Archive for July, 2017

[ARTICLE] An Evaluation of the Design and Usability of a Novel Robotic Bilateral Arm Rehabilitation Device for Patients with Stroke – Full Text

Introduction: Robot-assisted therapy for upper limb rehabilitation is an emerging research topic and its design process must integrate engineering, neurological pathophysiology, and clinical needs.

Purpose of the study: This study developed/evaluated the usefulness of a novel rehabilitation device, the MirrorPath, designed for the upper limb rehabilitation of patients with hemiplegic stroke.

Methods: The process follows Tseng’s methodology for innovative product design and development, namely two stages, device development and usability assessment. During the development process, the design was guided by patients’ rehabilitation needs as defined by patients and their therapists. The design applied synchronic movement of the bilateral upper limbs, an approach that is compatible with the bilateral movement therapy and proprioceptive neuromuscular facilitation theories. MirrorPath consists of a robotic device that guides upper limb movement linked to a control module containing software controlling the robotic movement.

Results: Five healthy subjects were recruited in the pretest, and 4 patients, 4 caregivers, and 4 therapists were recruited in the formal test for usability. All recruited subjects were allocated to the test group, completed the evaluation, and their data were all analyzed. The total system usability scale score obtained from the patients, caregivers, and therapists was 71.8 ± 11.9, indicating a high level of usability and product acceptance.

Discussion and conclusion: Following a standard development process, we could yield a design that meets clinical needs. This low-cost device provides a feasible platform for carrying out robot-assisted bilateral movement therapy of patients with hemiplegic stroke.

Clinical Trial Registration: identifier NCT02698605.

Introduction

The World Health Organization (WHO) has reported that stroke is the third leading cause of death in developed countries and involves approximately 15 million stoke events annually. One-third of stroke patients die and a further one-third of events results in permanent disability. Depending on the location of the brain insult, stroke can lead to a wide range of functional impairments (Mackay et al., 2004); these include language, cognition, sensation, and motor functions. Motor impairment impacts the patient’s ability to perform activities of daily living. For the majority of patients, recovery of motor function involving an upper limb is slower than that of lower limb (Feys et al., 1998). Indeed, most activities of daily living rely the functioning of the upper limb, thus emphasizing the need for effective upper limb rehabilitation.

With an attempt to enhance the effectiveness of upper limb rehabilitation among stroke patients, a series of rehabilitation techniques have been developed and refined in recent decades; these include task-oriented motor training, constraint-induced movement therapy, mirror therapy, and bilateral movement training. Each of these methods has a number of theoretical advocates and each has been shown to be effective clinically. For instance, bilateral movement therapy, which involves coordinated movement of the bilateral upper limbs, has been shown to enhance upper limb recovery and coordination between the hands. Stoykov et al. (2009) found that bilateral arm training is more effective than unilateral training when restoring proximal upper limb function because it seems to improve the functional linkages between the bilateral hemispheres.

Even after receiving a full course of conventional rehabilitation, 60% of stroke patients still have difficulties when using their affected upper limb (Kwakkel et al., 1999). As a result, it has become the upmost importance to develop novel rehabilitation strategies that are able to help patients reach a higher level of recovery. One such approach is robot-assisted rehabilitation, which incorporates robotic technologies into the rehabilitation processes. Several well-known robot-assisted movement therapies for the upper limb has been implemented clinically, including MIT-Manus (Krebs et al., 1998), Bi-Manu-Track (Hesse et al., 2003), BATRAC (Cauraugh et al., 2010), and MIME (Burgar et al., 2000), each of which follows different movement therapy theories. Regarding the body parts that are mainly involved in therapy, Bi-Manu-Track focuses on the bilateral forearms and wrists, while BATRAC and MIME focus on the shoulder and elbow of the affected limb. Regarding the movement dimension, BATRAC involves movement in one-dimension, while MIME allows three-dimensional movement. In fact, the higher the degrees of freedom adopted during the movement therapy, the more complex is the design of the robotic device. As a result, it has become important to come up with a feasible design that fulfills the patient’s rehabilitation needs while avoiding the high costs that can be associated with instrument acquirement and maintenance. Furthermore, the effectiveness of the system needs to be comparable to that provided by conventional therapies so that a motivation to pursue this therapeutic option can be established (Kwakkel et al., 2008; Lo et al., 2010).

