Spasticity Management Teams, Evaluations, and Tools: A Canadian Cross-Sectional Survey.

OBJECTIVE: The objective of this study is to determine the physical evaluations and assessment tools used by a group of Canadian healthcare professionals treating adults with spasticity. METHODS: A cross-sectional web-based 19-question survey was developed to determine the types of physical evaluations, tone-related impairment measurements, and assessment tools used in the management of adults with spasticity. The survey was distributed to healthcare professionals from the Canadian Advances in Neuro-Orthopedics for Spasticity Congress database. RESULTS: Eighty study participants (61 physiatrists and 19 other healthcare professionals) completed the survey and were included. Nearly half (46.3%, 37/80) of the participants reported having an inter- or trans-disciplinary team managing individuals with spasticity. Visual observation of movement, available range of motion determination, tone during velocity-dependent passive range of motion looking for a spastic catch, spasticity, and clonus, and evaluation of gait were the most frequently used physical evaluations. The most frequently used spasticity tools were the Modified Ashworth Scale, goniometer, and Goal Attainment Scale. Results were similar in brain- and spinal cord-predominant etiologies. To evaluate goals, qualitative description was used most (37.5%). CONCLUSION: Our findings provide a better understanding of the spasticity management landscape in Canada with respect to staffing, physical evaluations, and outcome measurements used in clinical practice. For all etiologies of spasticity, visual observation of patient movement, Modified Ashworth Scale, and qualitative goal outcomes descriptions were most commonly used to guide treatment and optimize outcomes. Understanding the current practice of spasticity assessment will help provide guidance for clinical evaluation and management of spasticity.

A Delphi-Based Consensus Statement on the Management of Anticoagulated Patients With Botulinum Toxin for Limb Spasticity.

OBJECTIVE: To create a consensus statement on the considerations for treatment of anticoagulated patients with botulinum toxin A (BoNTA) intramuscular injections for limb spasticity. DESIGN: We used the Delphi method. SETTING: A multiquestion electronic survey. PARTICIPANTS: Canadian physicians (N=39) who use BoNTA injections for spasticity management in their practice. INTERVENTIONS: After the survey was sent, there were e-mail discussions to facilitate an understanding of the issues underlying the responses. Consensus for each question was reached when agreement level was ≥75%. MAIN OUTCOME MEASURES: Not applicable. RESULTS: When injecting BoNTA in anticoagulated patients: (1) BoNTA injections should not be withheld regardless of muscles injected; (2) a 25G or smaller size needle should be used when injecting into the deep leg compartment muscles; (3) international normalized ratio (INR) level should be ≤3.5 when injecting the deep leg compartment muscles; (4) if there are clinical concerns such as history of a fluctuating INR, recent bleeding, excessive or new bruising, then an INR value on the day of injection with point-of-care testing or within the preceding 2-3 days should be taken into consideration when injecting deep compartment muscles; (5) the concern regarding bleeding when using direct oral anticoagulants (DOACs) should be the same as with warfarin (when INR is in the therapeutic range); (6) the dose and scheduling of DOACs should not be altered for the purpose of minimizing the risk of bleeding prior to BoNTA injections. CONCLUSIONS: These consensus statements provide a framework for physicians to consider when injecting BoNTA for spasticity in anticoagulated patients. These consensus statements are not strict guidelines or decision-making steps, but rather an effort to generate common understanding in the absence of evidence in the literature.

Effect of Botulinum Toxin on Clonus: A Systematic Review.

OBJECTIVE: To conduct a systematic review of the literature that examined the effect of botulinum toxin type A on clonus. DATA SOURCES: A literature search of multiple databases (PubMed, Cochrane, Google Scholar, Embase) was performed to identify articles published in English in the past 30 years (1986-2016). STUDY SELECTION: Two reviewers independently applied the following inclusion criteria: (1) any adult patients older than 18 years with upper motor lesion; (2) any location and duration of clonus; and (3) subjective and objective measurements of clonus tested at least 2 weeks after botulinum toxin injection. DATA EXTRACTION: Two reviewers independently extracted the data and assessed the methodological quality. A consensus method was used to solve disagreements. DATA SYNTHESIS: The systematic review resulted in 164 articles, of which 14 met the inclusion criteria: 3 were randomized controlled trials, 1 was nonrandomized, and 6 were case series and 3 case studies. All studies (181 patients) showed improvement in clonus: 6 of 14 results were statistically significant. Different scales were used for clonus measurement, such as clonus score, patient diaries, clonus spasm score, and electromyogram duration. CONCLUSIONS: Overall, there was preliminary evidence indicating improvement in clonus after botulinum injection. The major drawback with studies reviewed here was a large variation in the type of clonus assessment tools, which also lacked validity, reliability, and sensitivity to small changes in clonus.

