Posts Tagged Spasticity

[BLOG POST] PathMaker Neurosystems – Publication of First Clinical Trial Results for MyoRegulator® Device for Non-Invasive Treatment of Spasticity

PathMaker Neurosystems Inc. (“PathMaker”), a clinical-stage bioelectronic medicine company developing breakthrough non-invasive systems for the treatment of patients with spasticity and paralysis has announced the first publication of clinical trial results for its MyoRegulator® device for the non-invasive treatment of spasticity. Published in Bioelectronic Medicine, the results provide the first clinical evidence using MyoRegulator to treat upper extremity spasticity in subjects with chronic stroke. MyoRegulator is an investigational medical device and is limited by US Federal law to investigational use only.

Spasticity is a chronic condition characterised by painful muscle contractions and is common in patients suffering from stroke, cerebral palsy, multiple sclerosis, spinal cord injury, traumatic brain injury and other neurological disorders. Management of spasticity is a difficult challenge and is currently managed primarily by pharmacological agents and injected botulinum neurotoxins, and there is tremendous unmet medical need.  MyoRegulator is a first-in-class non-invasive device based on PathMaker’s proprietary DoubleStim™ technology (combining anodal trans-spinal direct current stimulation (tsDCS) and peripheral nerve direct current stimulation (pDCS)), which provides simultaneous non-invasive stimulation intended to suppress hyperexcitable spinal neurons involved with spasticity.

“Current pharmacological approaches to managing spasticity have, at best, short-term efficacy, are confounded by adverse effects, and are often unpleasant for the patient,” said co-author Zaghloul Ahmed, Ph.D., Professor and Chairman, Department of Physical Therapy and Professor, Center for Developmental Neuroscience, CUNY and Scientific Founder of PathMaker Neurosystems. “The initial study results demonstrate the potential of a novel, non-invasive treatment to reduce spasticity and improve functional recovery in patients with upper motor neuron syndrome after stroke.”

The publication, Non-Invasive Treatment of Patients with Upper Extremity Spasticity Following Stroke Using Paired Trans-spinal and Peripheral Direct Current Stimulation, was authored by researchers at Feinstein Institute for Medical Research at Northwell Health (Manhasset, NY) led by Bruce Volpe, M.D. The study included patients with upper limb hemiparesis and wrist spasticity at least 6 months after their initial stroke in a single-blind, sham-controlled, crossover design study to test whether MyoRegulator treatment reduces chronic upper-extremity spasticity.

Twenty subjects received five consecutive 20-minute daily treatments with sham stimulation followed by a 1-week washout period, then five consecutive 20-minute daily treatments with active stimulation. Subjects were told that the order of active or sham stimulation would be randomized. Clinical and objective measures of spasticity and motor function were collected before the first session of each condition (baseline), immediately following the last session of each condition, and weekly for 5 weeks after the completion of active treatments. The results demonstrated significant group mean reductions from baseline in both Modified Tardieu Scale scores (summed across the upper limb, P<0.05), and in objectively measured muscle resistance at the wrist flexor (P<0.05) following active treatment as compared to following sham treatment. Motor function also improved significantly (measured by the Fugl-Meyer and Wolf Motor Function Test; P<0.05 for both tests) after active treatment, even without additional prescribed activity or training. The effect of the active MyoRegulator treatment was durable for the 5-week follow-up period.

We are highly encouraged by these clinical results which demonstrate the potential of MyoRegulator to improve outcomes for patients suffering from spasticity, without the need for surgery or drugs. Building on these results and our ongoing clinical trial in Europe, we expect to initiate a US multi-center, pivotal, double-blind clinical trial supported by the National Institute of Neurological Disorders and Stroke (NINDS) in early 2020.

Nader Yaghoubi, M.D., Ph.D., President and Chief Executive Officer of PathMaker

 

About PathMaker Neurosystems Inc.

PathMaker Neurosystems is a clinical stage bioelectronic medicine company developing breakthrough non-invasive systems for the treatment of patients with chronic neuromotor conditions. With offices in Boston (US) and Paris (France), we are collaborating with world-class institutions to rapidly bring to market disruptive products for treating spasticity, paralysis and muscle weakness. In January 2019, we announced a collaboration and distribution agreement with WeHealth Digital Medicine to commercialise the MyoRegulator® device worldwide, excluding US and Japan territories retained by PathMaker.  More than 48 million patients in the US, Europe and China suffer disabilities due to stroke, cerebral palsy, multiple sclerosis, spinal cord injury, traumatic brain injury, Parkinson’s disease and other neurological disorders. At PathMaker, we are opening up a new era of non-invasive neurotherapy for patients suffering from chronic neuromotor conditions. For more information, please visit the company website at www.pmneuro.com.

