Posts Tagged Spasticity

[Abstract] Effects of a 3D-printed orthosis compared to a low-temperature thermoplastic plate orthosis on wrist flexor spasticity in chronic hemiparetic stroke patients: a randomized controlled trial

The aim of this study was to compare the effects of two kinds of wrist-hand orthosis on wrist flexor spasticity in chronic stroke patients.

This is a randomized controlled trial.

The study was conducted in a rehabilitation center.

A total of 40 chronic hemiparetic stroke patients with wrist flexor spasticity were involved in the study.

Patients were randomly assigned to either an experimental group (conventional rehabilitation therapy + 3D-printed orthosis, 20 patients) or a control group (conventional rehabilitation therapy + low-temperature thermoplastic plate orthosis, 20 patients). The time of wearing orthosis was about 4–8 hours per day for six weeks.

Primary outcome measure: Modified Ashworth Scale was assessed three times (at baseline, three weeks, and six weeks). Secondary outcome measures: passive range of motion, Fugl-Meyer Assessment score, visual analogue scale score, and the swelling score were assessed twice (at baseline and six weeks). The subjective feeling score was assessed at six weeks.

No significant difference was found between the two groups in the change of Modified Ashworth Scale scores at three weeks (15% versus 25%, P = 0.496). At six weeks, the Modified Ashworth Scale scores (65% versus 30%, P = 0.02), passive range of wrist extension (P < 0.001), ulnar deviation (P = 0.028), Fugl-Meyer Assessment scores (P < 0.001), and swelling scores (P < 0.001) showed significant changes between the experimental group and the control group. No significant difference was found between the two groups in the change of visual analogue scale scores (P = 0.637) and the subjective feeling scores (P = 0.243).

3D-printed orthosis showed greater changes than low-temperature thermoplastic plate orthosis in reducing spasticity and swelling, improving motor function of the wrist and passive range of wrist extension for stroke patients.

via Effects of a 3D-printed orthosis compared to a low-temperature thermoplastic plate orthosis on wrist flexor spasticity in chronic hemiparetic stroke patients: a randomized controlled trial – Yanan Zheng, Gongliang Liu, Long Yu, Yanmin Wang, Yuan Fang, Yikang Shen, Xiuling Huang, Lei Qiao, Jianzhong Yang, Ying Zhang, Zikai Hua,

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[Abstract] Ergometer training in stroke rehabilitation: systematic review and meta-analysis

Abstract

Objective

Ergometer training is routinely used in stroke rehabilitation. How robust is the evidence of its effects?

Data source

The PubMed database and PEDro database were reviewed prior to 22/01/2019.

Study selection

Randomized controlled trials investigating the effects of ergometer training on stroke recovery were selected.

Data extraction

Two reviewers independently selected the studies, performed independent data extraction, and assessed the risk of bias.

Data synthesis

A total of 28 studies (including 1115 stroke subjects) were included. The data indicates that

(1) ergometer training leads to a significant improvement of walking ability, cardiorespiratory fitness, motor function and muscular force of lower limbs, balance and postural control, spasticity, cognitive abilities, as well as the brain’s resistance to damage and degeneration,

(2) neuromuscular functional electrical stimulation assisted ergometer training is more efficient than ergometer training alone,

(3) high-intensity ergometer training is more efficient that low-intensity ergometer training, and

(4) ergometer training is more efficient than other therapies in supporting cardiorespiratory fitness, independence in activities of daily living, and balance and postural control, but less efficient in improving walking ability.

Conclusion

Ergometer training can support motor recovery after stroke. However, current data is insufficient for evidence-based rehabilitation. More data is required about the effects of ergometer training on cognitive abilities, emotional status, and quality of life in stroke subjects.

via Ergometer training in stroke rehabilitation: systematic review and meta-analysis – Archives of Physical Medicine and Rehabilitation

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[Abstract] Design of Powered Wearable Elbow Brace for Rehabilitation Applications at Clinic and Home – IEEE Conference Publication

Abstract

Spasticity and contractures are secondary to most neurological and orthopaedic pathologies. The most conservative method of management of spasticity and contractures is passive stretching exercises. Robotic rehabilitation aims to provide a solution to this problem. We describe in details the design of a powered wearable orthosis especially designed for managing spasticity and contractures. The device is fully portable, allowing the patient to undergo repeated-passive-dynamic exercises outside the hospital environment. The design of the device is modular to make it adaptable to different anatomies and pathologies. The device is also fitted with electrogoniometers and torque sensors to record kinematics and dynamics of the patient, improving the insight of the clinicians to the rehabilitation of the patient, as well as providing data for further clinical and scientific investigations. The mechanical integrity of the device elements is simulated and verified.

via Design of Powered Wearable Elbow Brace for Rehabilitation Applications at Clinic and Home – IEEE Conference Publication

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[ARTICLE] A comparison of the rehabilitation effectiveness of neuromuscular electrical stimulation robotic hand training and pure robotic hand training after stroke: A randomized controlled trial – Full Text

Highlights

The rehabilitation effects of the NMES robotic hand and robotic hand were compared.

