. Future studies and an ongoing clinical registry will explore the long-term impact of active VNS in real-world settings.

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[Slideshow] Stroke: What You Need to Know

Medically Reviewed by Carol DerSarkissian, MD on January 18, 2022

What Is a Stroke?

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A stroke is a medical emergency. It happens when a blood vessel in the brain bursts or, more commonly, when a blockage happens. Without treatment, cells in the brain quickly begin to die. This can cause serious disability or death. If a loved one is having stroke symptoms, call 911 right away.

Stroke Symptoms

2/13

Call 911 right away about signs of a stroke, which may include sudden:

• Numbness or weakness of the body, especially on one side
• Vision changes in one or both eyes, or trouble swallowing
• Severe headache with an unknown cause
• Problems with dizziness, walking, or balance
• Confusion, trouble speaking or understanding others

Think FAST

3/13

The FAST test helps spot symptoms. It stands for:

Face drooping. Ask for a smile. Does one side droop?

Arm weakness or numbness.

Speech. Can the person repeat a simple sentence? Do they have trouble or slur words?

Time to call 911. Don’t delay.

Time = Brain Damage

4/13

Every second counts. Without oxygen, brain cells begin dying within minutes. Once brain tissue has died, the body parts controlled by that area won’t work right. This makes stroke a top cause of long-term disability. There are clot-busting drugs that can curb brain damage, and they must be given in a short time — usually within 3 hours of when symptoms start.

Diagnosis

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Tests may start when you’re still in the ambulance. Once you get to the ER, you’ll get imaging tests such as a CT scan, MRI, or ultrasound. You may get other types of tests, such as an EKG (checks your heart’s electrical activity) and an EEG (checks your brain’s electrical activity).

Ischemic Stroke

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This is the most common type of stroke: Nearly nine out of 10 fall into this category. An ischemic stroke happens when a blood clot blocks the supply of blood to or in the brain. The clot may start in that spot or travel through the blood from elsewhere in the body. Clogged arteries are a top cause.

Hemorrhagic Stroke

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Hemorrhagic strokes happen when a weakened blood vessel in the brain bursts. The result is bleeding inside the brain that can be hard to stop. The most common cause is high blood pressure. Other causes include aneurysms and AVMs (arteriovenous malformations), which weaken blood vessels in the brain.

‘Mini-Stroke’ (TIA)

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Transient ischemic attacks, often called “mini-strokes,” are also an emergency. When they happen, blood flow is temporarily hampered in part of the brain, causing stroke-like symptoms. When the blood flows again, the symptoms stop. You can’t tell at the time if it’s a stroke or TIA. So call 911. Having a TIA is also a warning sign, so see your doctor if you think you’ve had one.

Emergency Treatment

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Ischemic strokes: The goal is to restore blood flow. A clot-busting medication called tPA is very good at dissolving clots and cutting the chance of long-term damage, but it must be given in time — usually within 3 hours. Hemorrhagic strokes: These are harder to manage. Treatment usually involves trying to control high blood pressure, bleeding, and brain swelling.

Causes

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Ischemic strokes: Clogged arteries are a top cause. Plaque made of fat, cholesterol, and other things builds up in the arteries, leaving less space for blood to flow. A blood clot may lodge in this narrowed space and cause an ischemic stroke. All that plaque makes it easier for a clot to form and can also rupture, blocking blood flow.

Hemorrhagic strokes: These can happen if uncontrolled high blood pressure bursts a weakened artery.

Risk Factors

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Your chance of having a stroke rises with age and if you have:

• Had a stroke or TIA before
• Heart disease
• High blood pressure
• High cholesterol
• Diabetes
• Obesity
• Sickle cell disease

Smoking, heavy drinking, and not being active also raise your risk.

What’s On Your Plate?

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Eating too much fat and cholesterol can cause plaque to narrow arteries. Too much salt may lead to high blood pressure. Eating plenty of fruits, vegetables, whole grains, and fish may help lower your stroke risk.

Lowering Your Risk

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Find out if you have any conditions that you need to treat to help prevent a stroke. That may mean taking medicine and also boosting healthy habits, from the foods you eat to being active and not smoking. It’s never too late to start.

