Posts Tagged upper limb spasticity
[ARTICLE] Effectiveness of Robot-Assisted Upper Limb Training on Spasticity, Function and Muscle Activity in Chronic Stroke Patients Treated With Botulinum Toxin: A Randomized Single-Blinded Controlled Trial
Background: The combined use of Robot-assisted UL training and Botulinum toxin (BoNT) appear to be a promising therapeutic synergism to improve UL function in chronic stroke patients.
Objective: To evaluate the effects of Robot-assisted UL training on UL spasticity, function, muscle strength and the electromyographic UL muscles activity in chronic stroke patients treated with Botulinum toxin.
Methods: This single-blind, randomized, controlled trial involved 32 chronic stroke outpatients with UL spastic hemiparesis. The experimental group (n = 16) received robot-assisted UL training and BoNT treatment. The control group (n = 16) received conventional treatment combined with BoNT treatment. Training protocols lasted for 5 weeks (45 min/session, two sessions/week). Before and after rehabilitation, a blinded rater evaluated patients. The primary outcome was the Modified Ashworth Scale (MAS). Secondary outcomes were the Fugl-Meyer Assessment Scale (FMA) and the Medical Research Council Scale (MRC). The electromyographic activity of 5 UL muscles during the “hand-to-mouth” task was explored only in the experimental group and 14 healthy age-matched controls using a surface Electromyography (EMGs).
Results: No significant between-group differences on the MAS and FMA were measured. The experimental group reported significantly greater improvements on UL muscle strength (p = 0.004; Cohen’s d = 0.49), shoulder abduction (p = 0.039; Cohen’s d = 0.42), external rotation (p = 0.019; Cohen’s d = 0.72), and elbow flexion (p = 0.043; Cohen’s d = 1.15) than the control group. Preliminary observation of muscular activity showed a different enhancement of the biceps brachii activation after the robot-assisted training.
Conclusions: Robot-assisted training is as effective as conventional training on muscle tone reduction when combined with Botulinum toxin in chronic stroke patients with UL spasticity. However, only the robot-assisted UL training contributed to improving muscle strength. The single-group analysis and the qualitative inspection of sEMG data performed in the experimental group showed improvement in the agonist muscles activity during the hand-to-mouth task.
Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT03590314
Upper limb (UL) sensorimotor impairments are one of the major determinants of long-term disability in stroke survivors (1). Several disturbances are the manifestation of UL impairments after stroke (i.e., muscle weakness, changes in muscle tone, joint disturbances, impaired motor control). However, spasticity and weakness are the primary reason for rehabilitative intervention in the chronic stages (1–3). Historically, spasticity refers to a velocity-dependent increase in tonic stretch reflexes with exaggerated tendon jerks resulting from hyperexcitability of the stretch reflex (4) while weakness is the loss of the ability to generate the normal amount of force.
From 7 to 38% of post-stroke patients complain of UL spasticity in the first year (5). The pathophysiology of spasticity is complicated, and new knowledge has progressively challenged this definition. Processes involving central and peripheral mechanisms contribute to the spastic movement disorder resulting in abnormal regulation of tonic stretch reflex and increased muscle resistance of the passively stretched muscle and deficits in agonist and antagonist coactivation (6, 7). The resulting immobilization of the muscle at a fixed length for a prolonged time induces secondary biomechanical and viscoelastic properties changes in muscles and soft tissues, and pain (8–11). These peripheral mechanisms, in turn, leads to further stiffness, and viscoelastic muscle changes (2, 8). Whether the muscular properties changes may be adaptive and secondary to paresis are uncertain. However, the management of UL spasticity should combine treatment of both the neurogenic and peripheral components of spasticity (9, 10).