Both training systems could significantly improve the motor function of upper limb.

The NMES robot was more effective than the pure robot.

NMES applied on distal muscle could benefit the recovery in the entire upper limb.

 

Abstract

Objective

To compare the rehabilitation effects of the electromyography (EMG)-driven neuromuscular electrical stimulation (NMES) robotic hand and EMG-driven robotic hand for chronic stroke.

Methods

This study was a randomized controlled trial with a 3-month follow-up. Thirty chronic stroke patients were randomly assigned to receive 20-session upper limb training with either EMG-driven NMES robotic hand (NMES group, n = 15) or EMG-driven robotic hand (pure group, n = 15). The training effects were evaluated before and after the training, as well as 3 months later, using the clinical scores of Fugl-Meyer Assessment (FMA), Modified Ashworth Scale (MAS), Action Research Arm Test (ARAT), and Functional Independence Measure (FIM). Session-by-session EMG parameters, including the normalized EMG activation level and co-contraction indexes (CIs) of the target muscles were applied to monitor the recovery progress in muscular coordination patterns.

Results

Both groups achieved significantly increased FMA and ARAT scores (p < 0.05), and the NMES group improved more (p < 0.05). A significant improvement in MAS was obtained in the NMES group (p < 0.05) but absence in the pure group. Meanwhile, better performance could be obtained in the NMES group in releasing the EMG activation levels and CIs than the pure group across the training sessions (p < 0.05).

Conclusion

Both training systems were effective in improving the long-term distal motor functions in upper limb, where the NMES robot-assisted training achieved better voluntary motor recovery and muscle coordination and more release in muscle spasticity.

Significance

This study indicated more effective distal rehabilitation using the NMES robot than the pure robot-assisted rehabilitation.

1. Introduction

Upper limb motor deficits are common after stroke, and observed in over 80% of stroke survivors [1,2]. Various rehabilitation devices have been purposed to assist human physical therapists to provide effective long-term rehabilitation programs [[3][4][5]]. Among them, rehabilitation robots and neuromuscular electrical stimulation (NMES) are most widely used in stroke rehabilitation practices. Rehabilitation robots have been recognized as efficient in such cases and could represent a cost-effective addition to conventional rehabilitation services because they provide highly intensive and repetitive training [[6][7][8][9]]. It has been reported that the integration of voluntary effort (e.g. electromyography, EMG) into robotic design could contribute significantly to motor recovery in stroke patients [6,10]. This is because an EMG-driven strategy can maximize the involvement of voluntary effort in the training, and its effectiveness at improving upper limb voluntary motor functions have been proved by many EMG-driven robot-assisted upper-limb training systems [[11][12][13]]. However, rehabilitation robots are unable to directly activate the desired muscle groups, which may only assist, or even dominate limb movement such as continuous passive motions (CPM) [14]. In addition, stroke patients usually cooperate with compensatory motions from other muscular activities to activate the target muscles, which may lead to ‘learned disuse’ [15]. However, NMES can effectively limit compensatory motions by stimulating specific muscles via cyclic electrical currents, which provides repetitive sensorimotor experiences [16]. With the advantage of precisely activating the target muscle, NMES has been reported to be effective in evoking sensory feedback, improving muscle force, and thus promoting motor function in stroke patients [17,18]. Nevertheless, training programs assisted by NMES alone are also suboptimal due to the difficulty of controlling movement trajectories and the early appearance of fatigue [19,20].

Accordingly, various NMES robot-assisted upper-limb training programs which combine these two unique techniques have been proposed to integrate the benefits and minimize the disadvantages [7,12,14,21,22]. The rehabilitation effectiveness of these combined systems has been investigated and reported to be effective in improving motor recovery. Several studies have compared the training outcomes of NMES robot-assisted training and other training programs. For example, Qian et al. [22] reported that NMES-robot-assisted upper-limb training could achieve better motor outcomes when compared with conventional therapies for subacute stroke patients. Meanwhile, another study which compared the training effects between robot-aided training with NMES and robot-aided training solely using the InMotion ARM™ Robot in the subacute period demonstrated that the active ranges of motion of the NMES robot-training group were significantly higher compared with the robot-training group [23]. Coincidentally, investigations into applications in chronic stroke patients have also been carried out. For instance, Hu et al. [14] proposed an EMG-driven NMES robot system for wrist training; this combined device improved muscle activation levels related to the wrist and reduced compensatory muscular activities at the elbow, while these training outcomes were absent for the EMG-driven robot-assisted training alone. Indeed, a similar study by another research group also achieved better rehabilitation outcomes on some clinical assessments using the combined system compared to robot-assisted therapy alone [21].