As an approach to the development of mechanical rehabilitation devices for hemiplegic upper limbs, Timmermans et al. (2009) proposed that three design domains are required; these were the therapy techniques used, the motivation of the patient, and resulting performance rewards. An online survey of physical therapists, 233 in total, indicated that a preferred upper limb robotic device needs to accommodate different hand movements, to be able to be used while in a seated position, to be able to provide the user with feedback, to focus on the restoration of activities of daily living, to able to be used at home, to have adjustable resistance levels and to cost less than US$6,000 (Lu et al., 2011).

In terms of usability, the interaction between the user and the machine tends to be overlooked during the development stage. Although a variety of upper limb rehabilitation machines have been proposed, only a few have been commercialized. This low market acceptance can be attributed to the high cost of these devices, safety concerns, and poor usability (Lee et al., 2005). To this end, the aim of this study was to design a bilateral upper limb rehabilitation device called MirrorPath for the rehabilitation of stroke patients that follows the theories of bilateral movement therapy and proprioceptive neuromuscular facilitation (PNF). These two theories were initially developed by Knott and Kabat and have been shown to have a positive effect on the range of active and passive motions needed by stroke patients (Sharman et al., 2006). Our device will guide the patient’s upper limbs, each of which moves along a diagonal motion path on the horizontal plane. The position and velocity of motion of the bilateral limbs are perfectly mirrored across the midline on the table. Finally, usability testing was conducted on the completed prototype.

Continue —>  Frontiers | An Evaluation of the Design and Usability of a Novel Robotic Bilateral Arm Rehabilitation Device for Patients with Stroke | Frontiers in Neurorobotics

Figure 2. (A) A patient performed bilateral diagonal movements using the device; (B) due to weakness of right upper limb, the patient’s grip was assisted with an elastic bandage, and the patient’s elbow was support by a sling; (C) the application scenario.

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[Abstract+References] Toward wearable supernumerary robotic fingers to compensate missing grasping abilities in hemiparetic upper limb 

This paper presents the design, analysis, fabrication, experimental characterization, and evaluation of two prototypes of robotic extra fingers that can be used as grasp compensatory devices for a hemiparetic upper limb. The devices are the results of experimental sessions with chronic stroke patients and consultations with clinical experts. Both devices share a common principle of work, which consists in opposing the device to the paretic hand or wrist so to restrain the motion of an object. They can be used by chronic stroke patients to compensate for grasping in several activities of daily living (ADLs) with a particular focus on bimanual tasks. The robotic extra fingers are designed to be extremely portable and wearable. They can be wrapped as bracelets when not being used, to further reduce the encumbrance. Both devices are intrinsically compliant and driven by a single actuator through a tendon system. The motion of the robotic devices can be controlled using an electromyography-based interface embedded in a cap. The interface allows the user to control the device motion by contracting the frontalis muscle. The performance characteristics of the devices have been measured experimentally and the shape adaptability has been confirmed by grasping various objects with different shapes. We tested the devices through qualitative experiments based on ADLs involving five chronic stroke patients. The prototypes successfully enabled the patients to complete various bimanual tasks. Results show that the proposed robotic devices improve the autonomy of patients in ADLs and allow them to complete tasks that were previously impossible to perform.

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Source: Toward wearable supernumerary robotic fingers to compensate missing grasping abilities in hemiparetic upper limbThe International Journal of Robotics Research – Irfan Hussain, Giovanni Spagnoletti, Gionata Salvietti, Domenico Prattichizzo, 2017

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[Review] The Neuroscience of Body Memory: from the Self through the Space to the Others – Full Text