UL weakness after stroke is prevalent in both acute and chronic phases of recovery (3). It is a determinant of UL function in ADLs and other negative consequences such as bone mineral content (3), atrophy and altered muscle pattern of activation. Literature supports UL strengthening training effectiveness for all levels of impairment and in all stages of recovery (3). However, a small number of trials have been performed in chronic subgroup patients, and there is still controversy in including this procedure in UL rehabilitation (3).
Botulinum toxin (BoNT) injection in carefully selected muscles is a valuable treatment for spastic muscles in stroke patients improving deficits in agonist and antagonist coactivation, facilitating agonist recruitment and increasing active range of motion (6–8, 12–14). However, improvements in UL activity or performance is modest (13). With a view of improving UL function after stroke, moderate to high-quality evidence support combining BoNT treatment with other rehabilitation procedures (1, 9, 15). Specifically, the integration of robotics in the UL rehabilitation holds promise for developing high-intensity, repetitive, task-specific, interactive treatment of upper limb (15). The combined use of these procedures to compensate for their limitations has been studied in only one pilot RCT reporting positive results in UL function (Fugl-Meyer UL Assessment scale) and muscular activation pattern (16). With the limits of the small sample, the results support the value of combining high-intensity UL training by robotics and BoNT treatment in patients with UL spastic paresis.
Clinical scales are currently used to assess the rehabilitation treatment effects, but these outcome measures may suffer from some drawbacks that can be overcome by instrumental assessment as subjectivity, limited sensitivity, and the lack of information on the underlying training effects on motor control (17). Instrumental assessment, such as surface electromyography (sEMG) during a functional task execution allows assessing abnormal activation of spastic muscles and deficits of voluntary movements in patients with stroke.
Moreover, the hand-to-mouth task is representative of Activities of Daily Life (ADL) such as eating and drinking. Kinematic analysis of the hand-to-mouth task has been widely used to assess UL functions in individuals affected by neurological diseases showing adequate to more than adequate test-retest reliability in healthy subjects (18, 19). The task involves flexing the elbow a slightly flexing the shoulder against gravity, and it is considered to be a paradigmatic functional task for the assessment of spasticity and strength deficits on the elbow muscles (17, 20). Although sEMG has been reported to be a useful assessment procedure to detect muscle activity improvement after rehabilitation, limited results have been reported (16, 21).
The primary aim of this study was to explore the therapeutic synergisms of combined robot-assisted upper limb training and BoNT treatment on upper limb spasticity. The secondary aim was to evaluate the treatment effects on UL function, muscle strength, and the electromyographic activity of UL muscles during a functional task.
The combined treatment would contribute to decrease UL spasticity and improve function through a combination of training effects between BoNT neurolysis and the robotic treatment. A reduction of muscle tone would parallel improvement in muscle strength ought to the high-intensity, repetitive and task-specific robotic training. Since spasticity is associated with abnormal activation of shortening muscles and deficits in voluntary movement of the UL, the sEMG assessment would target these impairments (2, 8–11, 15).
Materials and Methods
A single-blind RCT with two parallel group is reported. The primary endpoint was the changes in UL spasticity while the secondary endpoints were changes in UL function, muscle strength and the electromyographic activity of UL muscles during a functional task. The study was conducted according to the tenets of the Declaration of Helsinki, the guidelines for Good Clinical Practice, and the Consolidated Standards of Reporting Trials (CONSORT), approved by the local Ethics Committee “Nucleo ricerca clinica–Research and Biostatistic Support Unit” (prog n.2366), and registered at clinical trial (NCT03590314).
Chronic post-stroke patients with upper-limb spasticity referred to the Neurorehabilitation Unit (AOUI Verona) and the Physical Medicine and Rehabilitation Section, “OORR” Hospital (University of Foggia) were assessed for eligibility.
Inclusion criteria were: age > 18 years, diagnosis of ischemic or hemorrhagic first-ever stroke as documented by a computerized tomography scan or magnetic resonance imaging, at least 6 months since stroke, Modified Ashworth Scale (MAS) score (shoulder and elbow) ≤ 3 and ≥1+ (22), BoNT injection within the previous 12 weeks of at least one of muscles of the affected upper limb, Mini-Mental State Examination (MMSE) score ≥24 (23) and Trunk Control Test score = 100/100 (24).