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[ARTICLE] Magnetic Resonance Imaging in Acute Ischemic Stroke – Full Text

Abstract

Ischemic stroke is one of the leading causes of mortality and disability. The only effective non-surgical treatment for acute ischemic stroke within three to four and a half hours of the onset of symptoms is thrombolytic therapy. Time is of the essence when diagnosing and treating an acute ischemic stroke. After evaluating the advantages and disadvantages of thrombolysis, selecting the ideal patient for the indication is essential. Magnetic Resonance Imaging (MRI) is more sensitive and specific than Computed Tomography (CT) scans when identifying acute ischemic stroke. In approximately 80% of cases, infarcts are detectable within the first 24 hours. MRI can detect an ischemic stroke within a few hours of its onset. Multimodal imaging provides information for the diagnosis of ischemic stroke, patient selection for thrombolytic therapy, and prognosis estimation.

Introduction & Background

Ischemic stroke is one of the leading causes of death and disability. In recent years, several attempts have been made to improve the efficacy of acute ischemic stroke therapies. Thrombolytic therapy is the only effective treatment for acute ischemic stroke within three to four and a half hours after the beginning of symptoms. Ongoing research focuses on thrombolysis indications and therapeutic window treatment. After assessing the risks and benefits of thrombolysis, selecting a suitable patient for the indication is essential [1,2]. A CT scan without contrast is a fast and reliable method for detecting cerebral bleeding, but it is not sensitive enough to detect ischemic changes in the early hours. Its sensitivity ranges between 40 and 60 percent in the first six hours following activation. The CT scan imaging is acquired prior to diffusion-weighted imaging (DWI), one of the high-resolution MRI sequences in regions with decreased blood flow [3].

“Time is brain” is essential for diagnosing and treating acute ischemic stroke. Every minute, the occlusion of the middle cerebral artery loses 9 million neurons. Brain imaging is the primary tool for diagnosing an ischemic stroke. Brain imaging helps differentiate between subacute and chronic lesions of the brain. This is essential for the selection of patients for thrombolysis or thrombectomy. In recent years, acute ischemic stroke assessment has dominated imaging investigations [4].

MRI is more sensitive and specific than a CT scan for diagnosing acute ischemic stroke. Study results show immediate non-contrast MRI is about five times more sensitive than and twice as accurate as immediate non-contrast CT for diagnosing ischemic stroke. Non-contrast CT and MRI were equally effective in the diagnosis of acute intracranial hemorrhage. Non-contrast CT has been the standard in emergency stroke treatment, primarily to exclude hemorrhagic stroke, which cannot be treated with clot-busting therapies. In approximately 80% of cases, infarcts are detectable within the first 24 hours. MRI can detect ischemic stroke within the first few hours after onset. Multimodal MRI is useful for ischemic stroke diagnosis and acute phase therapy planning. Different imaging results from the MRI sequence such as Diffusion-Perfusion mismatch determine the mechanism of the stroke, which influences the prognosis and is essential for determining the optimal treatment. The lesion mismatch profile on MRI aids in evaluating the potential risks and benefits of thrombolysis by providing information on the age of the ischemic lesion or information regarding salvageable tissue [3,5].[…]

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[Abstract] Occupational Therapists’ Perceptions of Robotics Use for Patients With Chronic Stroke

Importance: The effectiveness of robotic therapy in stroke rehabilitation has been established by many studies, and occupational therapists should consider using robotics in their clinical practice. However, little is known about occupational therapy practitioners’ experience using robotics.

Objective: To explore occupational therapists’ perceptions of the mechanisms and outcomes of occupational therapy using robotics with chronic stroke patients.

Design: Qualitative study with semistructured focus group interviews. Data were analyzed using thematic analysis.

Setting: Hospitals and institutions in Japan in which occupational therapists used robotics in their clinical practice.

Participants: Twenty-seven occupational therapists with experience in using robotics with chronic stroke patients as a self-training method that involved repetitive movements of a paralyzed upper extremity. Participants were interviewed in nine focus groups.

Results: Five themes—(1) body function, (2) values, (3) performance skills, (4) occupational performance, and (5) participation—and 12 subthemes were identified on the basis of the Occupational Therapy Practice Framework: Domain and Process (3rd ed.). Participants indicated that robotics improved patients’ body function and promoted a desire for independence, which resulted in improved occupational performance and participation in their desired occupations.

Conclusions and Relevance: Occupational therapists regarded robotics as an adjunct to other therapy, which improved patients’ body function and promoted their desire for independence.