Abstract

Our experience of the body is not direct; rather, it is mediated by perceptual information, influenced by internal information, and recalibrated through stored implicit and explicit body representation (body memory). This paper presents an overview of the current investigations related to body memory by bringing together recent studies from neuropsychology, neuroscience, and evolutionary and cognitive psychology. To do so, in the paper, we explore the origin of representations of human body to elucidate their developmental process and, in particular, their relationship with more explicit concepts of self. First, it is suggested that our bodily experience is constructed from early development through the continuous integration of sensory and cultural data from six different representations of the body, i.e., the Sentient Body (Minimal Selfhood), the Spatial Body (Self Location), the Active Body (Agency), the Personal Body (Whole Body Ownership – Me); the Objectified Body (Objectified Self – Mine), and the Social Body (Body Satisfaction – Ideal Me). Then, it is suggested that these six representations can be combined in a coherent supramodal representation, i.e. the “body matrix”, through a predictive, multisensory processing activated by central, top–down, attentional processes. From an evolutionary perspective, the main goal of the body matrix is to allow the self to protect and extend its boundaries at both the homeostatic and psychological levels. From one perspective, the self extends its boundaries (peripersonal space) through the enactment and recognition of motor schemas. From another perspective, the body matrix, by defining the boundaries of the body, also defines where the self is present, i.e., in the body that is processed by the body matrix as the most likely to be its one and in the space surrounding it. In the paper we also introduced and discusses the concept of “embodied medicine”: the use of advanced technology for altering the body matrix with the goal of improving our health and well-being.


1. Introduction

The body is an object of perception, just like any other object in the world. Yet, at the same time, the body is different (Aspell, Lenggenhager, & Blanke, 2012). From one perspective, it provides the background conditions that enable perception and action (cognitive approach); from another perspective, it is associated closely with our sense of self and its intentionality (volitional approach).

For these reasons, different researchers have identified the experience of the body as the possible starting point for the development of a comprehensive scientific model of self-consciousness (Ananthaswamy, 2015; Craig, 2009, 2010; Damasio, 2010; Lenggenhager, Tadi, Metzinger, & Blanke, 2007; Tsakiris, 2012, 2017).

However, to study the experience of the body is not an easy task. As noted by Olaf Blanke (2012), the body is the most multi-sensory “object” in the world; it requires the processing and integration of different bodily signals in the premotor, temporoparietal, posterior parietal, and extrastriate cortices. In addition, our experience of the body is not direct (Figure 1), but it is (Blanke, Slater, & Serino, 2015; Pazzaglia & Zantedeschi, 2016; Riva, […]

 

Continue —>  The Neuroscience of Body Memory: from the Self through the Space to the Others

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[BLOG POST] VAST.Rehab – virtual reality rehabilitation with biofeedback

Why VAST.Rehab?

VAST.Rehab is a fully-featured virtual reality rehabilitation system with the flexibility to work for everyone from small physiotherapy practices to the largest hospitals in the world. VAST.Rehab is easy to learn and use, making it perfect for therapists looking for convenient way to make their patients more motivated to participate in their rehabilitation process.

VAST.Rehab automatically tracks patient’s progress, so therapists spends less time doing the paperwork and more time treating their patients. With Vast.Rehab, clinicians gain access to a range of valid performance metrics from multiple categories.

Once a patient learns how to use the system while working one to one with his clinician, he can take the therapy home. All data is synchronized with our cloud based server, so the clinician knows whether patients do the exercises as prescribed.

VAST.Rehab is classified as a medical device and it received CE marking conforming with the regulatory system of the EU’s medical device directives.

 

Source: VAST.Rehab – virtual reality rehabilitation with biofeedback

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[Abstract] A survey on sEMG control strategies of wearable hand exoskeleton for rehabilitation

Abstract:

Surface electromyographic (sEMG) signals is one most commonly used control source of exoskeleton for hand rehabilitation. Due to the characteristics of non-invasive, convenient collection and safety, sEMG can conform to the particularity of hemiplegic patients’ physiological state and directly reflect human’s neuromuscular activity. By way of collecting, analyzing and processing, sEMG signals corresponding to identify the target movement model would be translated into robot movement control instructions and input into hand rehabilitation exoskeleton controller. Then patients’ hand can be directed to achieve the realization of the similar action finally. In this paper, the recent key technologies of sEMG-based control for hand rehabilitation robots are reviewed. Then a summarization of controlling technology principle and methods of sEMG signal processing employed by the hand rehabilitation exoskeletons is presented. Finally suitable processing methods of multi-channel sEMG signals for the controlling of hand rehabilitation exoskeleton are put forward tentatively and the practical application in hand exoskeleton control is commented also.