Exclusion criteria were: any rehabilitation intervention in the 3 months before recruitment, bilateral cerebrovascular lesion, severe neuropsychologic impairment (global aphasia, severe attention deficit or neglect), joint orthopedic disorders.
All participants were informed regarding the experimental nature of the study. Informed consent was obtained from all subjects. The local ethics committee approved the study.
Each patient underwent a BoNT injection in the paretic limb. The dose of BoNT injected into the target muscle was based on the severity of spasticity in each case. Different commercial formulations of BoNT were used according to the pharmaceutical portfolio contracts of our Hospitals (Onabotulinumtoxin A, Abobotulinumtoxin A, and Incobotulinumtoxin A). The dose, volume and number of injection sites were set accordingly. A Logiq ® Book XP portable ultrasound system (GE Healthcare; Chalfont St. Giles, UK) was used to inject BoNT into the target muscle.
Before the start of the study authors designed the experimental (EG) and the control group (CG) protocols. Two physiotherapists, one for each group, carried out the rehabilitation procedures. Patients of both groups received ten individual sessions (45 min/session, two sessions/week, five consecutive weeks). Treatments were performed in the rehabilitative gym of the G. B. Rossi University Hospital Neurological Rehabilitation Unit, or “OORR” Hospital.
Robot-Assisted UL Training
The Robot-assisted UL Training group was treated using the electromechanical device Armotion (Reha Technology, Olten, Switzerland). It is an end-effector device that allows goal-directed arm movements in a bi-dimensional space with visual feedback. It offers different training modalities such as passive, active, passive-active, perturbative, and assistive modes. The robot can move, drive or oppose the patient’s movement and allows creating a personalized treatment, varying parameters such as some repetitions, execution speed, resistance degree of motion. The exercises available from the software are supported by games that facilitate the functional use of the paretic arm (25). The robot is equipped with a control system called “impedance control” that modulates the robot movements for adapting to the motor behavior of the patient’s upper limb. The joints involved in the exercises were the shoulder and the elbow, is the wrist fixed to the device.
The Robot-assisted UL Training consisted of passive mobilization and stretching exercises for affected UL (10 min) followed by robot-assisted exercises (35 min). Four types of exercises contained within the Armotion software and amount of repetitions were selected as follows: (i) “Collect the coins” (45–75 coins/10 min), (ii) “Drive the car” (15–25 laps/10 min), (iii) “Wash the dishes” (40–60 repetitions/10 min), and (iv) “Burst the balloons” (100–150 balloons/5 min) (Figure 1). All exercises were oriented to achieving several goals in various directions, emphasizing the elbow flexion-extension and reaching movement. The robot allows participants to execute the exercises through an “assisted as needed” control strategy. For increment the difficulty, we have varied the assisted and non-assisted modality, increasing the number of repetitions over the study period.
