Posts Tagged spasticity

[Abstract] Robot-assisted mirroring exercise as a physical therapy for hemiparesis rehabilitation

Abstract:

The paper suggests a therapeutic device for hemiparesis that combines robot-assisted rehabilitation and mirror therapy. The robot, which consists of a motor, a position sensor, and a torque sensor, is provided not only to the paralyzed wrist, but also to the unaffected wrist to induce a symmetric movement between the joints. As a user rotates his healthy wrist to the direction of either flexion or extension, the motor on the damaged side rotates and reflects the motion of the normal side to the symmetric angular position. To verify performance of the device, five stroke patients joined a clinical experiment to practice a 10-minute mirroring exercise. Subjects on Brunnstrom stage 3 had shown relatively high repulsive torques due to severe spasticity toward their neutral wrist positions with a maximum magnitude of 0.300kgfm, which was reduced to 0.161kgfm after the exercise. Subjects on stage 5 practiced active bilateral exercises using both wrists with a small repulsive torque of 0.052kgfm only at the extreme extensional angle. The range of motion of affected wrist increased as a result of decrease in spasticity. The therapeutic device not only guided a voluntary exercise to loose spasticity and increase ROM of affected wrist, but also helped distinguish patients with different Brunnstrom stages according to the size of repulsive torque and phase difference between the torque and the wrist position.

Source: Robot-assisted mirroring exercise as a physical therapy for hemiparesis rehabilitation – IEEE Conference Publication

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[ARTICLE] A randomised controlled cross-over double-blind pilot study protocol on THC:CBD oromucosal spray efficacy as an add-on therapy for post-stroke spasticity – Full Text

Abstract

Introduction Stroke is the most disabling neurological disorder and often causes spasticity. Transmucosal cannabinoids (tetrahydrocannabinol and cannabidiol (THC:CBD), Sativex) is currently available to treat spasticity-associated symptoms in patients with multiple sclerosis. Cannabinoids are being considered useful also in the treatment of pain, nausea and epilepsy, but may bear and increased risk for cardiovascular events. Spasticity is often assessed with subjective and clinical rating scales, which are unable to measure the increased excitability of the monosynaptic reflex, considered the hallmark of spasticity. The neurophysiological assessment of the stretch reflex provides a precise and objective method to measure spasticity. We propose a novel study to understand if Sativex could be useful in reducing spasticity in stroke survivors and investigating tolerability and safety by accurate cardiovascular monitoring.

Methods and analysis We will recruit 50 patients with spasticity following stroke to take THC:CBD in a double-blind placebo-controlled cross-over study. Spasticity will be assessed with a numeric rating scale for spasticity, the modified Ashworth scale and with the electromyographical recording of the stretch reflex. The cardiovascular risk will be assessed prior to inclusion. Blood pressure, heart rate, number of daily spasms, bladder function, sleep disruption and adverse events will be monitored throughout the study. A mixed-model analysis of variance will be used to compare the stretch reflex amplitude between the time points; semiquantitative measures will be compared using the Mann-Whitney test (THC:CBD vs placebo) and Wilcoxon test (baseline vs treatment).

Introduction

Stroke is one of the most disabling neurological disease and frequently determines important chronic consequences such as spasticity. Prevalence of poststroke spasticity ranges from 4% to 42.6%, with the prevalence of disabling spasticity ranging from 2% to 13%.1 Treatment of poststroke spasticity is based on rehabilitation, local injection of botulinum toxin (BoNT) in the affected muscles for focal spasticity and/or use of classic oral drugs such as tizanidine, baclofen, thiocolchicoside and benzodiazepines, which are not always effective and have a good number of possible side effects.