What This Article Adds: Findings from this research provide insights into using robotics to enhance occupational therapy practice.

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[ARTICLE] Post COVID-19 Vaccination-Associated Neurological Complications – Full Text

Abstract

Purpose

Neurological sequelae after COVID-19 vaccination are rare. We investigated the possible pathogenesis behind the development of neurological complications within a short period after Saudi residents received a COVID-19 vaccine.

Patients and Methods

We evaluated 18 patients who recently received a COVID-19 vaccine (Comirnaty and Vaxzevria vaccines) and presented with neurological complications to the Saudi German Hospitals in Jeddah, Saudi Arabia. Neurologists assessed the patients’ clinical presentation, radiological investigations, and laboratory findings.

Results

Three patients who received the first dose of the Vaxzevria vaccine experienced severe cerebral venous thrombosis, two of them were complicated by intracranial hemorrhage. Their laboratory investigations showed very high d-dimers and severe thrombocytopenia, which have been linked to higher mortality and poor outcome. Ischemic stroke occurred in eight cases (44.4%) with a predominance in older male patients. Three patients presented with seizures, two had optic neuritis. Guillain–Barré syndrome (GBS) and Miller Fisher syndrome (MFS) occurred in two male patients following vaccination with Comirnaty.

Conclusion

Neurological complications after COVID-19 vaccinations are very rare, and only a few cases have been reported worldwide. The shared pathophysiological basis between COVID-19 viral infection and COVID-19 vaccines stands behind the very rare neurological complications resulting from the hypercoagulable state triggered by the general inflammatory condition. We suspect some differences in the pathogenesis of ischemic stroke caused by COVID-19 infection and COVID-19 vaccines, which render COVID-19 vaccine-associated ischemic stroke more responsive to treatment. To date, no definitive association between the vaccine and GBS has been proven by any strong evidence, but it has recently been added as a very rare side effect of the Janssen COVID-19 vaccine. No possible links of Miller Fisher syndrome to COVID-19 vaccines have been reported before the one reported in this study.[…]

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Figure 2
Radiological brain imaging of case, 1, 2 and 3 presenting with Cerebral venous thrombosis. (A) CT Brain case 1, showing right cortical hemorrhage (arrow); (B) CT Brain case 2, showing intracerebral (headarrow) and intraventricular (arrow) hemorrhage; (C) MRI GRE case 3 showing right temporal blooming suggestive of hemorrhage within venous infarction (arrow); (D) MRI GRE case 1, showing blooming within cortical veins suggesting thrombosis (headarrows); (E) MR venography case 2, showing non visualized most of cerebral venous sinus (arrows) indicating extensive thrombosis; (F) CT venography case 3, showing filling defect within right sigmoid sinus (arrow).

[Abstract] Multimodal Mental Practice Versus Repetitive Task Practice Only to Treat Chronic Stroke: A Randomized Controlled Pilot Study

Importance: Occupational therapists are the primary clinicians tasked with management of the more affected upper extremity (UE) after stroke. However, there is a paucity of efficacious, easy-to-use, inexpensive interventions to increase poststroke UE function.

Objective: To compare the effect of a multimodal mental practice (MMMP) regimen with a repetitive task practice (RTP)–only regimen on paretic UE functional limitation.

Design: Secondary analysis of randomized controlled pilot study data.

Setting: Outpatient clinical rehabilitation laboratory.

Participants: Eighteen chronic stroke survivors exhibiting moderate, stable UE impairment.

Intervention: Participants administered RTP only participated in 45-min, one-on-one occupational therapy sessions 3 times per week for 10 wk; participants administered MMMP completed time-matched UE training sessions consisting of action observation, RTP, and mental practice, delivered in 15-min increments.

Outcomes and Measures: The Action Research Arm Test, the UE section of the Fugl-Meyer Scale, and the Hand subscale of the Stroke Impact Scale (Version 3.0) were administered 1 wk before and 1 wk after intervention.

Results: The MMMP group exhibited significantly larger (p < .01) increases on all three outcome measures compared with the RTP group and surpassed minimal clinically important difference standards for all three UE outcome measures.

Conclusions and Relevance: Because of the time-matched duration of MMMP and RTP, findings suggest that MMMP may be just as feasible as RTP to implement in clinical settings. Efforts to replicate results of this study in a large-scale trial are warranted.

What This Article Adds: This study shows the efficacy of an easy-to-use protocol that significantly increased affected arm function even years after stroke.