Source: PathMaker Neurosystems Inc.

via PathMaker Neurosystems – Publication of First Clinical Trial Results for MyoRegulator® Device for Non-Invasive Treatment of Spasticity | ACNR | Online Neurology Journal

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[WEB SITE] About Mollii – Mollii

What is Mollii?


Mollii is a suit consisting of a pair of trousers, a jacket and a detachable control unit. The Mollii garments includes 58 imbedded electrodes, positioned to stimulate 40 key muscles in the body. Through a low frequency electro-stimulation therapy, Mollii relaxes spastic, tense and aching muscles safely and simply. Programmed after each person’s needs, Mollii prevents and counteracts different forms of muscle shortening and rigidity, helps the user regain control over muscular tension, and reduces pain related to spasticity. In addition, through electro-stimulation settings, Mollii may facilitate the activation of muscles, and thereby may facilitate muscle contractions, which in turn enable movements.

Who uses Mollii?


MG_8180_Svart_OK-1024x683Mollii is used by people who suffer from spasticity and spasticity-related pain, which is typically found in people with cerebral palsy, stroke, multiple sclerosis, spinal cord injury, acquired brain damages and other neurological injuries that result from or create motor disabilities, and generally induce pain. Mollii is used both by adults and children; and is available in men and women sizes starting from 104 cm. up to XXXL.

Mollii can be used in both a home and clinic environment; and is simple to use for all ages. Users dress-up with a Mollii the same way they would with an ordinary garment. There is a button for on/off and a button for play/ pause. A single push of the button starts the muscle stimulation, which proceeds automatically for 60 minutes, and has a lasting positive effect for up to 48 hours.”

How does it work?


Mollii stimulates the antagonist to the spastic muscle. If the bicep is spastic, the tricep is stimulated, which in turn makes the bicep relaxed. Relaxing the muscle enables active movements and a gradual improvement in function, while the body keeps this positive effect for up to 48 hours. The physiological mechanism is called reciprocal inhibition.

Mollii also reduces pain related to spasticity, both through the reciprocal inhibition, and via the gate control theory of pain, which asserts that non-painful input such as the electric stimulation of skin-nerves closes the nerve-gates to painful input, which prevents pain sensation from traveling to the central nervous system.

Moreover, Mollii may facilitate the sub-threshold stimulation of a muscle by preparing the muscle for contraction before generating a shortening of the muscle, thereby reducing the nerve signal-strength required by the patient to actually generate a muscle contraction.

It is a safe and simple assistive device that can increase quality of life and help recover faster motor functions. The device is used for one hour every second day. For optimum effect, Mollii should be used together with physiotherapy, training, activity and movement. The positive effect is individual and remains for up to 48 hours.

Want more information?