The transmucosal administration of delta-9-tetrahydrocannabinol and cannabidiol (THC and CBD at 1:1 ratio oromucosal spray, Sativex) is able to reduce spasticity acting on endocannabinoid receptors CB1and CB2. This novel drug has been licensed after an extensive clinical trial programme2–4 in adult patients with multiple sclerosis who have shown no significant benefit from other antispasmodic drugs. More than 45 000 patient/years of exposure since its approval in more than 15 EU countries support their antispasticity effectiveness and safety profile in this indication.5 Besides improving spasticity, cannabinoids can be beneficial in reducing pain, chemotherapy-induced nausea and vomiting; moreover, they contribute to reducing seizures and to lowering eye pressure in glaucoma.6Cannabinoids can also exert psychological effects by lowering anxiety levels and inducing sedation or euphoria. Marijuana, which is the main source of cannabinoids, is declared illegal in many countries mostly because of the risk of abuse, dependence and withdrawal syndrome, related to the effect of its high amounts of THC. Several reports support an increased ischaemic stroke risk related to relevant abuse of smoked marijuana7–17 as well as synthetic cannabinoids.18–20 Ischaemic stroke following cannabis involves more frequently basal ganglia and cerebellum where CB1 and CB2 receptors show a higher expression.13

The ‘French Association of the Regional Abuse and Dependence Monitoring Centres Working Group on Cannabis Complications’ warns about the increased cardiovascular risk related to the use of herbal cannabis, mostly consisting of acute coronary syndromes and peripheral arteriopathies, potentially leading to life-threatening conditions.21 The detrimental consequences of cannabinoids could be attributed to the increase in heart rate22 as well as arterial spasms also in the context of a reversible cerebral vasoconstriction syndrome,23 but also vasculitis, postural hypotension and cardioembolism.24

On the other side, some studies support a beneficial effect on stroke evolution of cannabinoid receptors stimulation. In fact, cannabinoid-mediated activation of CB1 and CB2 receptors reduces inflammation and neuronal injury in acute ischaemic stroke.25 Activation of CB2 receptors shows protective effects after ischaemic injury26 and inhibits atherosclerotic plaque progression.27 28

To our knowledge, no correlations have been reported between haemorrhagic stroke and cannabinoids intake. In our opinion, the modification of blood pressure is the most important cannabinoid effect that should be taken into account in patients with a previous haemorrhagic stroke or predisposed to intracranial bleeding. Cannabinoids are indeed capable of inducing blood pressure fluctuations in a specific triphasic pattern (low-high-low) potentially harmful if the patient is with bleeding risk.29Ischaemic disease is not included among THC:CBD oromucosal spray contraindications. However, considering that, to our knowledge, no study has been performed with THC:CBD oromucosal spray on post-stroke spasticity, we believe that a particular caution should be used in stroke patients.

The decision of which method of measure is considered as end point is a major issue in studies involving spasticity. The definition of spasticity provided by Lance is one of the most precise and reliable, focusing on the stretch reflex as the neurophysiological equivalent of spasticity.30 Probably because of technical complexity and required expertise, neurophysiological approaches are rarely adopted. Clinical rating scales such as the modified Ashworth scale (MAS)31 or subjective scores such as the numeric rating scale (NRS) for spasticity are being widely used.32 33 Recent evidence supports the idea that MAS and NRS are indeed useful to quickly rate spasticity in a clinical setting, however NRS provide a very variable and imprecise assessment of many symptoms related to spasticity, but where spasticity itself is probably only a common factor.34 The adoption of stretch reflex as the most appropriate neurophysiological measure of spasticity increases the specificity and reduces the variability of the end point and is particularly suitable for clinical trials.

Our proposal is therefore to assess the efficacy of THC:CBD oromucosal spray in patients with spasticity following stroke as add-on to first-line antispasticity medications with an experimental pilot randomised placebo-controlled cross-over clinical trial using the stretch reflex as primary outcome measure. Prior to inclusion in the study, we propose strict selection criteria in order to reduce the risk of relevant side effects. […]

Continue —>  A randomised controlled cross-over double-blind pilot study protocol on THC:CBD oromucosal spray efficacy as an add-on therapy for post-stroke spasticity | BMJ Open

 

Graphical representation of the study protocol, particularly depicting the cross-over design and the time points. THC/CBD, tetrahydrocannabinol/cannabidiol.