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[Abstract] Structural Magnetic Resonance Imaging Correlated with Motor Function of Upper Extremity in Patients with Chronic Stroke

Abstract

Background

Ischemic cerebrovascular stroke is defined as an acute neurological dysfunction caused by focal cerebral infarction after decrease in the blood supply of the brain either by stenosis or occlusion leading to gross physical impairment or disability lasting more than 24 hours.

Objective

To assess correlation between site of infarction and upper extremity ( UE) function in chronic stroke patients.

Methodology

A cross sectional study with (30) Patients with chronic ischemic stroke ( >3 months) suffering from persistent UE motor function impairment, MRI brain done to assess the site of infarction. UE motor function assessment using the Fugl Meyer Assessment (FMA-UE) Scale.

Results

The current study found that no significant correlation between the site of infarction and UE motor function.

Conclusion

We concluded that the site of infarction not correlated with UE motor function in chronic stroke patients.

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[WEB] NEW STROKE REHABILITATION SYSTEM PROVEN TO WORK IN IMPAIRED STROKE PATIENTS

By Iednewsdesk

A stroke rehabilitation system, developed by MicroTransponder Inc and studied by a team at the University of Glasgow, has been shown to significantly improve arm impairment and function in people with long-term arm weakness after ischaemic stroke.

Long-term loss of arm function after ischaemic stroke is common, and the results of the study – published today in The Lancet – showed two to three times greater improvement with Vagus Nerve Stimulation (VNS) when it was combined with intense physical therapy, compared to intense physical therapy alone.

Strokesign

Approximately 80% of people with acute stroke have arm weakness, and as many as 50%-60% still have persistent problems six months later. There are currently few effective treatments to enhance arm recovery after stroke, and intense physical therapy is currently the best treatment option.

In the study – which looked at 108 people in the United States and the United Kingdom with moderate to severe arm problems – trial participants were randomised to intense physical therapy paired with active VNS or intense physical therapy paired with sham VNS (Control group).

VNS involves implant surgery, a bit like a cardiac pacemaker. Once implanted, the device stimulates the vagus nerve on the left side of the neck during intensive task-specific rehabilitation. The vagus nerve connects with areas of the brain that cause release of important neuromodulators or chemicals which, when combined with physical therapy, helps the brain ’re-learn’ movements.

After 6 weeks of out-patient therapy and a further ninety days of home based therapy, 47% of the people in the VNS group showed a clinically meaningful response versus 24% in the control group. People who received VNS also showed improvement over the control group in quality of life and activity measures.

Jesse Dawson, Professor of Stroke Medicine, at the University of Glasgow and principal investigator of the trial, said: “This is the first study to find clinically- and statistically-significant effects of a neuromodulation therapy for people with arm and hand weakness after chronic stroke.

“We saw improvement for the VNS group in both impairment and functional measures compared to Controls. In particular, the clinically meaningful response rate doubled with VNS for both impairment and functional outcomes. Importantly, the VNS doesn’t work alone – it adds to the effect of intensive rehabilitation”

Dr. Teresa Kimberley, PhD, PT, Professor and Director of the Brain Recovery Lab at MGH Institute of Health Professions, a senior investigator on the project through both the pilot and pivotal studies, added: “The results of this clinical study suggest that the addition of VNS enhances the effect of best practice stroke rehabilitation

“We are looking forward to potentially establishing the therapy as part a new standard of care for stroke rehabilitation. “

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[ARTICLE] Novel TMS for Stroke and Depression (NoTSAD): Accelerated Repetitive Transcranial Magnetic Stimulation as a Safe and Effective Treatment for Post-stroke Depression – Full Text

Background: Post-stroke depression (PSD) affects up to 50% of stroke survivors, reducing quality of life, and increasing adverse outcomes. Conventional therapies to treat PSD may not be effective for some patients. Repetitive transcranial magnetic stimulation (rTMS) is well-established as an effective treatment for Major Depressive Disorder (MDD) and some small trials have shown that rTMS may be effective for chronic PSD; however, no trials have evaluated an accelerated rTMS protocol in a subacute stroke population. We hypothesized that an accelerated rTMS protocol will be a safe and viable option to treat PSD symptoms.