Mollii Product Sheet

Frequently asked questions

Who is Mollii for? Mollii is an assistive device for people with spasticity and other forms of motor impairment due to cerebral palsy, stroke, brain damage, spinal cord injury or other neurological injuries. Molli can also be used to alleviate spasticity related pain.
How does the Mollii suit work? Molli is a functional garment that consists of a pair of trousers, a jacket and a detachable control unit which sends electrical signals to the user via electrodes on the inside of the garment. The suit has 58 electrodes which can be combined in various ways. Mollii has a control unit which is individually programmed for each user. The person prescribing Mollii uses a computer program to adapt the active electrodes and the intensity (which muscles are to be activated by means of current). The settings are then saved in the Mollii control unit, making it simple for the device to be used at home.
What happens in the body when Mollii is used? Mollii uses low level electric current to produce basic tension in the musculature. The current stimulates the antagonist to the spastic muscle. If, for example, the biceps is spastic, the triceps is stimulated which in turn makes the biceps relax. Relaxing the muscle enables active movement and a gradual improvement in function. The physiological mechanism is called reciprocal inhibition.
What sizes are available for the Mollii suit? Available in 24 sizes for children from size CL 104 to ladies and mens sizes. Children (CL): 104, 110, 116, 122, 128, 134, 140, 146, 152 Ladies: XS, S, M, L, XL, XXL, XXXL, SXL Mens: XS, S, M, L, XL, XXL, XXXL
Is the Mollii suit User-friendly? Mollii is a functional assistive device that is designed to be used in the home environment. It is simple to use. If a person can put on an ordinary garment him/herself, then he/she can put Mollii on him/herself. There is a button for on/off and a button for play/ pause. A single push of the button starts muscle stimulation, which proceeds automatically for 60 minutes. The device is used for one hour every second day.
How often should the Mollii suit be used? The device is used for approximately one hour on 3-4 occasions per week. For optimum effect, Mollii should be used together with physiotherapy, training, activity and movement. The effect is individual and remains for up to 48 hours.
Mollii suit Safety Mollii is not to be used with electrical implanted devices or medical devices that are affected by magnets, such as shunts. Consult a doctor at: cardiovascular disease, malignancy (cancer), infectious disease, fever, pregnancy, rashes or skin problems and if Mollii is intended for use with other medical devices or other medical treatment. The product is to be used according to the user manual.
What is included with the mollii suit Supplied with: Jacket, trousers, control unit (with bag), belt, laundry bag and user manual.
Mollii suit Washing instructions 40 degrees delicate wash once per month. In between the garment can be hand washed in lukewarm water.
10 Mollii Technical information Power supply: 4 batteries (AAA) Voltage: 20 V Pulse width: 25-175 us Frequency: 20 Hz Pulse apperance: Square wave Channels: 40 Electrodes: 58 Electrode material: Silicone rubber Fabric material: Nylon 82 %, Spandex 18 %

via About Mollii – Mollii

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[WEB PAGE] Results from MyoRegulator for Spasticity Trial Published

myoregulator

Results from a clinical trial testing the MyoRegulator device for the non-invasive treatment of spasticity, published recently in Bioelectronic Medicine, suggest evidence for using MyoRegulator to treat upper extremity spasticity in subjects with chronic stroke, PathMaker Neurosystems Inc announces.

PathMaker Neurosystems Inc is a clinical-stage bioelectronic medicine company that develops non-invasive systems for the treatment of patients with spasticity and paralysis. The MyoRegulator is an investigational medical device and is limited by US Federal law to investigational use only.

The device is based on PathMaker’s proprietary DoubleStim technology (combining anodal trans-spinal direct current stimulation (tsDCS) and peripheral nerve direct current stimulation (pDCS)), which provides simultaneous non-invasive stimulation intended to suppress hyperexcitable spinal neurons involved with spasticity, the company explains in a media release.

“Current pharmacological approaches to managing spasticity have, at best, short-term efficacy, are confounded by adverse effects, and are often unpleasant for the patient,” said co-author Zaghloul Ahmed, PhD, professor and chairman, Department of Physical Therapy and Professor, Center for Developmental Neuroscience, CUNY and Scientific Founder of PathMaker Neurosystems.

“The initial study results demonstrate the potential of a novel, non-invasive treatment to reduce spasticity and improve functional recovery in patients with upper motor neuron syndrome after stroke.”

The single-blind, sham-controlled, crossover design study, authored by researchers at Feinstein Institute for Medical Research at Northwell Health (and led by Bruce Volpe, MD, included patients with upper limb hemiparesis and wrist spasticity at least 6 months after their initial stroke to test whether MyoRegulator treatment reduces chronic upper-extremity spasticity.

Twenty subjects received five consecutive 20-minute daily treatments with sham stimulation followed by a 1-week washout period, then five consecutive 20-minute daily treatments with active stimulation. Subjects were told that the order of active or sham stimulation would be randomized.

Clinical and objective measures of spasticity and motor function were collected before the first session of each condition (baseline), immediately following the last session of each condition, and weekly for 5 weeks after the completion of active treatments.

The results demonstrated significant group mean reductions from baseline in both Modified Tardieu Scale scores (summed across the upper limb, P<0.05), and in objectively measured muscle resistance at the wrist flexor (P<0.05) following active treatment as compared to following sham treatment.

Motor function also improved significantly (measured by the Fugl-Meyer and Wolf Motor Function Test; P<0.05 for both tests) after active treatment, even without additional prescribed activity or training. The effect of the active MyoRegulator treatment was durable for the 5-week follow-up period, the release continues.