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[REVIEW] INFLUENCE OF TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION ON SPASTICITY, BALANCE, AND WALKING SPEED IN STROKE PATIENTS: A SYSTEMATIC REVIEW AND META-ANALYSIS – Full Text PDF

Objective: To evaluate the influence of transcutaneous electrical nerve stimulation in patients with stroke through a systematic review and meta-analysis.

Methods: PubMed, Embase, Web of Science, EBSCO, and Cochrane Library databases were searched systematically. Randomized controlled trials assessing the effect of transcutaneous electrical nerve stimulation vs placebo transcutaneous electrical nerve stimulation on stroke were included. Two investigators independently searched articles, extracted data, and assessed the quality of included studies. The primary outcome was modified Ashworth scale (MAS). Meta-analysis was performed using the random-effect model.

Results: Seven randomized controlled trials were included in the meta-analysis. Compared with placebo transcutaneous electrical nerve stimulation, transcutaneous electrical nerve stimulation supplementation significantly reduced MAS (standard mean difference (SMD) = –0.71; 95% confidence interval (95% CI) = –1.11 to –0.30; p =0.0006), improved static balance with open eyes (SMD = –1.26; 95% CI = –1.83
to –0.69; p<0.0001) and closed eyes (SMD = –1.74; 95% CI = –2.36 to –1.12; p < 0.00001), and increased walking speed (SMD = 0.44; 95% CI = 0.05 to 0.84; p = 0.03), but did not improve results on the Timed Up and Go Test (SMD = –0.60; 95% CI=–1.22 to 0.03; p = 0.06).

Conclusion: Transcutaneous electrical nerve stimulation is associated with significantly reduced spasticity, increased static balance and walking speed, but has no influence on dynamic balance.

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[Abstract] Effect of Close Kinematic Chain Exercises on Upper Limb Spasticity in Hemiparetic Adult

Abstract

Background: As upper limb spasticity is the major hindrance in quality of life in hemiparesis, this project emphasizes on the effect of close kinematic chain exercises on upper limb spasticity. So, the present study was conducted to find out the effect combined effect of conventional exercises with close kinematic chain exercises on spasticity.

Method: Comparative study was conducted at Krishna College of Physiotherapy, Karad.20 subjects with age group between 40–60 years were taken. Participants of Group A (10) were treated with close kinematic chain exercises along with conventional treatment & GroupB(10)only with conventional treatment. Exclusion criteria of the study was: 1. Associated psychological disorder. 2. Perceptual disorders. 3. Any visual & auditory impairment. 4. Any orthopaedic disorder.

Results: Statistical analysis was done using paired, unpaired ”t’’test, Mann Whitney test and Friedman statistics. The results showed statistically significant reduction in spasticity in group A as compared to group B (p<0.001).

Conclusion: The study shows that close kinematic chain exercises helps in normalizing tone, reducing spasticity in upper extremity hemiparesis.

Source: Indian Journals

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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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[Abstract] Effects of mirror therapy combined with neuromuscular electrical stimulation on motor recovery of lower limbs and walking ability of patients with stroke: a randomized controlled study 

To investigate the effectiveness of mirror therapy combined with neuromuscular electrical stimulation in promoting motor recovery of the lower limbs and walking ability in patients suffering from foot drop after stroke.

Randomized controlled study.

Inpatient rehabilitation center of a teaching hospital.

Sixty-nine patients with foot drop.

Patients were randomly divided into three groups: control, mirror therapy, and mirror therapy + neuromuscular electrical stimulation. All groups received interventions for 0.5 hours/day and five days/week for four weeks.

10-Meter walk test, Brunnstrom stage of motor recovery of the lower limbs, Modified Ashworth Scale score of plantar flexor spasticity, and passive ankle joint dorsiflexion range of motion were assessed before and after the four-week period.