The conventional training consisted of UL passive mobilization and stretching (10 min) followed by UL exercises (35 min) that incorporated single or multi-joint movements for the scapula, shoulder, and elbow, performed in different positions (i.e., supine and standing position). The increase of difficulty and progression of intensity were obtained by increasing ROM, repetitions and performing movements against gravity or slight resistance (26). Training parameters were recorded on the patient’s log. […]
Continue —> Effectiveness of Robot-Assisted Upper Limb Training on Spasticity, Function and Muscle Activity in Chronic Stroke Patients Treated With Botulinum Toxin: A Randomized Single-Blinded Controlled Trial
[Review] Gamified In-Home Rehabilitation for Stroke Survivors: Analytical Review – Full Text DOC file
A stroke is a life-changing event that may end up as a disability, with repercussions on the patient’s quality of life. Stroke rehabilitation therapies are helpful to regain some of the patient’s lost functionality. However, in practice stroke patients may suffer from a gradual loss of motivation. Gamified systems are used to increase user motivation, hence, gamified elements have been implemented into stroke rehabilitation therapies in order to improve patients’ engagement and adherence. This review work focuses on selecting and analyzing developed and validated gamified stroke rehabilitation systems published between 2009 and 2017 to identify the most important features of these systems. After extensive research, 32 articles have met the selection criteria, resulting in a total of 28 unique works. The works were analyzed and a total of 20 features were identified. The features are explained, making emphasis on the works that implement them extensively. Finally, a classification of features based on objectives is proposed, which was used to identify the relationships between features and implementation gaps. It was found that there is a tendency to develop low-cost solutions as in-home therapy systems; to include automated features; provide a diversity of games and use of simple interaction devices. This review allowed the definition of the opportunities for future research direction such as systems addressing the three rehabilitation areas; data analytics to make decisions; motivational content identification based on automatic engagement detection and emotion recognition; and alert systems for patient´s safety.
Brain stroke is a life-changing disease that can have fatal consequences. Stroke survivors may end up with long-term disabilities. These disabilities will depend on the damaged part of the brain and the body functions related to it. Older adults are the population with the highest risk of suffering a stroke and ending up with a disability. This makes of stroke the leading cause of adult disability worldwide [1-4].
Stroke rehabilitation therapy has proven to be useful in helping the patient to regain some of his lost functionality [5-8]. In traditional rehabilitation programs, when the rehabilitation in the hospital is completed, the patients return to their homes, where they should continue with more rehabilitation activities. However, the patient’s adherence is reduced at home. The two main causes for this are: the lack of available resources and tools to sustain training for longer periods; and, a diminishing motivation as repetitive exercises are perceived as tedious and boring [9-12]. Gamified rehabilitation systems have proven to be useful to improve motor and cognitive function and additionally as a tool to motivate patients to adhere to the therapy programme [13-22].
This study focuses on gamified systems dedicated for stroke patients’ upper limb rehabilitation for in-home use. The objectives of this study are: 1) provide a literature review of the developed and tested gamified systems for in-home stroke rehabilitation, between 2009 and 2017; 2) identify and explain the most used features of these systems; 3) provide a simple way to classify the features, in order to identify the relationships between them and the gaps of their implementations. A total of 32 articles have met the selection criteria, which resulted in a total of 28 unique works. From analysis of these studies, a total of 20 features were identified. The remaining of this paper is structured as follows. Section 2 describes the methodology used to find the reviewed works and the database to be used, as well as the selection criteria applied to select research works. Section 3 presents the results of the analysis, with the emphasis on the importance of each feature and the works that implemented them to higher extents. An analytical point of view is discussed in Section 4, where an objective-based classification is proposed, the relationships between the features are presented and additionally, the gaps in the current systems are identified. Finally, Section 5 is dedicated for the conclusion and the future research perspectives.[…]
Download Full Text DOC file
[ARTICLE] Effect of early use of AbobotulinumtoxinA after stroke on spasticity progression: Protocol for a randomised controlled pilot study in adult subjects with moderate to severe upper limb spasticity (ONTIME pilot) – Full Text
Approximately 15 million people suffer a stroke annually, up to 40% of which may develop spasticity, which can result in impaired limb function, pain and associated involuntary movements affecting motor control.
Robust clinical data on spasticity progression, associated symptoms development and functional impairment is scarce. Additionally, maximal duration of muscle tone reduction following botulinum toxin type A (BoNT-A) injections remains undetermined. The ONTIME pilot study aims to explore these issues and evaluate whether abobotulinumtoxinA 500 U (Dysport®; Ipsen) administered intramuscularly within 12 weeks following stroke delays the appearance or progression of symptomatic (disabling) upper limb spasticity (ULS).