“We are highly encouraged by these clinical results which demonstrate the potential of MyoRegulator to improve outcomes for patients suffering from spasticity, without the need for surgery or drugs,” says Nader Yaghoubi, MD, PhD, president and chief executive officer of PathMaker.

“Building on these results and our ongoing clinical trial in Europe, we expect to initiate a US multi-center, pivotal, double-blind clinical trial supported by the National Institute of Neurological Disorders and Stroke (NINDS) in early 2020.”

[Source: PathMaker Neurosystems Inc]

 

via Results from MyoRegulator for Spasticity Trial Published – Rehab Managment

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[Abstract + References] Investigation of the effects of mirror therapy on the spasticity, motor function and functionality of impaired upper limbs in chronic stroke patients

Background/Aims

Strokes lead to different levels of disability. During the chronic stage, hemiparesis, spasticity and motor deficits may cause loss of functional independence. Mirror therapy aims to reduce deficits and increase functional recovery of the impaired upper limb. This study aimed to evaluate the effects of mirror therapy on upper limb spasticity and motor function, as well as its impact on functional independence in chronic hemiparetic patients.

Methods

In this quasi-experimental study, eight chronic hemiparetic patients (age 55.5 ± 10.8 years) were assessed to determine their degree of spasticity (Modified Ashworth Scale), level of upper limb motor function (Fugl-Meyer Assessment) and functionality (Functional Independence Measure). All participants received 12 sessions of mirror therapy delivered three times per week, over a period of 4 weeks. Participants were re-evaluated post-intervention and these results were compared to their pre-intervention scores to determine the impact of mirror therapy.

Results

A decrease in spasticity was observed, with significant improvements in shoulder extensors (P=0.033) and a significant increase in motor function (P=0.002). The therapeutic protocol adopted did not have a significant effect on functional independence (P=0.105).

Conclusions

Mirror therapy led to improvements in upper limb spasticity and motor function in chronic hemiparetic stroke patients. No effects on functional independence were observed. Further research with a larger number of patients is needed to provide more robust evidence of the benefits of mirror therapy in chronic hemiparetic stroke patients.

 

References

via Investigation of the effects of mirror therapy on the spasticity, motor function and functionality of impaired upper limbs in chronic stroke patients | International Journal of Therapy and Rehabilitation

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[Abstract] Selective peripheral neurolysis using high frequency ultrasound imaging: a novel approach in the treatment of spasticity

 

BACKGROUND: Chemoneurolysis is used to treat focal spasticity in patients with upper motor neuron syndrome.
CASE REPORT: Neurolytic substances (phenol/alcohol) injected nearby/in the main trunk of peripheral nerves can cause not only motor but also cutaneous nerves destruction. The latter is thought to be responsible for considerable side effects such as dysesthesia and paresthesia. During injections, targeting the primary motor branches originating from the main trunk while sparing cutaneous nerves will result in decrease/elimination of these side effects and better clinical improvement.
CLINICAL REHABILITATION IMPACT: We suggest that high frequency ultrasound enabling the physician to scan peripheral nerves and their primary branches can be useful to perform this selective peripheral neurolysis in the treatment of spasticity.

via Selective peripheral neurolysis using high frequency ultrasound imaging: a novel approach in the treatment of spasticity – European Journal of Physical and Rehabilitation Medicine 2019 August;55(4):522-5 – Minerva Medica – Journals

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

Adult using TENS machine for lower limb pain

Published on 26 February 2019

doi: 10.3310/signal-000738

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

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

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

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

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

Why was this study needed?

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

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

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

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

What did this study do?

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

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

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

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

What did it find?

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

What does current guidance say on this issue?

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

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

What are the implications?

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

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

There was insufficient evidence to support use for upper limbs.

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

Citation and Funding

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

No funding information was provided for this study.