After four weeks of intervention, Brunnstrom stage (P = 0.04), 10-meter walk test (P < 0.05), and passive range of motion (P < 0.05) showed obvious improvements between patients in the mirror therapy and control groups. Patients in the mirror therapy + neuromuscular electrical stimulation group showed better results than those in the mirror therapy group in the 10-meter walk test (P < 0.05). There was no significant difference in spasticity between patients in the two intervention groups. However, compared with patients in the control group, patients in the mirror therapy + neuromuscular electrical stimulation group showed a significant decrease in spasticity (P < 0.001).

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Source: Effects of mirror therapy combined with neuromuscular electrical stimulation on motor recovery of lower limbs and walking ability of patients with stroke: a randomized controlled studyClinical Rehabilitation – Qun Xu, Feng Guo, Hassan M Abo Salem, Hong Chen, Xiaolin Huang, 2017

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[ARTICLE] Practice patterns for spasticity management with phenol neurolysis – Full Text HTML

Abstract

Objective: To present practice patterns for phenol neurolysis procedures conducted for spasticity management.

Design: A retrospective review of 185 persons with spasticity who underwent phenol neurolysis procedures (n = 293) at an academic rehabilitation hospital and clinic. Patient demographics, concomitant spasticity treatments, and procedure relevant information were collected.

Results: The cohort included 71.9% males and 61.6% inpatient procedures. Neurological diagnoses included stroke (41.0%), traumatic brain injury (28.6%) and spinal cord injury (24.3%). Musculoskeletal diagnoses included spastic hemiplegia or paresis (51.3%), tetraplegia (38.4) and paraplegia (9.2%). At the time of phenol neurolysis, most patients (77.5%) received concomitant pharmacological treatments for spasticity. Injection guidance modalities included electrical stimulation and ultrasound (69.3%) or ultrasound only (27.3%). A mean of 3.48 ml of phenol were injected per nerve and 10.95 ml of phenol were used per procedure. Most commonly injected nerves included the obturator nerve (35.8%) and sciatic branches to the hamstrings and adductor magnus (27.0%). Post-phenol neurolysis assessment was recorded in 54.9% of encounters, in which 84.5% reported subjective benefit. Post-procedure adverse events included pain (4.0%), swelling and inflammation (2.7%), dysaesthesia (0.7%) and hypotension (0.7%).

Conclusion: Phenol neurolysis is currently used to reduce spasticity for various functional goals, including preventing contractures and improving gait. Depending on the pattern of spasticity displayed, numerous peripheral nerves in the upper and lower extremities can be targeted for treatment with phenol neurolysis. Further research into its role in spasticity management, including studies exploring its cost-effectiveness and pharmacological and side-effects compared with other treatment options are needed.

Introduction

Characterized by hyperexcitable stretch reflexes that increase muscle tonicity and exaggerate tendon jerks, spasticity is a common motor disorder that follows a variety of central nervous system insults (1). Implicated neurological insults most often include stroke, traumatic brain injury (TBI) or spinal cord injury (SCI). Spasticity is often associated with various complications including joint contractures, muscle shortening and postural deformities (1) that lead to multiple impairments. Early goal-directed spasticity management is instrumental in helping increase the likelihood of good outcomes and limiting complications (1, 2). Unfortunately, a lack of universally standardized management and an abundance of therapeutic options make spasticity management a challenging task.

Currently, spasticity is frequently managed through a combination of therapeutic modalities, pharmaceutical options and surgical procedures (3). Pharmaceutical options include medications delivered orally, via local injections, or through intrathecal pumps. Oral medications, including baclofen and tizanidine, help decrease spasticity (3). However, systemic side-effects, such as generalized muscle weakness, sedation, confusion, and hypotension, preclude the use of higher dosages that might be warranted for control of moderate-to-severe spasticity (3, 4). Intrathecal baclofen pump (ITB) is often indicated in treating severe and/or diffuse spasticity as a means to deliver high-dosage baclofen with less concern for systemic side-effects (4). Although ITB treatment is very effective, numerous complications and the requirement for commitment to maintenance associated with this treatment makes it favourable only for some patients with severe spasticity (4, 5).