In the literature, most studies on current rehabilitation devices combining the NMES and robotic systems targeted the elbow and wrist joints [7,[21][22][23]], while very few focused on the hand and fingers [24]. In addition, a comparison of the training effects for hand rehabilitation between the NMES robot and other hand rehabilitation devices has not yet been adequately conducted. Indeed, the primary upper-limb disability post-stroke is the loss of hand function, and rehabilitation of the distal joints after stroke is much more difficult than the motor recovery of the proximal joints due to the compensatory motions from the proximal joints [25]. Hence, developing effective rehabilitation devices to minimize compensatory movements for hand motor recovery is especially meaningful for stroke rehabilitation. In our previous work, we developed an EMG-driven NMES robotic hand and suggested it for use in hand rehabilitation after stroke [26]. Our device provides fine control of hand movements and activates the target muscles selectively for finger extension/flexion, and its feasibility and effectiveness have been verified by a single group trial [12]. However, whether the long-term rehabilitation effect of this EMG-driven NMES robotic hand is comparable or even better than other hand rehabilitation devices are still unclear and need to be investigated quantitively. Therefore, the objective of this study is to compare the training effects of hand rehabilitation assisted by an NMES robotic hand and by a pure robotic hand though a randomized controlled trial with a 3-month follow-up (3MFU).

2. Methodology

2.1. Participants

This work was approved by the Human Subjects Ethics Sub-Committee of the Hong Kong Polytechnic University. A total of 53 stroke survivors were screened for the training from local districts. 30 participants with chronic stroke satisfied the following inclusion criteria: (1) The participants were at least 6 months after the onset of a singular and unilateral brain lesion due to stroke, (2) both the metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joints could be extended to 180° passively, (3) muscle spasticity during extension at the finger joints and the wrist joint was below 3 as measured by the Modified Ashworth Scale (MAS) [27], ranged from 0 (no increase in muscle tone) to 4 (affected part rigid), (4) detectable voluntary EMG signals from the driving muscle on the affected side (three times of the standard deviation (SD) above the EMG baseline), and (5) no visual deficit and able to understand and follow simple instructions as assessed by the Mini-Mental State Examination (MMSE > 21) [28].

This work involved a randomized controlled trial with a 3-month follow-up (3MFU). The potential participants were first told that the training program they would receive could be either NMES robotic hand training or pure robotic hand training, and all recruited participants submitted their written consent before randomization. Then, the recruited participants were randomly assigned into two groups according to a computer-based random number generator, i.e., the computer program generated either “1” (denoting the NMES robotic hand training group) or “2” (the pure robotic hand group) with an equal probability of 0.5 (Matlab, 2017, Mathworks, Inc.). Fig. 1 shows the Consolidated Standards of Reporting Trials flowchart of the training program.

Fig. 1

Fig. 1. The consolidated standards of reporting trials flowchart of the experimental design.

2.2. Interventions

For both groups, each participant was invited to attend a 20-session robotic hand training with an intensity of 3–5 sessions/week, completed within 7 consecutive weeks. The training setup of both groups is shown in Fig. 2. This robotic hand training system can assist with finger extension and flexion of the paretic limb for patients after stroke. In this work, real-time voluntary EMG detected from the abductor pollicis brevis (APB) and extensor digitorum (ED) muscles were used to control the respective hand closing and opening movements, and the threshold level of each motion phase was set at three times the SD above the EMG baseline at resting state [12]. For example, during the motions of finger flexion, once the EMG activation level of the APB muscle reached a preset threshold, the robotic hand would provide mechanical assistance for hand closing. Similarly, during the motions of finger extension, the robotic hand would assist with hand opening when the EMG activation level of the ED muscle reached a preset threshold. For the NMES robot group, synchronized support from the NMES and the robot were both provided. The NMES electrode pair (30 mm diameter; Axelgaard Corp., Fallbrook, CA, USA) was attached over the ED muscle to provide stimulation during finger extension. The outputs of NMES were square pulses with a constant amplitude of 70 V, a stimulation frequency of 40 Hz, and a manually adjustable pulse width in the range 0–300 μs. Before the training, the pulse width was set at the minimum intensity, which achieved a fully extended position of the fingers in each patient. During the training, NMES would be triggered by the EMG from the ED muscle first and then provided stimulation to the ED muscle to assist hand-opening motions for the entire phase of finger extension, while no assistance from NMES was provided during finger flexion to avoid the possible increase of finger spasticity after stimulation [29]. For the pure robot group, the difference between the two groups was that no NMES was applied in the pure robot group. A detailed account of the working principles of the robotic hand have been described in our previous work [12,30,31].