Bibliography

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

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

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

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

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

 

  1. Analysis of the Faster Knee-Jerk In the Hemiplegic Limb
    TAKAO NAKANISHI et al., JAMA Neurology, 1965
  2. Transcutaneous Electrical Stimulation
    WILLIAM BAUER et al., JAMA Otolaryngology Head Neck Surgery, 1986

via Transcutaneous electrical stimulation (TENS) may help lower limb spasticity after stroke

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

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 Kinesiotaping on managing spasticity of upper extremity and motor performance in patients with subacute stroke.
DESIGN: A Randomized Controlled Pilot Study.
SETTING: One hospital center.
POPULATION: Participants with stroke within six months.
METHODS: Thirty-one participants were enrolled. Patients were randomly allocated into Kinesiotaping (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: Kinesiotaping could provide some benefits in reducing spasticity and in improving motor performance on the affected hand in patients with subacute stroke.
CLINICAL REHABILITATION IMPACT: Kinesiotaping could be a choice for clinical practitioners to use for effectively managing post-stroke spasticity.

via Effects of kinesiotaping on hemiplegic hand in patients with upper limb post-stroke spasticity: a randomized controlled pilot study – European Journal of Physical and Rehabilitation Medicine 2019 Jun 13 – Minerva Medica – Journals

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[ARTICLE] Personalized upper limb training combined with anodal-tDCS for sensorimotor recovery in spastic hemiparesis: study protocol for a randomized controlled trial – Full Text

Abstract

Background

Recovery of voluntary movement is a main rehabilitation goal. Efforts to identify effective upper limb (UL) interventions after stroke have been unsatisfactory. This study includes personalized impairment-based UL reaching training in virtual reality (VR) combined with non-invasive brain stimulation to enhance motor learning. The approach is guided by limiting reaching training to the angular zone in which active control is preserved (“active control zone”) after identification of a “spasticity zone”. Anodal transcranial direct current stimulation (a-tDCS) is used to facilitate activation of the affected hemisphere and enhance inter-hemispheric balance. The purpose of the study is to investigate the effectiveness of personalized reaching training, with and without a-tDCS, to increase the range of active elbow control and improve UL function.

Methods

This single-blind randomized controlled trial will take place at four academic rehabilitation centers in Canada, India and Israel. The intervention involves 10 days of personalized VR reaching training with both groups receiving the same intensity of treatment. Participants with sub-acute stroke aged 25 to 80 years with elbow spasticity will be randomized to one of three groups: personalized training (reaching within individually determined active control zones) with a-tDCS (group 1) or sham-tDCS (group 2), or non-personalized training (reaching regardless of active control zones) with a-tDCS (group 3). A baseline assessment will be performed at randomization and two follow-up assessments will occur at the end of the intervention and at 1 month post intervention. Main outcomes are elbow-flexor spatial threshold and ratio of spasticity zone to full elbow-extension range. Secondary outcomes include the Modified Ashworth Scale, Fugl-Meyer Assessment, Streamlined Wolf Motor Function Test and UL kinematics during a standardized reach-to-grasp task.

Discussion

This study will provide evidence on the effectiveness of personalized treatment on spasticity and UL motor ability and feasibility of using low-cost interventions in low-to-middle-income countries.

Background

Stroke is a leading cause of long-term disability. Up to 85% of patients with sub-acute stroke present chronic upper limb (UL) sensorimotor deficits [1]. While post-stroke UL recovery has been a major focus of attention, efforts to identify effective rehabilitation interventions have been unsatisfactory. This study focuses on the delivery of personalized impairment-based UL training combined with low-cost state-of-the-art technology (non-invasive brain stimulation and commercially available virtual reality, VR) to enhance motor learning, which is becoming more readily available worldwide.

A major impairment following stroke is spasticity, leading to difficulty in daily activities and reduced quality of life [2]. Studies have identified that spasticity relates to disordered motor control due to deficits in the ability of the central nervous system to regulate motoneuronal thresholds through segmental and descending systems [34]. In the healthy nervous system, the motoneuronal threshold is expressed as the “spatial threshold” (ST) or the specific muscle length/joint angle at which the stretch reflex and other proprioceptive reflexes begin to act [567]. The range of ST regulation in the intact system is defined by the task-specific ability to activate muscles anywhere within the biomechanical joint range of motion (ROM). However, to relax the muscle completely, ST has to be shifted outside of the biomechanical range [8].

