Posts Tagged Lower Limp

[ARTICLE] Effects of Lower Extremities Constraint Induced Movement Therapy on Gait and Balance of Chronic Hemiparetic Patients After Stroke: Description of a Study Protocol for a Randomized Controlled Clinical Trial. – Full Text

Abstract

Background

Protocols involving intensive practice have shown positive outcomes. Constraint Induced Movement Therapy (CIT) appears to be one of the best options for better outcomes in upper limb rehabilitation, but we still have little data about Lower Extremities – Constraint Induced Movement Therapy (LE-CIT) and its effects on gait and balance.

Objective

To evaluate the effects of an LE-CIT protocol on gait functionality and balance in chronic hemiparetic patients following a stroke.

Methods

The study adopts a randomized, controlled, single-blinded study design. 42 patients who suffered a stroke event, in the chronic phase of recovery (>6 months), with gait disability (no community gait), able to walk at least 10 meters with or without the advice or support of 1 person, will be randomly allocated to 2 groups: the LE-CIT Group or the Control Group (Intensive Conventional Therapy). People will be excluded if they have speech deficits that render them unable to understand and/or answer properly to evaluation scales and exercises selected for the protocol and/or if they have suffered any clinical event between the screening and the beginning of the protocol. Outcome will be assessed at baseline (T0), immediately after the intervention (T1), and after 6 months (T2). The outcome measures chosen for this trial are: 6 minute walk test (6minWT), 10 meter walk test (10mWT), Timed Up and Go (TUG), 3-D gait analysis (3DGA), Mini Balance Evaluation Systems Test (Mini-BESTest) and, as a secondary measure, Lower Extremity Motor Activity Log will be evaluated (LE-MAL). The participants in both groups will receive 15 followed days of daily exercise. The participants in the LE-CIT Group will be submitted to this protocol 2.5 hour/day for 15 followed days. It will include: 1) intensive supervised training, 2) use of shaping as strategy for motor training, and 3) application of a transfer package (plus 30 minutes). The Control Group will receive conventional physiotherapy for 2.5 hours/day over 15 followed days (the same period as the CIT intervention). Repeated measures analyses will be made to compare differences and define clinically relevant changes between groups.

Results

Data collection is currently on-going and results are expected in 2021.

Discussion: LE-CIT seems to be a good protocol for inclusion into stroke survivors’ rehabilitation as it has all the components needed for positive results, as well as intensity and transference of gains to daily life activities.

Trial Registration: www.ensaiosclinicos.gov.br (Register Number: RBR-467cv6). Date of registration: October 10, 2017. “Effects of Lower Extremities – Constraint Induced Therapy on gait and balance function in chronic hemipretic post-stroke patients”.

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[Abstract] Muscle and tendon properties of the spastic lower leg after stroke defined by ultrasonography: a systematic review

Abstract 


Introduction: Peripheral muscle and tendon changes after stroke can influence the functional outcome of patients. The aim of this systematic review was to summarize the evidence of ultrasonographic changes in morphological muscle and tendon properties of the spastic hemiparetic lower leg in patients with first ever stroke.

Evidence acquisition: A systematic search was conducted through PubMed, Embase, Scopus, Cinahl, Cochrane Library, and manual searches from inception until 1st of May 2020. Observational case control or cohort studies were included. Risk of bias was evaluated by using the Newcastle-Ottawa Quality Assessment Scale. Outcome parameters of interest included muscle thickness, muscle and tendon length, fascicle length, pennation angle and echo-intensity.

Evidence synthesis: Nine studies investigated outcome parameters beyond one-month after stroke. We are unable to make a comprehensive statement. Nevertheless, there are some arguments for reduced muscle thickness and reduced fascicle length of the hemiplegic, spastic leg.

Conclusions: Despite the fact that objective assessment by ultrasonography holds promise for diagnosis and follow-up of spastic hemiparesis after stroke, more evidence is needed to determine how changes in morphological muscle and tendon properties are related to muscle weakness, severity of spasticity and compensation strategies such as disuse or overuse in longitudinal studies starting early after stroke.

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[Abstract] Combined methods of rehabilitation of patients after stroke: virtual reality and traditional approach – Full Text PDF

OBJECTIVES: The aim of the research was to verify the possibilities of using virtual reality in combination with classical approaches to the rehabilitation of patients after stroke. 

MATERIAL AND METHODS: As part of rehabilitation, we examined the possibilities of rehabilitation of the upper, lower limbs and fine mobility of the upper limbs in a selected group of patients that met the criteria for inclusion in a combined rehabilitation program using virtual reality with a focus on testing different approaches, devices and applications. At the same time, we tried to identify quantitative and qualitative parameters that could be objectively measured and based on them to evaluate the progress of patients in rehabilitation or in personalizing individual rehabilitation scenarios. 