Methods: Patients (N = 6) with radiographic evidence of ischemic stroke within the last 2 weeks to 6 months with Hamilton Depression Rating Scale (HAMD-17) scores >7 were recruited for an open label study using an accelerated rTMS protocol as follows: High-frequency (20-Hz) rTMS at 110% resting motor threshold (RMT) was applied to the left dorsolateral prefrontal cortex (DLPFC) during five sessions per day over four consecutive days for a total of 20 sessions. Safety assessment and adverse events were documented based on the patients’ responses following each day of stimulation. Before and after the 4-days neurostimulation protocol, outcome measures were obtained for the HAMD, modified Rankin Scale (mRS), functional independence measures (FIM), and National Institutes of Health Stroke Scales (NIHSS). These same measures were obtained at 3-months follow up.

Results: HAMD significantly decreased (Wilcoxon p = 0.03) from M = 15.5 (2.81)−4.17 (0.98) following rTMS, a difference which persisted at the 3-months follow-up (p = 0.03). No statistically significant difference in FIM, mRS, or NIHSS were observed. No significant adverse events related to the treatment were observed and patients tolerated the stimulation protocol well overall.

Conclusions: This pilot study indicates that an accelerated rTMS protocol is a safe and viable option, and may be an effective alternative or adjunctive therapy for patients suffering from PSD. Future randomized, controlled studies are needed to confirm these preliminary findings.

Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT04093843.

Introduction

The interplay between depression and cerebrovascular disease is complex and clinically important. Post-stroke depression (PSD) is the most common neuropsychological complication of stroke, with a prevalence of ~33% (1) in stroke survivors. PSD adversely influences outcomes by reducing quality of life, increasing caregiver burden, and increasing early mortality as much as ten-fold (2–4). As acute stroke interventions continue to improve, stroke survivorship and associated morbidity will also increase, making the need to explore innovative treatments for PSD even more urgent.

Despite the significant clinical burden of PSD, there are limited treatment options to prevent or reduce its severity. Psychotherapy and pharmacotherapy are well-established as treatments of choice in major depression, however a subset of patients do not respond to either of these first-line therapies (5). Selective Serotonin Reuptake Inhibitor (SSRI) use has been associated with increased risk of hemorrhagic complications as well as increased risk of falls in the elderly, while other studies have shown that SSRIs are actually associated with increased risk for stroke, myocardial infarction, and all-cause mortality (6). A recent meta-analysis for stroke patients concluded that antidepressants did not significantly improve patients’ general recovery, achieved varied response rates, and were not tolerated due to adverse effects (7). Compliance, communication problems, and lack of access to psychiatric care are further challenges to treating PSD.

Repetitive transcranial magnetic stimulation (rTMS) may represent an effective treatment option that mitigates the issues associated with the standard PSD interventions. The FDA approved rTMS for patients with Major Depressive Disorder (MDD) in 2008 (8). The typical rTMS protocol that has been used effectively for major depression is 5 days per week for 4–6 weeks. Conventional rTMS paradigms have been studied in the PSD population, and many studies including a meta-analysis have shown that conventional rTMS is likely effective for chronic, refractory PSD (9, 10). However, these conventional paradigms may be inconvenient for patients with limited transportation access and may limit compliancy of patients. Therefore, an accelerated protocol which minimizes the number of days needed to complete the full treatment may be more accessible to patients and may increase compliancy. While there have been some accelerated rTMS paradigms that have been designed to treat conditions such as alcohol withdrawal and treatment-resistant depression (11–14), similar accelerated protocols have not been studied in patients suffering from PSD. Applying accelerated rTMS to the PSD population comes with unique and complex factors. For example, the theoretical risk of seizure using an accelerated protocol may be higher, and this risk may increase even further in patients in the acute to subacute stroke period. Therefore, it is important to study the safety of an accelerated protocol in this population. In addition, the period immediately following cerebrovascular ischemia potentially represents a biologically unique phase amenable to intervention given that both neuroplasticity as well as recurrent stroke risk are highest during this time (15, 16).

There is a clear medical need to further address the impact of rTMS for PSD and to optimize stimulation parameters. We hypothesized that an accelerated 4-days rTMS protocol would be a safe and viable method for treating PSD and would help ameliorate depressive symptoms.[…]

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[ARTICLE] Effects of Exoskeleton Gait Training on Balance, Load Distribution, and Functional Status in Stroke: A Randomized Controlled Trial – Full Text

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.

Introduction

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.[…]

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