Chemoneurolysis via localized injections can help provide focal spasticity relief (1, 3, 6). In addition, the use of single-event multi-level chemoneurolysis helps treat several areas of muscle spasticity, each with varying severities (7). Medications used in chemo-neurolysis procedures include botulinum neurotoxin (BoNT), phenol, and alcohol neurolysis (3–7). Compared with phenol and the understudied alcohol neurolysis, BoNT usage in treating spasticity is documented extensively in the literature with regards to pharmacodynamics, adverse effects and clinical benefits (7–9). However, the response to chemodenervation with BoNT often requires 3–5 days to generate spasticity benefit, which generally lasts approximately 3 months. Although clinical standards permit repeating chemodenervation every 3 months, the majority of patients with spasticity prefer an increased frequency for maintaining clinical benefit (10–12). BoNT injections are associated with significant costs, and repeated injections are often further restricted by financial feasibility. In the USA, depending on the insurance being used, the approved dosage of BoNT is only 400–600 units of every 3 months. These limitations prevent the sole utility of chemodenervation for a multi-pattern treatment, e.g. elbow flexion, clenched fist, stiff knee gait, and equinovarus of the foot. Consequently, phenol neurolysis (PN) and BoNT are used in complement, with PN frequently reserved for proximal nerves and BoNT used for distal musculature.

In contrast, PN produces an almost-immediate effect that manifests within minutes of injection, which may last as long as 6 months depending on the dosage used (1, 13). In addition, PN is significantly less expensive. PN may also be re-injected before 3 months, unlike BoNT. However, the safety and efficacy of PN is less-commonly documented in the literature than BoNT chemodenervation. PN also requires a higher level of expertise to administer, and has a worse side-effect profile, which includes hypotension, prolonged pain, dysaesthesias, site inflammation, and joint fibrosis (1, 13, 14). These disadvantages for phenol usage are associated with safety concerns relative to neurotoxins, thus making BoNT a vastly more popular option for chemoneurolysis. Phenol is therefore being used increasingly less in the USA and is poorly documented in the spasticity literature. Given its advantages, PN may be superior to chemodenervation with BoNT in certain clinical scenarios. Thus, the primary purpose of the current study is to describe the utilization pattern of PN at a single site.

 

Continue —> Journal of Rehabilitation Medicine – Practice patterns for spasticity management with phenol neurolysis – HTML

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[Abstract] The Effect of Modified Constraint-Induced Movement Therapy on Spasticity and Motor Function of the Affected Arm in Patients with Chronic Stroke

Purpose: The purpose of this study was to explore the effect of modified constraint-induced movement therapy (CIMT) in a real-world clinical setting on spasticity and functional use of the affected arm and hand in patients with spastic chronic hemiplegia.

Method: A prospective consecutive quasi-experimental study design was used. Twenty patients with spastic hemiplegia (aged 22–67 years) were tested before and after 2-week modified CIMT in an outpatient rehabilitation clinic and at 6 months. The Modified Ashworth Scale (MAS), active range of motion (AROM), grip strength, Motor Activity Log (MAL), Sollerman hand function test, and Box and Block Test (BBT) were used as outcome measures.

Results: Reductions (p<0.05–0.001) in spasticity (MAS) were seen both after the 2-week training period and at 6-month follow-up. Improvements were also seen in AROM (median change of elbow extension 5°, dorsiflexion of hand 10°), grip strength (20 Newton), and functional use after the 2-week training period (MAL: 1 point; Sollerman test: 8 points; BBT: 4 blocks). The improvements persisted at 6-month follow-up, except for scores on the Sollerman hand function test, which improved further.

Conclusion: Our study suggests that modified CIMT in an outpatient clinic may reduce spasticity and increase functional use of the affected arm in spastic chronic hemiplegia, with improvements persisting at 6 months.