RESULTS: In patients who underwent a combined method of rehabilitation, we observed progress in the development of their ability to improve motor skills. We identified various categories of parameters that can be evaluated by artificial intelligence methods, and we also identified that the key elements in the use of virtual reality as a rehabilitation method are the so-called “WOW” effect and the creation of an emotional change in the patient that motivates him to rehabilitate. 

CONCLUSION: We have shown that virtual reality methods have the potential to accelerate rehabilitation and increase the motivation of selected groups of patients after stroke.


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[ARTICLE] Portable neuromodulation induces neuroplasticity to re-activate motor function recovery from brain injury: a high-density MEG case study – Full Text

Abstract

Background

In a recent high-profile case study, we used functional magnetic resonance imaging (fMRI) to monitor improvements in motor function related to neuroplasticity following rehabilitation for severe traumatic brain injury (TBI). The findings demonstrated that motor function improvements can occur years beyond current established limits. The current study extends the functional imaging investigation to characterize neuromodulation effects on neuroplasticity to further push the limits.

Methods

Canadian Soldier Captain (retired) Trevor Greene (TG) survived a severe open-TBI when attacked with an axe during a 2006 combat tour in Afghanistan. TG has since continued intensive daily rehabilitation to recover motor function, experiencing an extended plateau using conventional physical therapy. To overcome this plateau, we paired translingual neurostimulation (TLNS) with the continuing rehabilitation program.

Results

Combining TLNS with rehabilitation resulted in demonstrable clinical improvements along with corresponding changes in movement evoked electro-encephalography (EEG) activity. High-density magneto-encephalography (MEG) characterized cortical activation changes in corresponding beta frequency range (27 Hz). MEG activation changes corresponded with reduced interhemispheric inhibition in the post-central gyri regions together with increased right superior/middle frontal activation suggesting large scale network level changes.

Conclusions

The findings provide valuable insight into the potential importance of non-invasive neuromodulation to enhance neuroplasticity mechanisms for recovery beyond the perceived limits of rehabilitation.

Background

Acquired brain injuries, such as traumatic brain injury (TBI) and stroke, commonly result in significant long-term disability [12], affecting critical abilities such as movement control. With increasing TBI survival rates from conflict zones, there is a growing push for novel therapies, which break down prior conventional limits of recovery [3]. Innovations in rehabilitation are beginning to integrate technology advances, particularly with the underlying concept of promoting enhanced recovery through neuroplasticity [45]. In terms of clinical implementation, one approach to translation is to demonstrate individual-level technology advances first and then scale to larger clinical applications. This approach enables a research-driven framework in which practitioners can better address issues and challenges related to “false hope” by evaluating new treatments through research [67]. This is particularly germane to the increasing broader societal awareness of neuroplasticity and the potential role of neuromodulation [89].

Neuroplasticity generally refers to any adaptation process within the functional and structural aspects of the nervous system [10]. Neuroplasticity-related changes vary between healthy individuals compared to those with injuries or diseases and can be either adaptive or maladaptive in nature. Functional imaging, such as functional magnetic resonance imaging (fMRI), has been investigated extensively as a means to monitor and guide neuroplasticity-related recovery in rehabilitation [11]. Similar studies have expanded the multimodal imaging scope to include electro-encephalography (EEG) and magneto-encephalography (MEG) among others [1213]. Neuromodulation is increasingly being studied in terms of the ability to modulate neuroplasticity changes in the brain [4]. Neuromodulation through prolonged translingual stimulation has been shown to positively improved rehabilitation treatment outcomes, particularly balance and gait impairments, following brain injury [41415].

In 2006, Captain (retired) Trevor Greene (TG) was attacked by a young male with an axe when on tour in Afghanistan and survived a severe open TBI. In 2016, D’Arcy et al. reported initial findings from an on-going investigation of TG’s unprecedented long-term motor recovery [16]. The overall objective continues to focus on pushing the limits of rehabilitation through neuroimaging and neurotechnology. TG’s injury largely involved motor function, with the axe impact damage extending along the axis of the mid-sagittal plane affecting frontal and parietal gray and white matter tissue, transecting the body of the corpus callosum (details below). TG’s rehabilitation objective involves recovering walking abilities, along with other movement-related impairments (e.g., rowing, as a former elite rower).