Physician Preferences for Botulinum Toxin Injections in Anticoagulated Patients with Spasticity.

To understand physician preferences and bleeding complication rates of intramuscular botulinum neurotoxin type A injections for spasticity management in anticoagulated patients, questionnaires were mailed to 138 physicians across Canada. The international normalized ratio comfort range for injections was <2.0 in 10%, 2.0 to 2.5 in 35%, 2.6 to 3.0 in 25%, and 3.1 to 3.5 in 20% of physicians. Only 23% injected outside their comfort value and 57% did not; 72% did not normalize the international normalized ratio value before injections. Only one injector reported the development of compartment syndrome. As expected, high variability exists in physician preferences in botulinum neurotoxin type A injection in anticoagulated patients.

Relationship Between Botulinum Toxin, Spasticity, and Pain: a Survey of Patient Perception.

OBJECTIVE: To assess the prevalence of pain in adults with spasticity and to assess the association between the subjective experience of pain and spasticity. DESIGN: Cross-sectional study. SETTING: outpatient spasticity management clinic of a rehabilitation centre. PATIENTS: Patients with upper motor neuron lesions and spasticity (n=131) were recruited. METHODS: We assessed pain intensity and location, relationship between spasticity and pain perception, and perception of pain relief from botulinum toxin type-A (BoNTA) injections. MAIN OUTCOME MEASURES: Pain perception rated on a 10-point numerical rating scale and pain quality. RESULTS: 65% of the patients with spasticity reported presence of pain and 60% described it as an aching pain. More patients reported pain with movement (34%) compared to rest (21%). There was a statistically poor correlation between the severity of pain and spasticity (r=0.16; p>0.05). Most patients (80%) believed that their pain was related to spasticity and 62% reported that BoNTA injections decreased their pain. CONCLUSIONS: The high incidence of pain noted within our sample suggests that physicians may have to consider pain management as part of spasticity treatment. Participants reported that their pain was related to their spasticity, and that it decreased after BoNTA treatment. Further study is needed to explore the relationships between objective measures of spasticity and pain.

Adverse Clinical Effects of Botulinum Toxin Intramuscular Injections for Spasticity.

OBJECTIVE: The adverse events (AEs) with botulinum toxin type-A (BoNTA), used for indications other than spasticity, are widely reported in the literature. However, the site, dose, and frequency of injections are different for spasticity when compared to the treatment for other conditions and hence the AEs may be different as well. The objective of this study was to summarize the AEs reported in Canada and systematically review the AEs with intramuscular botulinum toxin injections to treat focal spasticity. METHODS: Data were gathered from Health Canada (2009-2013) and major electronic databases. RESULTS: In a 4 year period, 285 AEs were reported. OnabotulinumtoxinA (n=272 events): 68% females, 53% serious, 18% hospitalization, and 8% fatalities. The type of AEs reported were - muscle weakness (19%), oropharyngeal (14%), respiratory (14%), eye related (8%), bowel/bladder related (8%), and infection (5%). IncobotulinumtoxinA (n=13): 38% females, 62% serious, and 54% hospitalization. The type of AEs reported were - muscle weakness (15%), oropharyngeal (15%), respiratory (38%), eye related (23%), bowel/bladder related (15%), and infection (15%). Commonly reported AEs in the literature were muscle weakness, pain, oropharyngeal, bowel/bladder, blood circulation, neurological, gait, and respiratory problems. CONCLUSION: While BoNTA is useful in managing spasticity, future studies need to investigate the factors that can minimize AEs. A better understanding of the underlying mechanisms of the AEs can also improve guidelines for BoNTA administration and enhance outcomes.

Effects of Treadmill Incline and Speed on Ankle Muscle Activity in Subjects After a Stroke.

OBJECTIVES: To examine the effects of walking on a treadmill at varying gradients and speeds on ankle muscle activation in stroke survivors, and to compare the effect of increasing speed on plantarflexor muscle activity in participants grouped according to spasticity severity. DESIGN: Within-subject and cross-sectional design. Participants walked on a standard treadmill at 3 different inclines (0°, 3°, 6°) and speeds (self-selected, self-selected+20%, self selected+40%). SETTING: University laboratory. PARTICIPANTS: A convenience sample of stroke survivors (N=19; 13 men, 6 women) available in university clinics. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Electromyographic activity of medial gastrocnemius (MG) and tibialis anterior (TA) muscles at push-off phase of the gait. RESULTS: Paretic MG muscle activity increased (but TA did not change) at faster speeds irrespective of the incline (P<.05). In contrast, MG muscle activity increased at a higher incline in the nonparetic side (P<.05), but not in the paretic side (P>.05). In the high-spasticity subgroup (Tardieu Scale ≥ 2), paretic MG activity increased as walking speed increased (P=.004). CONCLUSIONS: Stroke survivors appear to use distinct muscle activation strategies on the paretic and nonparetic sides in response to different walking speeds and inclines. Our data indicates that individuals with stroke can be safely trained on a treadmill to walk 20% to 40% above the self-selected pace to improve MG output without adversely affecting TA output. The speed-dependent characteristic of spasticity may help generate greater MG activity during push-off.