Fig. 2

Fig. 2. The experimental setup of the robotic hand training: (A) pure robotic hand group; (B) neuromuscular electrical stimulation (NMES) robotic hand group.

 […]

 

Continue —-> A comparison of the rehabilitation effectiveness of neuromuscular electrical stimulation robotic hand training and pure robotic hand training after stroke: A randomized controlled trial – ScienceDirect

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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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[Abstract] Effect of functional electrical stimulation plus body weight-supported treadmill training for gait rehabilitation in patients with poststroke – a retrospective case-matched study.

Abstract

BACKGROUND:

Functional electrical stimulation (FES) plus body weight-supported treadmill training (BWSTT) provide effective gait training for poststroke patients with abnormal gait. These features promote a successful active motor relearning of ambulation in stroke survivors.

AIM:

This is a retrospective study to assess the effect of FES plus BWSTT for gait rehabilitation in patients poststroke.

DESIGN:

A retrospective case-matched study.

SETTING:

Participants were recruited from a rehabilitation department in an acute university-affiliated hospital.

POPULATION:

Ninety patients poststroke from Yue Bei People’s Hospital underwent BWSTT (A: control group) were compared to an equal number of cross-matched patients who received FES plus BWSTT (B: FES plus BWSTT group).

METHODS:

While B group received FES for 45 minutes plus BSWTT for 30 minutes in the program, group A received time-matched BWSTT alone. The walking speed, step length, step cadence, Fugl-Meyer lower-limb scale (LL-FMA), composite spasticity scale (CSS), 10-Meter Walk Test (10MWT), Tinetti Balance Test (TBT) and nerve physiology testing were collected before and after intervention.

RESULTS:

One hundred and eighty patients with poststroke abnormal gait were chosen. There were significant differences in walking speed, step length, step cadence, LL-FMA, CSS, TBT, and 10MWT between baseline and post-intervention (P<0.05). There were significant differences in walking speed, step length, step cadence, LL-FMA, CSS, TBT, and 10MWT between two groups at the end of the eighth week (P<0.05), but not at baseline (P>0.05). In comparison with group A, the peak of somatosensory evoked potential (SEP) and motor evoked potential (MEP) amplitude increased, the latency was shortened, and the conduction velocity of sensory nerve (SCV) and motor nerve (MCV) was significantly increased in the group B (P < 0.05). No adverse events occurred during the study.

CONCLUSIONS:

This study suggests that FES plus BWSTT could be more effective than BWSTT alone in the improvement of gait, balance, spasticity, and function of the lower limb in patients poststroke.

CLINICAL REHABILITATION IMPACT:

Introduce effective rehabilitation strategies for poststroke patients with abnormal gait.

 

via Effect of functional electrical stimulation plus body weight-supported treadmill training for gait rehabilitation in patients with poststroke-a ret… – PubMed – NCBI

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[BLOG POST] Home After a Stroke: What I Learned About Splints as a Stroke Survivor

What I Learned About Splints as a Stroke Survivor

When spasticity from a stroke holds muscles in one position, muscle fibers become short which restricts motion.  Lannin (1) concluded “splinting has little or no effect on the loss of range of motion” (p. 113).  Unfortunately, Lannin told therapists to stop all passive stretching and restrict active hand exercises to 10 minutes a day.  So the data does not tell us if a resting night splint is a useful addition to standard therapy.

I wondered what would happen if I continued to do passive stretching and active hand exercises, but stopped wearing my resting splint at night.  After a month of not wearing this splint I could feel my thumb getting tighter.  I resumed wearing my splint and the next morning I woke up with a wicked ache in my thumb.  My thumb is tight by bedtime so my splint has not eliminated spasticity.  Placing the hand in one static position does not retrain the brain to produce active range of motion (AROM).  Yet I believe my splint has prevented a painful permanent contracture.