D’Arcy et al. [16] used longitudinal fMRI to monitor upper and lower limb motor activation recovery four times a year over three years (12 times total). Compared to a control, there was a statistically significant 5× increase in the extent of lower limb motor activation from the beginning of Year 1 to the end of Year 3. TG recovered clinically in parallel, as measured by movement abilities over the study duration, with the clinical scores correlating significantly to increased fMRI motor activation. Importantly, the findings were the first to utilize functional neuroimaging in order to demonstrate neuroplasticity-related recovery well beyond the conventionally adopted time limits (i.e., 6-months to 1 year). In TG’s case, rehabilitation progress had continued for more than six years post-injury, as measured by fMRI, at the time of the study.

Current study overview

Since the 2016 study, TG has continued daily rehabilitation, but has experienced an extended plateau in the recovery of further abilities. In 2018, the current follow-up study began with the specific goal of investigating whether non-invasive neuromodulation, when paired with continuing rehabilitation, could help overcome the plateau and further push the limits of the recovery beyond 12+ years post-injury.

The study utilized translingual neurostimulation (TLNS) through the Portable Neuromodulation Stimulator (PoNS®; Helius Medical Technologies, Newtown, PA), a Health Canada Class II approved medical device that applies sequenced, non-invasive stimulation to the tongue. TLNS stimulation is generally believed to involve the trigeminal (CN-V) and facial (CN-VII) cranial nerves [17]. TLNS came to public attention in the book The Brain That Changes Itself [9]. The stimulation is hypothesized to converge on and modulate visual, vestibular, nociceptive, and visceral sensory signals through bottom-up cerebellar and brainstem pathways to produce neuromodulation effects [17,18,19]. There is initial evidence that stimulation of the trigeminal nerve activates networks involving sensorimotor and cognitive functions, with the possibility that the neuromodulation positively improves symptoms from various pathologies [20].

When paired with intensive physiotherapy (PT) in a multi-centre clinical trial, TLNS stimulation at both high- and low- frequency stimulation levels resulted in significant balance and gait improvements in mild-to-moderate TBI patients, with previous chronic refractory impairments [2122]. Subsequent examination of high- and low- frequency TLNS levels using high-density electroencephalography (EEG), healthy control, within-subjects, cross-over design, showed significant increases in alpha, theta, and attention-related spatial activity as well as a secondary intensity level exposure effect [23]. These recent results, in combination with several other prior related studies, have highlighted the need for functional neuroimaging to characterize the links between clinical effects and the underlying mechanisms of neuromodulation.

Given direct translingual stimulation of neurophysiological processes, magneto-encephalography (MEG) is an important neuroimaging modality because it enables spatio-temporal characterization of neural activation. In order to characterize single-subject PT-related improvements compared to translingual contributions to recovery, it is important to collect clinical and neuroimaging evidence over an extended PT plateau period (i.e., baseline) and then during the treatment onset of translingual neuromodulation (i.e., treatment). By comparing clinical and EEG measures of movement/motor improvements to MEG activation results, it is possible to evaluate the relative contribution of neuromodulation to neuroplasticity-related changes at the cortical level.

Objectives and hypotheses

The objective of the current study was to characterize MEG changes related to motor function while TG underwent intensive PT alone for approximately one-year and then after TLNS was introduced for a 14-week trial period. MEG results were compared to both clinical and EEG measures of improvement.

Hypotheses: We hypothesized that PT + TLNS would lead to significant clinical improvements in movement abilities and that these would correspond to cortical network-level changes in MEG activation, as a function of neuroplasticity. MEG results were evaluated and confirmed using both contrast- and data-driven analyses to test for significant activation changes during the PT + TLNS period. A common trend in function was hypothesized to occur across all measures, showing no-significant change over the extended baseline of intensive PT alone, with an improvement during the intensive PT + TLNS period.[…]

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Fig. 3 MEG activation changes and bootstrapped Z-score plots for right hand movement over baseline (B1, B2, B3) and treatment (T4, T5) time points, revealing convergent activation results across all contrasts and data driven analyses. Top left: Timed Stand contrast-driven PLS. Top right: FIST contrast-driven PLS. Bottom left: Motor EEG contrast-driven PLS. Bottom right: data-driven PLS. Central Sulcus region is shaded for reference. *p < 0.05, **p < 0.01

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[ARTICLE] Effectively Quantifying the Performance of Lower-Limb Exoskeletons Over a Range of Walking Conditions – Full Text