Source: A survey on sEMG control strategies of wearable hand exoskeleton for rehabilitation – IEEE Xplore Document

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[Abstract] Determining the potential benefits of yoga in chronic stroke care: a systematic review and meta-analysis

Abstract

Background: Survivors of stroke have long-term physical and psychological consequences that impact their quality of life. Few interventions are available in the community to address these problems. Yoga, a type of mindfulness-based intervention, is shown to be effective in people with other chronic illnesses and may have the potential to address many of the problems reported by survivors of stroke.

Objectives: To date only narrative reviews have been published. We sought to perform, the first systematic review with meta-analyses of randomized controlled trials (RCTs) that investigated yoga for its potential benefit for chronic survivors of stroke.

Methods: Ovid Medline, CINHAL plus, AMED, PubMed, PsychINFO, PeDro, Cochrane database, Sport Discuss, and Google Scholar were searched for papers published between January 1950 and August 2016. Reference lists of included papers, review articles and OpenGrey for Grey literature were also searched. We used a modified Cochrane tool to evaluate risk of bias. The methodological quality of RCTs was assessed using the GRADE approach, results were collated, and random effects meta-analyses performed where appropriate.

Results: The search yielded five eligible papers from four RCTs with small sample sizes (n = 17–47). Quality of RCTs was rated as low to moderate. Yoga is beneficial in reducing state anxiety symptoms and depression in the intervention group compared to the control group (mean differences for state anxiety 6.05, 95% CI:−0.02 to 12.12; p = 0.05 and standardized mean differences for depression: 0.50, 95% CI:−0.01 to 1.02; p = 0.05). Consistent but nonsignificant improvements were demonstrated for balance, trait anxiety, and overall quality of life.

Conclusions: Yoga may be effective for ameliorating some of the long-term consequences of stroke. Large well-designed RCTs are needed to confirm these findings.

Source: Determining the potential benefits of yoga in chronic stroke care: a systematic review and meta-analysis: Topics in Stroke Rehabilitation: Vol 24, No 4

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[Abstract] Is Pilates an effective rehabilitation tool? A systematic review 

Abstract

Background

Pilates is a system of exercise focusing upon controlled movement, stretching and breathing. Pilates is popular today not only for physical fitness but also for rehabilitation programs. This paper is a review of the literature on the effectiveness of Pilates as a rehabilitation tool in a wide range of conditions in an adult population.

Methods

A systematic literature review was carried out according to the PRISMA guidelines. Electronic databases were searched for cohort studies or randomised controlled trials (RCTs), and inclusion and exclusion criteria were applied. The final RCTs were assessed using the PEDro and CONSORT 2010 checklists.

Results

Twenty-three studies, published between 2005 and 2016, met the inclusion criteria. These papers assessed the efficacy of Pilates in the rehabilitation of low back pain, ankylosing spondylitis, multiple sclerosis, post-menopausal osteoporosis, non-structural scoliosis, hypertension and chronic neck pain. Nineteen papers found Pilates to be more effective than the control or comparator group at improving outcomes including pain and disability levels. When assessed using the CONSORT and PEDro scales, the quality of the papers varied, with more falling toward the upper end of the scale.

Conclusion

The majority of the clinical trials in the last five years into the use of Pilates as a rehabilitation tool have found it to be effective in achieving desired outcomes, particularly in the area of reducing pain and disability. It indicates the need for further research in these many areas, and especially into the benefits of particular Pilates exercises in the rehabilitation of specific conditions.

Source: Is Pilates an effective rehabilitation tool? A systematic review – Journal of Bodywork and Movement Therapies

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[BLOG POST] Tyromotion Introduces Virtual Reality to Robotic Therapy to Facilitate Stroke Recovery

Rehabilitation technology leader Tyromotion has developed a rehabilitation device that combines virtual reality with robotic therapy to make stroke rehabilitation faster and more efficient.

Tyromotion has created a rehabilitation device that uses a bilateral 3D arm robot and virtual reality glasses to fully immerse stroke patients in virtual worlds where both the visual and physical environments can be shaped. The device is designed to help patients with limited arm function perform daily tasks by challenging and encouraging them to increase their range of motion and the number of repetitions during their therapy sessions. Both these elements are vital to motor learning.

The introduction of virtual reality into therapy delivers a 3D training environment that can be adapted to each individual patient’s abilities. The virtual setting has a gaming element to it, which helps motivate patients to keep repeating their exercises.