Source: The Effect of Modified Constraint-Induced Movement Therapy on Spasticity and Motor Function of the Affected Arm in Patients with Chronic Stroke | Physiotherapy Canada

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[Abstract] Duration of Treatment Effect of IncobotulinumtoxinA in Upper Limb Spasticity (P4.036)

ABSTRACT

Objective: To assess, the duration of treatment effect for incobotulinumtoxinA treatment intervals using a pooled analysis of 2 phase 3 clinical studies in upper-limb post-stroke spasticity (ULPSS).

Background: The efficacy and safety of incobotulinumtoxinA in ULPSS has been confirmed in 2 phase 3 studies. Study 0410 included a randomized placebo-controlled period and an open-label extension (OLEX). OLEX reinjection intervals were flexible (≥12 week intervals with doses ≤400U). Study 3001 included fixed 12-week treatment intervals (TIs). In study 0410, investigators and subjects mutually determined the need for re-injection on the basis of pre-specified criteria (eg, Ashworth scale scores, investigator’s clinical impression).

Design/Methods: All TIs between 2 consecutive incobotulinumtoxinA injections were included, except TIs prior to the end of study visit and those with doses <300U. Outliers and factors other than a medical need for re-injection (eg, visit scheduling) were accounted for using duration thresholds applied during the analysis; the number of subjects with ≥1 TI above a threshold was calculated.

Results: A total of 347/437 incobotulinumtoxinA TIs met the inclusion criteria (range of re-injection intervals observed: 9–49 weeks). Over half (54.8%) of the re-injections were administered at week ≥14. The mean incobotulinumtoxinA TI was 15.46 weeks (standard devation: 4.63 weeks). A majority of subjects (59.1%) had ≥1 TI with re-injection at week ≥16; 33.1% of subjects had 1, 22.1% had 2 and 3.9% had 3. Many subjects (42.5%) had ≥1 TI with re­-injection at week ≥18.

Conclusions: These results demonstrate variability in the duration of treatment effect, which supports the use of flexible and individualized dosing intervals for the treatment of ULPSS. The duration of treatment effect was ≥14 weeks after most treatments; however, a considerable proportion of patients experienced effects lasting up to 20 weeks.

Source: Duration of Treatment Effect of IncobotulinumtoxinA in Upper Limb Spasticity (P4.036)

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[ARTICLE] Practice patterns for spasticity management with phenol neurolysis – HTML

Abstract

Objective: To present practice patterns for phenol neurolysis procedures conducted for spasticity management.

Design: A retrospective review of 185 persons with spasticity who underwent phenol neurolysis procedures (n = 293) at an academic rehabilitation hospital and clinic. Patient demographics, concomitant spasticity treatments, and procedure relevant information were collected.

Results: The cohort included 71.9% males and 61.6% inpatient procedures. Neurological diagnoses included stroke (41.0%), traumatic brain injury (28.6%) and spinal cord injury (24.3%). Musculoskeletal diagnoses included spastic hemiplegia or paresis (51.3%), tetraplegia (38.4) and paraplegia (9.2%). At the time of phenol neurolysis, most patients (77.5%) received concomitant pharmacological treatments for spasticity. Injection guidance modalities included electrical stimulation and ultrasound (69.3%) or ultrasound only (27.3%). A mean of 3.48 ml of phenol were injected per nerve and 10.95 ml of phenol were used per procedure. Most commonly injected nerves included the obturator nerve (35.8%) and sciatic branches to the hamstrings and adductor magnus (27.0%). Post-phenol neurolysis assessment was recorded in 54.9% of encounters, in which 84.5% reported subjective benefit. Post-procedure adverse events included pain (4.0%), swelling and inflammation (2.7%), dysaesthesia (0.7%) and hypotension (0.7%).

Conclusion: Phenol neurolysis is currently used to reduce spasticity for various functional goals, including preventing contractures and improving gait. Depending on the pattern of spasticity displayed, numerous peripheral nerves in the upper and lower extremities can be targeted for treatment with phenol neurolysis. Further research into its role in spasticity management, including studies exploring its cost-effectiveness and pharmacological and side-effects compared with other treatment options are needed.