Exoskeletons and other wearable robotic devices have a wide range of potential applications, including assisting patients with walking pathologies, acting as tools for rehabilitation, and enhancing the capabilities of healthy humans. However, applying these devices effectively in a real-world setting can be challenging, as the optimal design features and control commands for an exoskeleton are highly dependent on the current user, task and environment. Consequently, robust metrics and methods for quantifying exoskeleton performance are required. This work presents an analysis of walking data collected for healthy subjects walking with an active pelvis exoskeleton over three assistance scenarios and five walking contexts. Spatial and temporal, kinematic, kinetic and other novel dynamic gait metrics were compared to identify which metrics exhibit desirable invariance properties, and so are good candidates for use as a stability metric over varying walking conditions. Additionally, using a model-based approach, the average metabolic power consumption was calculated for a subset of muscles crossing the hip, knee and ankle joints, and used to analyse how the energy-reducing properties of an exoskeleton are affected by changes in walking context. The results demonstrated that medio-lateral centre of pressure displacement and medio-lateral margin of stability exhibit strong invariance to changes in walking conditions. This suggests that these dynamic gait metrics are optimised in human gait and are potentially suitable metrics for optimising in an exoskeleton control paradigm. The effectiveness of the exoskeleton at reducing human energy expenditure was observed to increase when walking on an incline, where muscles aiding in hip flexion were assisted, but decrease when walking at a slow speed. These results underline the need for adaptive control algorithms for exoskeletons if they are to be used in varied environments.

1. Introduction

Increasingly, exoskeletons are being used to great effect for the rehabilitation of people with lower-limb pathologies (Dollar and Herr, 2008). Additionally, exoskeletons are being developed as assistive tools to reduce the metabolic cost of walking, with some recent advances in state-of-the-art soft exosuits (Panizzolo et al., 2016) demonstrating energy savings of more than 20% (Quinlivan et al., 2017). However, exoskeletons used for these purposes are largely restricted to supervised clinical or research settings, where time and care is taken to ensure that the behaviour of the exoskeleton and the nature of the rehabilitation or assistive regime is well-suited to the subject in question (Wolff et al., 2014). The use of exoskeletons in a real-world setting, e.g. to assist the elderly in everyday life, is made difficult by the number of variables to consider as a human walks in an uncontrolled environment — for example, walking speed, or whether the subject is walking on an incline. Each of these variables can affect the gait pattern of an individual, and therefore the optimal torques to be applied by an assistive device. If exoskeletons are to become widely used devices outside of a clinical setting it is important that a suitable control paradigm is developed that, either implicitly or explicitly, applies assistance that accounts for these variables.

Current control paradigms frequently use normalised kinematic trajectories (Riener et al., 2010), muscle amplification (Ferris and Lewis, 2009), or finite state controllers (Blaya and Herr, 2004). The respective issues with these paradigms are that the kinematic trajectory might not be appropriate for the user’s task or their environment, the muscle firing patterns may be abnormal, and there are a large number of parameters to tune.

It is known that the human neuromuscular system optimises stability (Kuo and Donelan, 2010). By studying the effect of different walking contexts and constant perturbations (applied via an exoskeleton) on healthy walking, it is posited that there will be an underlying invariant metric that reflects the optimisation of the stability of human gait. Once identified, this metric can then be optimised as part of an exoskeleton control paradigm which provides assistance while maintaining balance, implicitly accounting for the effects of changing walking context and varying exoskeleton assistance. Previous work has been carried out to determine what effect walking speed (Winter, 1984Stansfield et al., 2001Orendurff et al., 2004), the environment (Lay et al., 2006Franz and Kram, 2012), and exoskeleton forces have (Lewis and Ferris, 2011Lenzi et al., 2012Martelli et al., 2014) on a user’s gait but these are constrained by using limited metrics and, for the work done on exoskeletons, limited walking contexts.

The human neuromuscular system also optimises energy efficiency (Kuo and Donelan, 2010). In a similar analysis to what is outlined above, the effect of different walking contexts and exoskeleton forces on healthy walking can be measured in terms of the metabolic energy consumed by the muscles of the subject. This relationship could be optimised as part of a model-based exoskeleton control paradigm, alongside a stability metric, where the aim is to reduce total human energy expenditure or, alternatively, target specific groups of muscles for rehabilitation or assistance. Once known, this relationship can be used to inform how exoskeleton controllers are implemented for use in real-world settings where steady, flat walking is not guaranteed.

In this study, a neuromuscular human and exoskeleton model is presented. Experimental data was collected using a unique setup, combining kinematic, kinetic, and exoskeleton angular and torque data. Using this data, stability metrics and metabolic energy consumption were compared between three walking scenarios: walking without an exoskeleton, walking with an exoskeleton in transparent mode, and walking with an exoskeleton in assistive mode. For each of these scenarios five different walking contexts were investigated: walking at baseline speed, walking up an incline, walking down an incline, fast walking, and slow walking. To carry out the analysis a range of spatial and temporal, kinematic, kinetic, and dynamic gait metrics (such as centre of mass displacement) were selected.. The selected metrics were compared to identify those which demonstrated the most invariance and therefore would be suitable for optimising in an exoskeleton control paradigm. In addition, metabolic energy consumption was calculated and is reported for a subset of muscles crossing the hip, knee and ankle joints, and the effect of variations in walking context and exoskeleton assistance level on these representative muscles is discussed.