Tyromotion’s device is currently being tested by leading rehabilitation facilities in Europe and the United States. The initial reports from therapists and doctors have been very positive, indicating that the new approach to therapy has a strong potential to transform it by increasing patient motivation and making therapy programs more cost effective across the board.

Diego, the robot-assisted arm rehabilitation device used to deliver VR therapy, is the world’s most versatile arm-shoulder rehabilitation device, one that combines robotics with intelligent gravity compensation (IGC) and virtual reality to help patients regain lost arm function. The device offers passive, active and assistive, uni- and bilateral applications that are easily adapted to meet the needs of each patient.

The gravity compensation feature makes heavy arms lighter, allowing physiological movement of the arms in every phase of rehabilitation. The device gives patients more room and more freedom to move and is particularly well suited for task-oriented training with real objects.

Diego offers a versatile range of therapy options with interactive therapy modules that provide haptic and audiovisual feedback, immersing patients in motion in the virtual environment. The therapy modules have different levels of difficulty, which motivates patients to keep making progress. Their progress is then recorded to make their achievements visible.

Diego is suitable for patients of all ages and can be used in all phases of arm rehabilitation. Watch the video below to learn more about its features and benefits.

Related news:

Tyrostation Offers Versatile Range of Therapy Options

Source: Tyromotion Introduces Virtual Reality to Robotic Therapy to Facilitate Stroke Recovery | Fitness Gaming

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[ARTICLE] AExaCTT – Aerobic Exercise and Consecutive Task-specific Training for the upper limb after stroke: Protocol for a randomised controlled pilot study – Full Text

Abstract

Motor function may be enhanced if aerobic exercise is paired with motor training. One potential mechanism is that aerobic exercise increases levels of brain-derived neurotrophic factor (BDNF), which is important in neuroplasticity and involved in motor learning and motor memory consolidation. This study will examine the feasibility of a parallel-group assessor-blinded randomised controlled trial investigating whether task-specific training preceded by aerobic exercise improves upper limb function more than task-specific training alone, and determine the effect size of changes in primary outcome measures. People with upper limb motor dysfunction after stroke will be allocated to either task-specific training or aerobic exercise and consecutive task-specific training. Both groups will perform 60 hours of task-specific training over 10 weeks, comprised of 3 × 1 hour sessions per week with a therapist and 3 × 1 hours of home-based self-practice per week. The combined intervention group will also perform 30 minutes of aerobic exercise (70–85%HRmax) immediately prior to the 1 hour of task-specific training with the therapist. Recruitment, adherence, retention, participant acceptability, and adverse events will be recorded. Clinical outcome measures will be performed pre-randomisation at baseline, at completion of the training program, and at 1 and 6 months follow-up. Primary clinical outcome measures will be the Action Research Arm Test (ARAT) and the Wolf Motor Function Test (WMFT). If aerobic exercise prior to task-specific training is acceptable, and a future phase 3 randomised controlled trial seems feasible, it should be pursued to determine the efficacy of this combined intervention for people after stroke.

1. Introduction

1.1. Background

Currently 440,000 persons after stroke live in community settings in Australia [1]. Many with stroke experience chronic disability and although two-thirds receive care each day [1], the majority still have unmet needs [2]. Upper limb dysfunction is a persistent and disabling problem present in 69% of persons after stroke in Australia [3]. Upper limb dysfunction is a major contributor to poor well-being and quality-of-life [4]; [5]; [6] ;  [7]. Unsurprisingly, advancing treatments for upper limb recovery is a top ten research priority for persons after stroke and their carers [8].

In Australia, 87% of persons with stroke-attributable upper limb impairments receive task-specific training [3]. Task-specific training is a progressive training strategy that utilises practice of goal-directed, real-world, context-specific tasks that are intrinsically and/or extrinsically meaningful to the person, to enable them to undertake activities of daily living [9] and may improve upper limb motor function after stroke [9]; [10] ;  [11].

Improvements in motor function coincide with structural and functional reorganisation of the brain [12]; [13]; [14] ;  [15]. The brain’s ability to undergo these changes is denoted as neuroplasticity. Capitalisation and enhancement of neuroplasticity in peri-infarct and non-primary motor regions may promote recovery via an increased response to motor training and other neurorehabilitative interventions [16]; [17] ;  [18].