I love my new SaeboStretch resting splint I wear at night.  The new soft straps do not cut into my skin the way the old plastic straps did.  This version also uses a new kind of “Velcro” that does not have spiky hooks that scratch my bare thigh.  Notice that there are now two finger straps and two thumb straps.  The cover zips off so it can be washed.

1.  Lannin N, Cusick A, McCluskey A, Herbert R. Effects of splinting on wrist contracture after stroke. Stroke. 2009;38:111-116.

 

via Home After a Stroke: What I Learned About Splints as a Stroke Survivor

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[WEB PAGE] Dysport is Now Approved for Upper Limb Spasticity as Well

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The United States Food and Drug Administration (FDA) has expanded the use of Dysport (abobotulinumtoxinA) for injection to include the treatment of upper limb spasticity in children two years of age and older, excluding spasticity caused by cerebral palsy (CP), Ipsen Biopharmaceuticals, an affiliate of Ipsen, announces in a news release.

This approval makes Dysport the first botulinum toxin approved by the FDA for both pediatric spasticity indications, following the previous approval to treat children with lower limb spasticity aged two and older received in July 2016.

“For physicians, it is reassuring to have a botulinum toxin treatment in Dysport which demonstrated sustained symptom relief for spasticity, which can be physically challenging for children,” says Ann Tilton, MD, study investigator and Professor of Clinical Neurology at the Louisiana State University Health Sciences Center New Orleans, in the release.

“This FDA decision for Dysport means we now have an approved therapy to offer children and adolescents seeking improvements in mobility in both upper and lower limbs.”

The approval is based on a Phase 3 study with children aged two to 17 years old being treated for upper limb spasticity. Due to Orphan Drug Exclusivity, this approval excludes use in children with upper limb spasticity caused by CP. Dysport demonstrated statistically significant improvements from baseline at Week 6 with doses of 8 Units/kg and 16 Units/kg vs. 2 Units/kg, as measured by the Modified Ashworth Scale (MAS) in the elbow or wrist flexors.

Dysport demonstrated a reduction in spasticity symptoms through 12 weeks for most children for both upper and lower limbs. In the upper limb study, a majority of patients were retreated between 16-28 weeks; however, some patients had a longer duration of response (ie, 34 weeks or more). The most frequent adverse reactions observed were upper respiratory tract infection and pharyngitis, the release explains.

“This approval is a testament to Ipsen’s legacy in neurotoxin research and continued commitment to advancing patient care,” states Kimberly Baldwin, Vice President, Franchise Head, Neuroscience Business Unit, Ipsen. “We believe the data for both pediatric upper and lower limb spasticity underscore the role of Dysport as an important treatment option for patients seeking long-lasting spasticity symptom relief.”

For more information, visit Ipsen.

[Source(s): Ipsen, Business Wire]

 

via Dysport is Now Approved for Upper Limb Spasticity as Well – Rehab Managment

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[Abstract] Effects of kinesio taping on hemiplegic hand in patients with upper limb post-stroke spasticity: a randomized controlled pilot study

Abstract

BACKGROUND: Post-stroke spasticity is a common complication in patients with stroke and a key contributor to impaired hand function after stroke.
AIM: The purpose of this study was to investigate the effects of kinesio taping on managing spasticity of upper extremity and motor performance in patients with subacute stroke.
DESIGN: A randomized controlled pilot study.
SETTING: A hospital center.
POPULATION: Participants with stroke within six months.
METHODS: Thirty-one participants were enrolled. Patients were randomly allocated into kinesio taping (KT) group or control group. In KT group, Kinesio Tape was applied as an add-on treatment over the dorsal side of the affected hand during the intervention. Both groups received regular rehabilitation 5 days a week for 3 weeks. The primary outcome was muscle spasticity measured by modified Ashworth Scale (MAS). Secondary outcomes were functional performances of affected limb measured by using Fugl-Meyer assessment for upper extremity (FMA-UE), Brunnstrom stage, and the Simple Test for Evaluating Hand Function (STEF). Measures were taken before intervention, right after intervention (the third week) and two weeks later (the fifth week).
RESULTS: Within-group comparisons yielded significant differences in FMA-UE and Brunnstrom stages at the third and fifth week in the control group (P=0.003-0.019). In the KT group, significant differences were noted in FMA-UE, Brunnstrom stage, and MAS at the third and fifth week (P=0.001-0.035), and in the proximal part of FMA-UE between the third and fifth week (P=0.005). Between-group comparisons showed a significant difference in the distal part of FMA-UE at the fifth week (P=0.037).
CONCLUSIONS: Kinesio taping could provide some benefits in reducing spasticity and in improving motor performance on the affected hand in patients with subacute stroke.
CLINICAL REHABILITATION IMPACT: Kinesio taping could be a choice for clinical practitioners to use for effectively managing post-stroke spasticity.