2. Material and Methods

2.1. Model Development

The exoskeleton which we use to provide assistance is the Active Pelvis Orthosis (APO), a revised version of the device presented by Giovacchini et al. (Giovacchini et al., 2015) (see Figure 1A). This exoskeleton was developed at The BioRobotics Institute of Scuola Superiore Sant’Anna (Pisa, Italy); the technology is currently licensed to IUVO Srl (http://www.iuvo.company, Pontdera, Italy). The APO provides a force applied to the thighs of the user transmitted via two carbon fibre lateral arms which are actuated by series elastic actuation units.

Figure 1(A) The Active Pelvis Orthosis (APO). (B) An overview of the APO OpenSim model’s constraints, bodies, and degrees of freedom: (1) APO backpack, (2) Weld constraint between APO backpack and pelvis, (3) right APO group body (houses the actuators), (4) APO free joint (6 DOF), (5) right APO link, (6) weld constraint between APO link and femur. (C) The experimental setup. This image is published with the written informed consent of the depicted individual. ©IEEE 2017

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[Abstract] A Multi-Functional Lower-and Upper-Limb Stroke Rehabilitation Robot

Abstract

It is estimated that about 15 million people a year suffer from stroke worldwide, with 5 million stroke survivors experiencing permanent motor disability requiring therapeutic services. It has been shown that early involvement in rehabilitation therapies has a desirable effect on the long-term recovery of patients. There are, however, several challenges with the current state of delivering rehabilitation services, including limitations on the number of clinics, financial needs, and human resources. Robotic systems have been proposed in the literature to help with these challenges. However, most of the existing robotic systems are expensive, not-portable, and cannot be used for both upper-and lower-limb rehabilitation. This paper presents a 3-DOF robotic device that has been designed to deliver both upper-and lower-limb therapy and incorporates a novel mechanical safety mechanism. The device is capable of teleoperation which makes it particularly suitable for telerehabilitation in the current COVID-19 environment. The rehabilitation robot can deliver therapy in assistive and resistive modes to aid patients at all stages of recovery. In the assistive mode, the robot’s motion provides input to help the patient in completing the therapy task, while in the resistive mode, the robot opposes the motions generated by the patient thereby requiring additional muscle actuation. The robot has been tested by physiotherapists to assess its validity in a clinical setting, and by healthy participants to assess its functionality, safety, and engineering design. The study found that 80physiotherapists agreed the platform has the potential to improve patient outcomes.

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[ARTICLE] Perspectives on the prospective development of stroke-specific lower extremity wearable monitoring technology: a qualitative focus group study with physical therapists and individuals with stroke – Full Text

Abstract

Background

Wearable activity monitors that track step count can increase the wearer’s physical activity and motivation but are infrequently designed for the slower gait speed and compensatory patterns after stroke. New and available technology may allow for the design of stroke-specific wearable monitoring devices, capable of detecting more than just step counts, which may enhance how rehabilitation is delivered. The objective of this study was to identify important considerations in the development of stroke-specific lower extremity wearable monitoring technology for rehabilitation, from the perspective of physical therapists and individuals with stroke.

Methods

A qualitative research design with focus groups was used to collect data. Five focus groups were conducted, audio recorded, and transcribed verbatim. Data were analyzed using content analysis to generate overarching categories representing the stakeholder considerations for the development of stroke-specific wearable monitor technology for the lower extremity.

Results

A total of 17 physical therapists took part in four focus group discussions and three individuals with stroke participated in the fifth focus group. Our analysis identified four main categories for consideration: 1) ‘Variability’ described the heterogeneity of patient presentation, therapy approaches, and therapeutic goals that are taken into account for stroke rehabilitation; 2) ‘Context of use’ described the different settings and purposes for which stakeholders could foresee employing stroke-specific wearable technology; 3) ‘Crucial design features’ identified the measures, functions, and device characteristics that should be considered for incorporation into prospective technology to enhance uptake; and 4) ‘Barriers to adopting technology’ highlighted challenges, including personal attitudes and design flaws, that may limit the integration of current and future wearable monitoring technology into clinical practice.

Conclusions

The findings from this qualitative study suggest that the development of stroke-specific lower extremity wearable monitoring technology is viewed positively by physical therapists and individuals with stroke. While a single, specific device or function may not accommodate all the variable needs of therapists and their clients, it was agreed that wearable monitoring technology could enhance how physical therapists assess and treat their clients. Future wearable devices should be developed in consideration of the highlighted design features and potential barriers for uptake.