Many studies show that aerobic exercise (prolonged, rhythmical activity using large muscle groups to increase heart rate) enhances neuroplasticity [19], grey matter volume, white matter integrity [20]; [21] ;  [22] and brain activation [23]; [24] ;  [25]. Furthermore increasing evidence indicates that lower limb aerobic exercise increases upper limb motor function. A single bout of aerobic cycling exercise can improve long-term retention of a motor skill in healthy individuals [26], regardless of whether performed immediately before or after motor training [27].

Aerobic exercise increases BDNF [28]. Improvements in motor skill learning and memory induced by aerobic exercise have been associated with increased peripheral blood concentrations of BDNF [26]. BDNF is involved with neurogenesis [29] and neuroprotection [30] in the human brain [31], thereby playing an important role in stroke recovery, including facilitating functional upper limb motor rehabilitation [32].

In chronic stroke, an 8-week programme of lower extremity endurance cycling enhanced upper extremity fine motor control [33]. Also, a single bout of aerobic treadmill exercise improved grasp function of the hemiparetic hand [34]. As aerobic exercise alone can enhance motor function after stroke, motor learning in stroke rehabilitation may be facilitated if aerobic exercise is paired with motor training [35] ;  [36].

1.2. Aims and objectives

The aims of this study are to 1) assess the feasibility of conducting a randomised controlled trial to compare the effects of task-specific training preceded by aerobic exercise to task-specific training alone on upper limb motor function after stroke; and 2) calculate the effect size of changes in primary clinical outcome measures to evaluate proof-of-concept and inform calculation of sample size for a future phase III trial. This includes investigating potential neural correlates of exercise-induced motor function changes using peripheral blood serum BDNF measurement and multi-modal MRI.

2. Methods

2.1. Study design

This is a parallel-group assessor-blinded randomised controlled pilot study (Fig. 1). One group will undertake task-specific training alone and the other group will undertake 30 minutes of aerobic cycling exercise prior to their task-specific training. The interventions will be delivered by a therapist 3 days per week for 10 weeks. Both groups will be provided with an individually-prescribed task-specific training programme to practice at home for 60 minutes, 3 times per week. Assessments will be conducted at baseline, within 1 week from the end of intervention, and 1 and 6 months following the end of the intervention period. Ethics approval has been obtained from the Hunter New England Human Research Ethics Committee (14/12/10/4.07) and registered with the University of Newcastle Human Research Ethics Committee (H-2015-0105). The study is registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12616000848404).

Continue —>  AExaCTT – Aerobic Exercise and Consecutive Task-specific Training for the upper limb after stroke: Protocol for a randomised controlled pilot study

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[ARTICLE] Dose-Dependent Effects of Abobotulinumtoxina (Dysport) on Spasticity and Active Movements in Adults With Upper Limb Spasticity: Secondary Analysis of a Phase 3 Study – Full Text

Abstract

Background

AbobotulinumtoxinA has beneficial effects on spasticity and active movements in hemiparetic adults with upper limb spasticity (ULS). However, evidence-based information on optimal dosing for clinical use is limited.

Objective

To describe joint-specific dose effects of abobotulinumtoxinA in adults with ULS.

Design

Secondary analysis of a phase 3 study (NCT01313299).

Setting

Multicenter, international, double-blind, placebo-controlled clinical trial.

Participants

A total of 243 adults with ULS >6 months after stroke or traumatic brain injury, aged 52.8 (13.5) years and 64.3% male, randomized 1:1:1 to receive a single-injection cycle of placebo or abobotulinumtoxinA 500 U or 1000 U (total dose).

Methods

The overall effect of injected doses were assessed in the primary analysis, which showed improvement of angles of catch in finger, wrist, and elbow flexors and of active range of motion against these muscle groups. This secondary analysis was performed at each of the possible doses received by finger, wrist, and elbow flexors to establish possible dose effects.

Main Outcome Measures

Angle of arrest (XV1) and angle of catch (XV3) were assessed with the Tardieu scale, and active range of motion (XA).