Introduction

Characterized by hyperexcitable stretch reflexes that increase muscle tonicity and exaggerate tendon jerks, spasticity is a common motor disorder that follows a variety of central nervous system insults (1). Implicated neurological insults most often include stroke, traumatic brain injury (TBI) or spinal cord injury (SCI). Spasticity is often associated with various complications including joint contractures, muscle shortening and postural deformities (1) that lead to multiple impairments. Early goal-directed spasticity management is instrumental in helping increase the likelihood of good outcomes and limiting complications (1, 2). Unfortunately, a lack of universally standardized management and an abundance of therapeutic options make spasticity management a challenging task.

Currently, spasticity is frequently managed through a combination of therapeutic modalities, pharmaceutical options and surgical procedures (3). Pharmaceutical options include medications delivered orally, via local injections, or through intrathecal pumps. Oral medications, including baclofen and tizanidine, help decrease spasticity (3). However, systemic side-effects, such as generalized muscle weakness, sedation, confusion, and hypotension, preclude the use of higher dosages that might be warranted for control of moderate-to-severe spasticity (3, 4). Intrathecal baclofen pump (ITB) is often indicated in treating severe and/or diffuse spasticity as a means to deliver high-dosage baclofen with less concern for systemic side-effects (4). Although ITB treatment is very effective, numerous complications and the requirement for commitment to maintenance associated with this treatment makes it favourable only for some patients with severe spasticity (4, 5).

Chemoneurolysis via localized injections can help provide focal spasticity relief (1, 3, 6). In addition, the use of single-event multi-level chemoneurolysis helps treat several areas of muscle spasticity, each with varying severities (7). Medications used in chemo-neurolysis procedures include botulinum neurotoxin (BoNT), phenol, and alcohol neurolysis (3–7). Compared with phenol and the understudied alcohol neurolysis, BoNT usage in treating spasticity is documented extensively in the literature with regards to pharmacodynamics, adverse effects and clinical benefits (7–9). However, the response to chemodenervation with BoNT often requires 3–5 days to generate spasticity benefit, which generally lasts approximately 3 months. Although clinical standards permit repeating chemodenervation every 3 months, the majority of patients with spasticity prefer an increased frequency for maintaining clinical benefit (10–12). BoNT injections are associated with significant costs, and repeated injections are often further restricted by financial feasibility. In the USA, depending on the insurance being used, the approved dosage of BoNT is only 400–600 units of every 3 months. These limitations prevent the sole utility of chemodenervation for a multi-pattern treatment, e.g. elbow flexion, clenched fist, stiff knee gait, and equinovarus of the foot. Consequently, phenol neurolysis (PN) and BoNT are used in complement, with PN frequently reserved for proximal nerves and BoNT used for distal musculature.

In contrast, PN produces an almost-immediate effect that manifests within minutes of injection, which may last as long as 6 months depending on the dosage used (1, 13). In addition, PN is significantly less expensive. PN may also be re-injected before 3 months, unlike BoNT. However, the safety and efficacy of PN is less-commonly documented in the literature than BoNT chemodenervation. PN also requires a higher level of expertise to administer, and has a worse side-effect profile, which includes hypotension, prolonged pain, dysaesthesias, site inflammation, and joint fibrosis (1, 13, 14). These disadvantages for phenol usage are associated with safety concerns relative to neurotoxins, thus making BoNT a vastly more popular option for chemoneurolysis. Phenol is therefore being used increasingly less in the USA and is poorly documented in the spasticity literature. Given its advantages, PN may be superior to chemodenervation with BoNT in certain clinical scenarios. Thus, the primary purpose of the current study is to describe the utilization pattern of PN at a single site. […]

Continue —> Journal of Rehabilitation Medicine – Practice patterns for spasticity management with phenol neurolysis – HTML

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