Background

Individuals with stroke commonly face mobility limitations, beginning at stroke onset [1] and continuing past discharge into the community [2], and demonstrate a range of gait deviations due to altered motor control and resulting compensatory movement patterns [3]. Improving walking quality and quantity is a major focus of therapy [4], as doing so can improve mobility, fitness, quality of life, and prevent secondary complications [56]. One avenue to target walking for individuals with stroke may be to utilize wearable monitoring technology, as previous research has shown that application of an activity monitor can improve user self-efficacy and physical activity levels in various patient populations including older adults, breast cancer survivors, and those with chronic obstructive pulmonary disease [7,8,9,10,11]. Additionally, wearable monitors have been increasingly utilized by therapists and researchers to assess various outcomes relating to exercise and physical activity, [1213] within therapy and between visits, to ensure exercise targets are met [14].

The majority of currently available wearable monitoring technology has not been developed specifically for stroke-related impairments and movement patterns. For example, consumer activity monitors are often limited by a minimum walking speed or movement amplitude in order to provide accurate and reliable feedback [1516]. Research efforts have attempted to adapt available wearable monitoring technology to meet the needs of individuals with stroke with increasing accuracy, from simple solutions such as wearing hip-situated fitness trackers at the ankle [1718], to developing software algorithms to analyze captured data to recognize movements patterns specific to stroke [19,20,21]. The advances in wearable monitoring have reached a point at which designing stroke-specific wearable monitoring technology is a realistic priority to assess outcome and enhance rehabilitation interventions [22].

Much of the efforts to design stroke-specific wearable monitoring technology has so far focused on the hemiparetic upper limb [23,24,25,26]. This is unsurprising, as many individuals with stroke report long-term upper limb deficits or disability [27], and upper limb recovery has been identified as a top research priority from the perspective of individuals with stroke and their health professionals [28]. Conversely, limited efforts have been made in applying sensing technology to design stroke-specific wearable monitors for the hemiparetic lower limb. Research has shown that accelerometry can be reliable and valid in measuring physical activity after stroke [29], and new technologies to quantify foot pressure, leg motion, and muscle activity are being shown to be applicable to stroke [3031]. Thus, there is a gap in wearable monitoring technology for individuals with stroke, between what can be designed to improve rehabilitation of the lower extremity and what is currently available.

In order to develop devices that fill this niche, it is important to involve end-users in the development process from the onset to ensure initial efforts are relevant to the individuals who will ultimately use them, [3233] which inevitably are individuals with stroke and their physical therapists. This user-centered design approach is optimal for identifying relevant factors and technical aspects that should inform design choices [3233]. Thus, the objective of the current study was to identify important considerations in the future development of stroke-specific lower extremity wearable monitoring technology for rehabilitation, from the perspective of physical therapists and individuals with stroke.[…]

 

Continue —->  Perspectives on the prospective development of stroke-specific lower extremity wearable monitoring technology: a qualitative focus group study with physical therapists and individuals with stroke | Journal of NeuroEngineering and Rehabilitation | Full Text

 

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[NEWS] Botox is Now Approved for Lower-Limb Spasticity in Children

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The US Food and Drug Administration (FDA) has approved onabotulinumtoxinA (Botox, Allergan) to ease lower-limb spasticity in children and adolescents aged 2 years to 17 years, excluding spasticity caused by cerebral palsy (CP), Allergan announces.

“Lower limb spasticity can impact many aspects of a child’s life and have a drastic influence on their overall development and quality of life,” David Nicholson, Allergan’s chief research and development officer, says in a news release.

The FDA approved Botox for lower-limb spasticity on the basis of safety and efficacy data from a phase 3 study involving more than 300 children aged 2 years or older with lower-limb spasticity.

Participants in the trial had CP, but the approved indication excludes lower-limb spasticity caused by CP, owing to marketing exclusivity by another company, according to Allergan.

The approved recommended dose per treatment session is 4 to 8 units/kg divided among affected muscles of the lower limb. The total dose for pediatric patients should not exceed 8 units/kg body weight, or 300 units, whichever is lower.

When treating both lower limbs or upper and lower limbs in combination, the total dose for pediatric patients should not exceed 10 units/kg, or 340 units, whichever is lower, in a 3-month interval, the company states.

“Pediatric lower limb spasticity inhibits normal muscular movement and function and can result in delayed or impaired motor development, as well as difficulty with posture and positioning,” Mark Gormley, Jr, MD, of Gillette Children’s Specialty Healthcare–St. Paul, comments, in the release.

“Botox has a well-established safety and efficacy profile, and supports children and adolescents successfully manage both their upper and lower limb spasticity,” said Gormley.

Botox was approved for pediatric upper-limb spasticity in June.