Results

At each muscle group level (finger, wrist, and elbow flexors) improvements in all outcome measures assessed (XV1, XV3, XA) were observed. In each muscle group, increases in abobotulinumtoxinA dose were associated with greater improvements in XV3 and XA, suggesting a dose-dependent effect.

Conclusions

Previous clinical trials have established the clinical efficacy of abobotulinumtoxinA by total dose only. The wide range of abobotulinumtoxinA doses per muscle groups used in this study allowed observation of dose-dependent improvements in spasticity and active movement. This information provides a basis for future abobotulinumtoxinA dosing recommendations for health care professionals based on treatment objectives and quantitative assessment of spasticity and active range of motion at individual joints.

Introduction

Upper limb spasticity (ULS) is a common symptom after stroke and traumatic brain injury (TBI) and is associated with impaired self-care and additional burden of care [1-5]. Among several treatment strategies, guidelines recommend intramuscular botulinum toxin injections as a first-line treatment for adults with ULS [6-11].

Botulinum toxin type A (BoNT-A) injections may target upper extremity muscle groups from the shoulder, to decrease adductor and internal rotation tone, to the elbow, wrist, fingers, and thumb, to decrease flexor tone [12,13]. Specific muscle selection is based on the pattern of muscle overactivity, functional deficits, and patient goals [6]. These goals include increased passive and active range of motion, improved function (feeding and dressing), easier care (palmar and axillary hygiene), and reduction of pain [13].

Evidence-based information on optimal dosing for clinical use is relatively sparse. Dosing is not interchangeable between different BoNT-A products; therefore, improving our understanding of product-specific dosing will minimize confusion among injectors and improve the quality of patient care [13].

Among BoNT-A formulations, abobotulinumtoxinA (Dysport; Galderma Laboratories, LP, Fort Worth, TX) has been shown to decrease muscle tone (as measured by the Modified Ashworth Scale [MAS]) [13-17] and pain [18] and to facilitate goal attainment [19] in adults with ULS. A recent systematic review [13] of 12 randomized controlled trials (RCTs) in ULS concluded that abobotulinumtoxinA (total dose range, 500-1500 U) was generally well-tolerated, with “strong evidence” to support reduced muscle tone.

This paper presents the results of a secondary analysis from a recently published large international clinical trial, demonstrating improved active range of motion after abobotulinumtoxinA treatment in adults with hemiparesis and ULS >6 months after stroke or TBI [20]. This phase 3, randomized, double-blind, placebo-controlled study demonstrated that a total dose of either 500 U or 1000 U abobotulinumtoxinA injected in the upper extremity also resulted in decreased muscle tone and improvements in global physician-assessed clinical benefit compared with placebo.

Apart from a systematic measurement of active range of motion (XA) against finger, wrist, and elbow flexors, another unique aspect of the trial was the assessment of spasticity at the finger, wrist, and elbow flexor groups with the Tardieu scale (TS) [21,22]. The TS is a standardized evaluation used to assess the angle of arrest at slow speed (ie, passive range of motion, XV1) and the angle of catch at fast speed (XV3). The trial demonstrated improvements for finger, wrist, and elbow joints at week 4 in XV3 at both abobotulinumtoxinA doses and in XA at 1000 U; for the 500-U dose, improvements in XA were seen in the finger flexors. Both doses were associated with a favorable safety profile [20]. This analysis aims to provide a detailed description of improvements in spasticity and the active range of motion for individual muscle groups by dose and to provide information on muscle-specific dosing, which can be used in future recommendations for injectors.

Continue —> Dose-Dependent Effects of Abobotulinumtoxina (Dysport) on Spasticity and Active Movements in Adults With Upper Limb Spasticity: Secondary Analysis of a Phase 3 Study – ScienceDirect

 

Figure 1. Change from baseline of Tardieu scale parameters and of active range of motion week 4 postinjection in (A) extrinsic finger flexors, (B) wrist flexors, and (C) elbow flexors. Dose groups were as follows (lowest to highest dose): 500 U/non-PTMG, 500 U/PTMG, 1000 U/non-PTMG, and 1000 U/PTMG. Standard deviations and mean change from baseline values are detailed in Table 3. PTMG = primary targeted muscle group; XV1 = passive range of motion; XV3 = angle of catch at fast speed; XA = active range of motion.

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