ONTIME is a 28-week, phase 4, randomised, double-blind, placebo-controlled, exploratory pilot study initiated at four centres across Malaysia, the Philippines, Singapore and Thailand. Subjects (n = 42) with moderate to severe ULS (modified Ashworth scale [MAS] score ≥2) in elbow flexors or pronators, wrist flexors, or finger flexors will be recruited. Subjects will be randomised 2:1 to abobotulinumtoxinA 500 U or placebo (single dose 2–12 weeks after first-ever stroke).
Primary efficacy will be measured by time between initial injection and visit at which reinjection criteria (MAS score ≥2 in the primary targeted muscle group and appearance or reappearance of symptomatic ULS) are met. Follow-up visits will be 4-weekly to a maximum of 28 weeks.
This pilot study will facilitate the design and sample size calculation of further confirmatory studies, and is expected to provide insights into the optimal management of post-stroke patients, including timing of BoNT-A therapy and follow-up duration.
An estimated 15 million people suffer a stroke annually ; of whom, up to 40% develop post-stroke spasticity, a state of velocity-dependent increase in tonic stretch reflexes (‘muscle tone’) with exaggerated tendon jerks  most commonly affecting upper limbs ; ; ;  ; . Post-stroke spasticity impedes active and passive functioning of affected limb(s), impairs activities of daily living and requires long-term treatment; associated healthcare costs are up to four-fold greater than for stroke survivors without spasticity . Furthermore, spasticity may involve pain and involuntary movements, interfering with dressing, gait, balance and walking speed, and can disrupt rehabilitation . Without functional improvement, secondary musculoskeletal complications such as contractures and deformity may develop .
Data on the proportion of patients with post-stroke spasticity developing disability are scarce. One survey (N = 140) reported a prevalence of 17% spasticity and 4% disabling spasticity with a year . Upper limb involvement and age <65 years were associated with disabling spasticity in this study . In other studies, over a third of individuals developed spasticity within a year, including 20% with severe spasticity  ; , suggesting higher rates of disabling spasticity than those reported by Lundström et al. .
Studies evaluating the timeframe for developing spasticity symptoms post-stroke are also few, with small cohorts (around 100 patients), but suggest the prevalence and severity of spasticity increases within a year post-stroke ; ; ; ;  ; . Certain studies indicate that spasticity symptoms and muscle tone changes are apparent in up to 25% of stroke victims within 2 weeks ;  ; . One study reported increased muscle tone as an early risk factor for developing severe disabling spasticity, particularly if it affected more than two joints, or was associated with a modified Ashworth scale (MAS) score ≥2 in one affected joint within 6 weeks post-stroke . Indeed, spasticity may persist , and the severity of upper limb spasticity (ULS) may increase over time, most commonly affecting anti-gravity muscles, during the first 2 weeks and at 3 months post-stroke .
AbobotulinumtoxinA is an effective focal intervention for reducing ULS  and coupled with neurorehabilitation is recommended in standard clinical practice  ; . Treatment with botulinum toxin A (BoNT-A) is generally delayed in post-stroke spasticity until patients show clinical signs of increased muscle tone, usually about 3 months following stroke , despite evidence that symptoms begin much earlier.
Recent studies aimed to evaluate whether earlier post-stroke treatment with BoNT-A may prevent disabling spasticity development ;  ;  and demonstrate that BoNT-A administered within 3 months provides sustained improvement in muscle tone. However, there is a paucity of robust clinical data on spasticity progression timeframes, associated symptom development, functional impairment, and maximal duration of muscle tone reduction with BoNT-A.
The ONTIME pilot study explores these foregoing issues to establish whether treatment with abobotulinumtoxinA (Dysport®) within 2–12 weeks post-stroke might delay symptomatic or disabling spasticity development, and to assess the duration of this effect. Importantly, this study incorporates composite measure of active and passive functionality, involuntary movements and pain.