[Source: Medscape]

 

via Botox is Now Approved for Lower-Limb Spasticity in Children – Rehab Managment

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[WEB SITE] Transcutaneous electrical stimulation (TENS) may help lower limb spasticity after stroke

Adult using TENS machine for lower limb pain

Published on 26 February 2019

doi: 10.3310/signal-000738

Transcutaneous electrical stimulation (TENS) delivered alongside standard physical therapies could reduce spasticity in the lower limbs following a stroke.

Spasticity is a muscle control disorder characterised by tight muscles. It is common after stroke and accounts for significant disability. TENS is often used to treat pain and can affect nervous stimulation of the muscles.

The main evidence in this systematic review came from five trials which suggested that TENS combined with other physical therapies has moderate effect on lower limb spasticity compared with placebo.

The review has limitations, with small studies and little evidence on use for upper limbs or comparing with other therapies. However, TENS machines are portable, inexpensive and widely accessible making them an appealing addition to other care.

NICE does not currently recommend the use of TENS in stroke rehabilitation, though guidance covers use of other types of electrical stimulation in certain other contexts.

Why was this study needed?

More than 1.2 million people in the UK are living with the effects of stroke. About two-thirds of stroke survivors leave hospital with residual disability and one quarter experience spasticity.

Electrical stimulation is sometimes used as treatment after a stroke. It includes functional electrical stimulation and neuromuscular electrical stimulation, which both focus on muscle contraction. Transcutaneous electrical stimulation (TENS) targets the sensory nerves in a different way.

Transcutaneous electrical stimulation has been suggested as an adjunct to other rehabilitation therapy to try and reduce spasticity. The device is portable and can be self-administered at home, so its potential for managing spasticity is appealing.

There have been a number of small studies of TENS with conflicting results. This review aimed to combine the results to see if there was evidence for its use to treat spasticity after stroke.

What did this study do?

This systematic review identified 15 studies (10 randomised controlled trials) reporting the effectiveness of TENS on spasticity after stroke.

Studies compared TENS, used alone or alongside other therapies such as functional exercises, with placebo, no treatment or other treatments. Thirteen studies assessed lower limb spasticity, with 11 targeting the ability to flex the foot. Most assessed use in the chronic rather than acute phase of stroke.

Transcutaneous electrical stimulation regimen varied widely. Intervention periods ranged from one day to 12 weeks, the number of TENS sessions from one to seven per week, and the duration of sessions ranged from less than 20 minutes up to 60 minutes.

Trials were small with maximum participant size 80. The quality of randomised controlled trials was good overall, with lack of participant blinding being the most likely source of bias. Seven trials were pooled in meta-analysis.

What did it find?

  • Transcutaneous electrical stimulation used alongside other physical therapies was moderately effective in reducing spasticity in the lower limbs compared with placebo (standard mean difference [SMD] -0.64, 95% confidence interval [CI] -0.98 to -0.31). This was from meta-analysis of five trials (221 adults) with broadly similar results.
  • Pooled results of two trials (60 adults) also found that TENS alongside other physical therapies was more effective at reducing spasticity than no TENS (SMD -0.83, 95% CI -1.51 to -0.15).
  • Five studies assessed longer-term effects on spasticity. Three studies found the effects were maintained for a period of two to five weeks whilst two studies found the effects lasted for less than a day and that spasticity returned to baseline levels immediately following the intervention.
  • None of the studies reported any adverse effects of TENS.

What does current guidance say on this issue?

The NICE guideline on stroke rehabilitation (2013) does not currently include recommendations for use of TENS. NICE advises against the routine use of electrical stimulation for the hand and arm but suggests a trial of treatment may be considered if there is sign of muscle contraction, and the person cannot move their arm against resistance.

NICE guidance from 2009 advises that there is sufficient evidence that functional electrical stimulation can improve walking in people with drop foot following a stroke, provided the normal arrangements are in place for clinical governance, consent and audit.

What are the implications?

This review suggests that TENS, when delivered alongside other physical therapies, could be considered for lower limb spasticity as part of a stroke rehabilitation programme.

The findings are similar to a 2015 systematic review which found that electrical stimulation gave small but significant improvements in spasticity following stroke. Again this earlier review was limited by small sample sizes, varied treatment regimens and few studies that could be pooled in meta-analysis.

There was insufficient evidence to support use for upper limbs.

Cost was not assessed, but TENS is a non-invasive therapy and devices are widely available and could easily be used at home.

Citation and Funding

Mahmood A, Veluswamy SK, Hombali A, et al. Effect of transcutaneous electrical nerve stimulation on spasticity in adults with stroke: a systematic review and meta-analysis. Arch Phys Med Rehabil. 2018; 16 November. doi: 10.1016/j.apmr.2018.10.016. [Epub ahead of print].

No funding information was provided for this study.