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via Effects of kinesio taping on hemiplegic hand in patients with upper limb post-stroke spasticity: a randomized controlled pilot study – European Journal of Physical and Rehabilitation Medicine 2019 October;55(5):551-7 – Minerva Medica – Journals

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[REVIEW] Repetitive transcranial magnetic stimulation in stroke rehabilitation: review of the current evidence and pitfalls – Full Text

Acute brain ischemia causes changes in several neural networks and related cortico-subcortical excitability, both in the affected area and in the apparently spared contralateral hemisphere. The modulation of these processes through modern techniques of noninvasive brain stimulation, namely repetitive transcranial magnetic stimulation (rTMS), has been proposed as a viable intervention that could promote post-stroke clinical recovery and functional independence. This review provides a comprehensive summary of the current evidence from the literature on the efficacy of rTMS applied to different clinical and rehabilitative aspects of stroke patients. A total of 32 meta-analyses published until July 2019 were selected, focusing on the effects on motor function, manual dexterity, walking and balance, spasticity, dysphagia, aphasia, unilateral neglect, depression, and cognitive function after a stroke. Only conventional rTMS protocols were considered in this review, and meta-analyses focusing on theta burst stimulation only were excluded. Overall, both HF-rTMS and LF-rTMS have been shown to be safe and well-tolerated. In addition, the current literature converges on the positive effect of rTMS in the rehabilitation of all clinical manifestations of stroke, except for spasticity and cognitive impairment, where definitive evidence of efficacy cannot be drawn. However, routine use of a specific paradigm of stimulation cannot be recommended yet due to a significant level of heterogeneity of the studies in terms of protocols to be set and outcome measures that have to be used. Future studies need to preliminarily evaluate the most promising protocols before going on to multicenter studies with large cohorts of patients in order to achieve a definitive translation into daily clinical practice.

Background

Stroke is a common acute neurovascular disorder that causes disabling long-term limitations to daily living activities. The most common consequence of a stroke is motor deficit of variable degree,1 although nonmotor symptoms are also relevant and often equally disabling.2 To date, to the best of the authors’ knowledge, there is no validated treatment that is able to restore the impaired functions by a complete recovery of the damaged tissue. Indeed, stroke management basically consists of reducing the initial ischemia in the penumbra, preventing future complications, and promoting a functional recovery using physiotherapy, speech therapy, occupational therapy, and other conventional treatments.3,4

Ischemic damage is associated with significant metabolic and electrophysiological changes in cells and neural networks involved in the affected area. From a pure electrophysiological perspective, however, beyond the affected area, there is a local shift in the balance between the inhibition and excitation of both the affected and contralateral hemisphere, consisting of increased excitability and disinhibition (reduced activity of the inhibitory circuits).3,5 In addition, subcortical areas and spinal regions may be altered.3,5 In particular, the role of the uninjured hemisphere seems to be of utmost significance in post-stroke clinical and functional recovery.

Different theoretical models have been proposed to explain the adaptive response of the brain to acute vascular damage. According to the vicariation model, the activity of the unaffected hemisphere contributes to the functional recovery after a stroke through the replacement of the lost functions of the affected areas. The interhemispheric competition model considers the presence of mutual inhibition between the hemispheres, and the damage caused by a stroke disrupts this balance, thus producing a reduced inhibition of the unaffected hemisphere by the affected side. This results in increased inhibition of the affected hemisphere by the unaffected side. More recently, a new model, called bimodal balance recovery, has been proposed.3,5 It introduces the concept of a structural reserve, which describes the extent to which the nondamaged neural pathways contribute to the clinical recovery. The structural reserve determines the prevalence of the interhemispheric imbalance over vicariation. When the structural reserve is high, the interhemispheric competition model can predict the recovery better than the vicariation model, and vice versa.3

Repetitive transcranial magnetic stimulation

One of the proposed interventions to improve stroke recovery, by the induction of neuromodulation phenomena, is based on methods of noninvasive brain stimulation. Among them, transcranial magnetic stimulation (TMS) is a feasible and painless neurophysiological technique widely used for diagnostic, prognostic, research, and, when applied repetitively, therapeutic purposes.69 By electromagnetic induction, TMS generates sub or suprathreshold currents in the human cortex in vivo and in real time.10,11