After stroke, the ability to regulate STs is impaired [3] such that the upper angular limit of ST regulation occurs within the biomechanical range of the joint resulting in spasticity (spasticity zone). Thus, resistance to stretch of the relaxed muscle has a spatial aspect in that it occurs within the defined spasticity zone. In other joint ranges, spasticity is not present and normal reciprocal muscle activation can occur (active control zone; [4] Fig. 1). This theory-based intervention investigates whether recovery of voluntary movement is linked to recovery of ST control.[…]

Continue —> Personalized upper limb training combined with anodal-tDCS for sensorimotor recovery in spastic hemiparesis: study protocol for a randomized controlled trial | Trials | Full Text

Fig. 3Jintronix virtual reality (VR) games used in the intervention. a Fish Frenzy game requires the player to trace a three-dimensional (3D) trajectory by moving a fish on the screen in different shapes. b Kitchen Cleanup game requires forward reaching towards kitchen cutlery and returning them to shelves and drawers. c Garden Grab game requires lateral reaching while planting seeds, harvesting and transferring tomatoes to baskets. d Catch, Carry, Drop game requires bilateral coordination while catching apples, carrying and dropping them into a container

 

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[Abstract] When does spasticity in the upper limb develop after a first stroke? A nationwide observational study on 861 stroke patients

Highlights

  • The post-stroke spasticity of upper limb can cause significant functional impairment.
  • This study for spasticity was a nationwide multicenter study in South Korea.
  • The median time to develop upper limb spasticity after stroke onset was 34 days.
  • The 13% of post-stroke spasticity cases developed after 90 days from onset.

Abstract

This study investigated the time taken for upper extremity spasticity to develop and its regional difference after first-ever stroke onset in a nationwide multicenter study in South Korea. The retrospective observational study included 861 individuals with post-stroke spasticity in the upper limbs. Spasticity in the upper extremity joints was defined as a modified Ashworth Scale score ≥1. The median time to develop upper limb spasticity after stroke onset was 34 days. 12% of post-stroke spasticity cases developed between 2 months and 3 months and 13% developed after 3 months from onset. At the time of diagnosis of spasticity, most patients showed only a slight increase in muscle tone, which was observed most frequently in the elbow, followed by the wrist, and fingers. Younger stroke survivors were more spastic, and the severity of spasticity increased with time. Approximately half of the patients with post-stroke spasticity developed spasticity during the first month. However, post-stroke spasticity can develop more than 3 months after stroke onset. Therefore, it is important to assess spasticity, even in the chronic state.

via When does spasticity in the upper limb develop after a first stroke? A nationwide observational study on 861 stroke patients – Journal of Clinical Neuroscience

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[Abstract + References] Effect of Transcutaneous Electrical Nerve Stimulation on Spasticity in Adults With Stroke: A Systematic Review and Meta-analysis

Abstract

Objectives

(1) To determine the effect of transcutaneous electrical nerve stimulation (TENS) on poststroke spasticity. (2) To determine the effect of different parameters (intensity, frequency, duration) of TENS on spasticity reduction in adults with stroke. (3) To determine the influence of time since stroke on the effectiveness of TENS on spasticity.

Data Sources

PubMed, PEDro, CINAHL, Web of Science, CENTRAL, and EMBASE databases were searched from inception to March 2017.

Study Selection

Randomized controlled trial (RCT), quasi-RCT, and non-RCT were included if (1) they evaluated the effects of TENS for the management of spasticity in participants with acute or subacute or chronic stroke using clinical and neurophysiological tools; and (2) TENS was delivered either alone or as an adjunct to other treatments.

Data Extraction

Two authors independently screened and extracted data from 15 of the 829 studies retrieved through the search using a pilot tested pro forma. Disagreements were resolved through discussion with other authors. Quality of studies was assessed using Cochrane risk of bias criteria.

Data Synthesis

Meta-analysis was performed using a random-effects model that showed (1) TENS along with other physical therapy treatments was more effective in reducing spasticity in the lower limbs compared to placebo TENS (SMD −0.64; 95% confidence interval [95% CI], −0.98 to −0.31; P=.0001; I2=17%); and (2) TENS, when administered along with other physical therapy treatments, was effective in reducing spasticity when compared to other physical therapy interventions alone (SMD −0.83; 95% CI, −1.51 to −0.15; P=.02; I2=27%). There were limited studies to evaluate the effectiveness of TENS for upper limb spasticity.

Conclusion

There is strong evidence that TENS as an adjunct is effective in reducing lower limb spasticity when applied for more than 30 minutes over nerve or muscle belly in chronic stroke survivors (review protocol registered at PROSPERO: CRD42015020151)

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source:
https://www.archives-pmr.org/article/S0003-9993(18)31455-2/abstract

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