Bibliography

NICE. Functional electrical stimulation for drop foot of central neurological origin. IPG278. London: National Institute for Health and Care Excellence; 2009.

NICE. Stroke rehabilitation in adults. CG162. London: National Institute for Health and Care Excellence; 2013.

NICE. Spasticity (after stroke) – botulinum toxin type A. ID768. London: National Institute for Health and Care Excellence; in development.

Stein C, Fritsch CG, Robinson C et al. Effects of electrical stimulation in spastic muscles after stroke: systematic review and meta-analysis of randomized controlled trials. Stroke. 2015;46(8):2197-205.

Stroke Association. State of the nation: stroke statistics. London: Stroke Association; 2018.

 

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  2. Transcutaneous Electrical Stimulation
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[ARTICLE] Experiences of treadmill walking with non-immersive virtual reality after stroke or acquired brain injury : A qualitative study – Full Text

Abstract

Objectives

It is well known that physical activity levels for persons after stroke or acquired brain injuries do not reach existing recommendations. Walking training is highly important since the ability to walk is considered to be a meaningful occupation for most people, and is often reduced after a brain injury. This suggests a need to innovate stroke rehabilitation, so that forms of walking training that are user-friendly and enjoyable can be provided.

Method

An interview study was carried out with persons after stroke (n = 8), or acquired brain injury (n = 2) at a rehabilitation unit at Sahlgrenska University Hospital. We used a semi-structured interview guide to investigate experiences and thoughts about walking on a treadmill with non-immersive virtual reality feedback. The contents were analyzed through an inductive approach, using qualitative content analysis.

Results

The virtual reality experience was perceived as enjoyable, exciting, and challenging. Participants stressed that the visual and auditory feedback increased their motivation to walk on a treadmill. However, for some participants, the virtual reality experience was too challenging, and extreme tiredness or fatigue were reported after the walking session.

Conclusions

Participants’ thoughts and experiences indicated that the Virtual Reality walking system could serve as a complement to more traditional forms of walking training. Early after a brain injury, virtual reality could be a way to train the ability to handle individually adapted multisensory input while walking. Obvious benefits were that participants perceived it as engaging and exciting.

Introduction

In general, physical activity levels in rehabilitation units are low [] and do not reach the recommendations for persons with stroke or acquired brain injury (ABI) []. There are also indications that the intensity of physiotherapy sessions after stroke is mostly at low levels []. Several barriers may contribute to inactivity, such as neurological deficits, cognitive impairment, environmental factors, and lack of motivation [].

A dose-response effect on exercise outcome after stroke has been shown, and training should be highly repetitive and task oriented []. Walking training is important and considered to be a meaningful occupation for most people. To increase walking exercise intensity, treadmill walking has been proposed as a means of task-oriented training that gives the opportunity for many repetitions, and has shown to promote a more normal walking pattern []. Walking on a moving surface like a treadmill is more demanding than walking on the ground in terms of sensory processing, postural control and movement coordination. From a motivational perspective, treadmill walking may be perceived as boring the long run.

Training of goal-specific activities with a high number of repetitions may be offered using virtual reality (VR) applications, which have been introduced in neurological rehabilitation []. Training using VR has also been suggested to enhance neuroplasticity after stroke [] by means of offering multisensory stimulation at a high intensity. VR comprises computer-based real-time simulation of an environment with user interaction [] visually displayed on a screen or through head-mounted devices. Differences in technology and visual presentations in 2D or 3D enable varying types of feedback, levels of immersion and sense of presence in the virtual environment []. VR feedback can be mediated through vision, hearing, touch, movement, or smell. The technique provides performance feedback–both directly experienced and objectively quantified, and may thereby increase exercise motivation, and improve motor performance [].

Following stroke, VR training has been mostly described for the upper limb but also for the lower limb; balance and walking as well as for perceptual/cognitive skills []. VR has shown a potential for positive effects on walking and balance abilities, although the number of studies are low and the evidence for its superiority to other methods is low [].

Although few adverse events from VR training have been described, some participants have reported headache or dizziness [] and knowledge is lacking regarding how persons affected by brain injuries perceive the exposure of multisensory input, during a complex activity such as treadmill walking with VR. The potential effects on motivation and participant experience of VR are scarcely investigated [] and mostly focused on upper limb activities and games []. Based on this, we wanted to investigate patients’ overall experiences of a VR concept in walking training.

The aim of the present study was to explore the experiences of VR in addition to walking on a treadmill in persons with stroke or acquired brain injuries. Participants’ overall experiences and suggestions for development of the exercise method were areas of interest.[…]

 

Continue —>  Experiences of treadmill walking with non-immersive virtual reality after stroke or acquired brain injury – A qualitative study

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