The most common stimulation site is the primary motor cortex (M1), that generates motor evoked potentials (MEPs) recorded from the contralateral muscles through surface electromyography electrodes.11 The intensity of TMS, measured as a percentage of the maximal output of the stimulator, is tailored to each patient based on the motor threshold (MT) of excitability. Resting MT (rMT) is found when the target muscle is at rest, it is defined as the minimal intensity of M1 stimulation required to elicit an electromyography response with a peak-to-peak amplitude > 50 µV in at least 5 out of 10 consecutive trials.11 Alternatively TMS MTAT 2.0 software (http://www.clinicalresearcher.org/software.htm) is a free tool for TMS researchers and practitioners. It provides four adaptive methods based on threshold-tracking algorithms with the parameter estimation by sequential testing, using the maximum-likelihood strategy for estimating MTs. Active MT (aMT) is obtained during a tonic contraction of the target muscle at approximately 20% of the maximal muscular strength.11

The rMT is considered a basic parameter in providing the global excitation state of a central core of M1 neurons.11 Accordingly, rMT is increased by drugs blocking the voltage-gated sodium channels, where the same drugs may not have an effect on the gamma-aminobutyric acid (GABA)-ergic functions. In contrast, rMT is reduced by drugs increasing glutamatergic transmission not mediated by the N-methyl-D-aspartate (NMDA) receptors, suggesting that rMT reflects both neuronal membrane excitability and non-NMDA receptor glutamatergic neurotransmission.12 Finally, the MT increases, being often undetectable, when a substantial portion of M1 or the cortico-spinal tract is damaged (i.e. by stroke or motor neuron disease), and decreases when the motor pathway is hyperexcitable (such as epilepsy).13

Repetitive (rTMS) is a specific stimulation paradigm characterized by the administration of a sequence of consecutive stimuli on the same cortical region, at different frequencies and inter sequence intervals. As known, rTMS can transiently modulate the excitability of the stimulated cortex, with both local and remote effects outlasting the stimulation period. Conventional rTMS modalities include high-frequency (HF-rTMS) stimulation (>1 Hz) and low-frequency (LF-rTMS) stimulation (⩽1 Hz).11 High-frequency stimulation typically increases motor cortex excitability of the stimulated area, whereas low-frequency stimulation usually produces a decrease in excitability.14 The mechanisms by which rTMS modulates the brain are rather complex, although they seem to be related to the phenomena of long-term potentiation (LTP) and long-term depression (LTD).15

When applied after a stroke, rTMS should ideally be able to suppress the so called ‘maladaptive plasticity’16,17 or to enhance the adaptive plasticity during rehabilitation. These goals can be achieved by modulating the local cortical excitability or modifying connectivity within the neuronal networks.10

rTMS in stroke rehabilitation: an overview

According to the latest International Federation of Clinical Neurophysiology (IFCN) guidelines on the therapeutic use of rTMS,10 there is a possible effect of LF-rTMS of the contralesional motor cortex in post-acute motor stroke, and a probable effect in chronic motor stroke. An effect of HF-rTMS on the ipsilesional motor cortex in post-acute and chronic motor stroke is also possible.

The potential role of rTMS in gross motor function recovery after a stroke has been assessed in a recent comprehensive systematic review of 70 studies by Dionisio and colleagues.18 The majority of the publications reviewed report a role of rTMS in improving motor function, although some randomized controlled trials (RCTs) were not able to confirm this result,1923 as shown by a recent large randomized, sham-controlled, clinical trial of navigated LF-rTMS.24 It has also been suggested that rTMS can specifically improve manual dexterity,10 which is defined as the ability to coordinate the fingers and efficiently manipulate objects, and is of crucial importance for daily living activities.25 Notably, most of the studies focused on motor impairment in the upper limbs, whereas limited data is available on the lower limbs.18 Walking and balance are frequently impaired in stroke patients and significantly affect the quality of life (QoL),26,27 and rTMS might represent a valid aid in the recovery of these functions.28,29 Spasticity is another common complication after a stroke, consisting of a velocity-dependent increase of muscular tone,30 and for which rTMS has been proposed as a rehabilitation tool.31

Dysphagia is highly common in stroke patients, it impairs the global clinical recovery, and predisposes to complications.32 It has been pointed out that rTMS targeting the M1 area representing the muscles involved in swallowing may contribute to the treatment of post-stroke dysphagia.33