Continue —> Effect of early use of AbobotulinumtoxinA after stroke on spasticity progression: Protocol for a randomised controlled pilot study in adult subjects with moderate to severe upper limb spasticity (ONTIME pilot)
A new type of relief from pain, stiffness, spasms, and in the upper arm that affect millions of adults affected by spasticity has just been approved by the US Food and Drug Administration (FDA). The agency’s approval of Dysport (abobotulinumtoxinA) opens the door to an injection for the treatment of upper limb spasticity (ULS) in adult patients to decrease the severity of increased muscle tone in elbow flexors, wrist flexors, and finger flexors, according to a media release from the drug’s maker Basking Ridge, NJ-based Ipsen Biopharmaceuticals.
The Ipsen Biopharmaceuticals media release outlines what the company identifies as key benefits associated with Dysport. Among those benefits, the company reports Dysport is the first therapy in the past 5 years approved by the FDA for the treatment of adults with ULS. Furthermore, the company states, the Dysport Phase III trial was the first registration study to evaluate ULS treatment in adult patients with both stroke and traumatic brain injury.
Another benefit reported by the company is statistically significant improvement in muscle tone measured by the Modified Ashworth Scale (MAS) and a significantly higher physician-rated clinical benefit measured by the Physician Global Assessment (PGA) versus placebo at Week 4 (p ≤ 0.05).
According to the media release, clinical improvement may be expected 1 week after administration of Dysport. The company also points out that a majority of patients were retreated between 12 and 16 weeks; however, some patients had duration of response as long as 20 weeks.
The most frequently reported adverse reactions (≥2%) are: urinary tract infection, nasopharyngitis, muscular weakness, musculoskeletal pain, dizziness, fall, and depression, the media release states.
All botulinum toxin products, including Dysport, are said by Ipsen Biopoharmaceuticals to have a Boxed Warning which states that the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism. Those symptoms include swallowing and breathing difficulties that can be life-threatening.
[Source: Ipsen Biopharmaceuticals Inc]
[ARTICLE] Factors Influencing Goal Attainment in Patients with Post-Stroke Upper Limb Spasticity Following Treatment with Botulinum Toxin A in Real-Life Clinical Practice: Sub-Analyses from the Upper Limb International Spasticity (ULIS)-II Study – Full Text HTML
In this post-hoc analysis of the ULIS-II study, we investigated factors influencing person-centred goal setting and achievement following botulinum toxin-A (BoNT-A) treatment in 456 adults with post-stroke upper limb spasticity (ULS). Patients with primary goals categorised as passive function had greater motor impairment (p < 0.001), contractures (soft tissue shortening [STS]) (p = 0.006) and spasticity (p = 0.02) than those setting other goal types. Patients with goals categorised as active function had less motor impairment (0.0001), contracture (p < 0.0001), spasticity (p 1 year)) post-stroke (80.0% vs. 79.2%) or presence or absence of severe contractures (76.7% vs. 80.6%), although goal types differed. Earlier BoNT-A intervention was associated with greater achievement of active function goals. Severe contractures impacted negatively on goal achievement except in pain and passive function. Goal setting by patients with ULS is influenced by impairment severity, age and time since stroke. Our findings resonate with clinical experience and may assist patients and clinicians in selecting realistic, achievable goals for treatment.
Full Text HTML —> Toxins | Free Full-Text | Factors Influencing Goal Attainment in Patients with Post-Stroke Upper Limb Spasticity Following Treatment with Botulinum Toxin A in Real-Life Clinical Practice: Sub-Analyses from the Upper Limb International Spasticity (ULIS)-II Study | HTML.
[Systematic Literature Review]. AbobotulinumtoxinA in Clinical Trials for Adult Upper Limb Spasticity.
…On the basis of data extracted from 12 randomized clinical studies, a strong evidence base (9/12 studies) exists for the use of ABO to reduce ULS caused by stroke…