Nonmotor deficit is also a relevant post-stroke disability that negatively impacts the QoL. Aphasia is a very common consequence of stroke, affecting approximately 30% of stroke survivors and significantly limiting rehabilitation.34 According to the IFCN guidelines, to date, there is no recommendation for LF-rTMS of the contralesional right inferior frontal gyrus (IFG). Similarly, no recommendation for HF-rTMS or intermittent theta burst stimulation (TBS) of the ipsilesional left IFG or dorsolateral prefrontal cortex (DLPFC) in Broca’s aphasia has been currently approved.10 The same is true for LF-rTMS of the right superior temporal gyrus in Wernicke’s aphasia.10

Neglect is the incapacity to respond to tactile or visual contralateral stimuli that are not caused by a sensory-motor deficit.35 Although hard to treat, rTMS has been proposed as a tool for neglect rehabilitation.36 However, the IFCN guidelines state that currently there is no recommendation for LF-rTMS of the contralesional left posterior parietal cortex, or for HF-rTMS of the ipsilesional right posterior parietal cortex.10 In a recent systematic review, most of the included studies supported the use of TMS for the rehabilitation of aphasia, dysphagia, and neglect, although the heterogeneity of stimulation protocols did not allow definitive conclusions to be drawn.37

Post-stroke depression is a relevant complication of cerebrovascular diseases.38 The role of rTMS in the management of major depressive disorders is well documented,39,40 and currently, rTMS is internationally approved and indicated for the treatment of major depression in adults with antidepressant medication resistance, and in those with a recurrent course of illness, or in cases of moderate-to-severe disease severity.39 In major depression disorders, according to the IFCN guidelines, there is a clear antidepressant effect of HF-rTMS over the left DLPFC, a probable antidepressant effect of LF-rTMS on the right DLPFC, and probably no differential antidepressant effect between right LF-rTMS and left HF-rTMS. Moreover, there is currently no recommendation for bilateral stimulation combining HF-rTMS of the left DLPFC and LF-rTMS of the right DLPFC. The mentioned guidelines also state that the antidepressant effect when stimulating DLPFC is probably additive, and possibly potentiating, to the efficacy of antidepressant drugs.10 However, no specific recommendation currently addresses the use of rTMS in post-stroke depression. Recently, rTMS has been proposed as a treatment option for the late-life depression associated with chronic subcortical ischemic vascular disease, the so called ‘vascular depression’.4144 Three studies tested rTMS efficacy in vascular depression (one was a follow-up study with citalopram). Although presenting positive findings, further trials should refine clinical and diagnostic criteria to assess its impact on antidepressant efficacy.45

Approximately 25–30% of stroke patients develop an immediate or delayed cognitive impairment or an overt picture of vascular dementia.46 There is evidence of an overall positive effect on cognitive function for both LF-rTMS47 and HF-rTMS,48 supported by studies on experimental models of vascular dementia.4952 Nonetheless, the few trials examining the effect on stroke-related cognitive deficit produced mixed results.5356 In particular, two studies found no effect on cognition when stimulating the left DLPFC at 1 Hz and 10 Hz,53,54 whereas a pilot study found a positive effect on the Stroop interference test with HF-rTMS over the left DLPFC in patients with vascular cognitive impairment without dementia.55 However, this finding was not replicated in a follow-up study.56 To summarize, rTMS can induce beneficial effects on specific cognitive domains, although data are limited and their clinical significance needs to be further validated. Major challenges exist in terms of appropriate patient selection and optimization of the stimulation protocols.57

Central post-stroke pain (CPSP) is the pain resulting from an ischemic lesion of the central nervous system.58 It represents a relatively common complication after a stroke, although it is often under-recognized and, therefore, undertreated.59 According to the IFCN guidelines for the use of rTMS in the treatment of neuropathic pain, there is a definite analgesic effect of HF-rTMS of contralateral M1 to the pain side, and LF-rTMS of contralateral M1 to the pain side is probably ineffective. In addition, there is currently no recommendation for cortical targets other than contralateral M1 to the pain side.10 Notably, rTMS might be effective in drug-resistant CPSP patients.58 A recent systematic review that included nine HF-rTMS studies suggested an effect on CPSP relief, but also underlined the insufficient quality of the studies considered.60

Study objective

In this article, we aim to provide an up-to-date overview of the most recent evidence on the efficacy of rTMS in the rehabilitation of stroke patients. Although several studies have been published, a conclusive statement supporting a systematic use of rTMS in the multifaceted clinical aspects of stroke rehabilitation is still lacking.

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Continue —> Repetitive transcranial magnetic stimulation in stroke rehabilitation: review of the current evidence and pitfalls – Francesco Fisicaro, Giuseppe Lanza, Alfio Antonio Grasso, Giovanni Pennisi, Rita Bella, Walter Paulus, Manuela Pennisi, 2019

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