Upper-extremity spinal reflex inhibition is reproducible and strongly related to grip force poststroke.

PURPOSE: Impaired reflex regulation is assumed to contribute to upper-extremity motor impairment poststroke; however, the relationship between reflex inhibition and motor function remains unclear. To address this question, it is first necessary to determine the reproducibility of reflex responses. The objective of this study was to establish the test-retest reliability of flexor carpi radialis H-reflex inhibition in healthy control and stroke participants and investigate the correlation between H-reflex inhibition and grip strength. MATERIALS AND METHODS: Eighteen persons poststroke (mean ± SD: age 63 ± 13 years; 6 ± 5 years poststroke; 13 males) and 16 healthy controls (age: 62 ± 12 years) participated. Reflex inhibition was tested on 2 separate days by conditioning the H-reflex with radial nerve stimulation at two different interstimulus intervals: 13 ms (presynaptic Ia inhibition-PSI) and 0 ms (disynaptic inhibition). Pearson's and intraclass correlation coefficients [two-way mixed model-ICC (1, 2)], and standard error of measurement (SEM) were calculated. RESULTS: Relative reliability (ICCs) ranged from good to excellent (0.61-0.78). SEM was low (range 10-19%, stroke; 15-20%, healthy controls). Paretic grip strength and paretic limb PSI revealed a positive correlation (r = 0.70; p < 0.0125). Disynaptic inhibition and paretic grip strength were not correlated. CONCLUSIONS: To our knowledge, this is the first study to demonstrate reproducibility of reflex inhibition in individuals poststroke. Furthermore, we quantify smallest real differences, which provide an estimate of the magnitude of effect required to determine a meaningful change, exceeding measurement error. The correlation between PSI and grip strength suggests the potential contribution of PSI to grip force production and upper-extremity motor function.

The influence of a concurrent cognitive task on lower limb reaction time among stroke survivors with right- or left-hemiplegia.

OBJECTIVE: To determine the impact of cognitive interference on foot pedal reaction time among stroke survivors with right- (RH) or left-hemiplegia (LH). DESIGN: Cross-sectional comparison without randomization. SUBJECTS/PATIENTS: 10 patients post-stroke with RH, 10 with LH; 10 age-matched controls. METHODS: Foot pedal response times were measured using three different reaction time (RT) paradigms: simple RT, dual-task RT (counting backward by serial 3 seconds), and choice RT (correct response contingent on stimuli to eliminate pre-programing). RH and LH used the non-paretic leg for all trials. Three 3 (RT task) × 3 (group) mixed-model factorial ANOVAs were used to compare RT, movement time (MT), total response time (TRT). RESULTS: Overall controls demonstrated faster RT than RH (332 ± 73 versus 474 ± 144 ms, P < 0.001) or LH (402 ± 127 ms, P < 0.05); LH group demonstrated faster RT than those with RH (P < 0.05). Control subjects demonstrated significantly faster RT than RH for all RT conditions (P < 0.05 for all). In contrast, controls achieved significantly faster RT than LH for the choice RT condition only (P < 0.05), but not for the simple (P = 0.12) or dual-task RT conditions (P = 0.25). CONCLUSIONS: Compared to controls, response time was significantly impaired among LH and RH when the response could not be pre-programmed. While current simple RT testing commonly employed by driver rehab specialists may be sufficient for detecting RT deficits in patients with RH, simple or dual-task RT tests alone may fail to detect RT deficiencies among LH, even when testing the non-paretic limb. Choice RT should be added to post-stroke driver fitness assessment, particularly for patients with LH.

Comparison of foot pedal reaction time among patients with right or left hemiplegia and able-bodied controls.

BACKGROUND: Although inpatient stroke rehabilitation provides clinicians with the opportunity to prepare patients for continuation of prestroke activities, little is known about the patients' ability to safely resume driving at the point of discharge to the community. OBJECTIVE: To compare foot pedal response times of 20 stroke patients with right hemiplegia (RH) or left hemiplegia (LH) and 10 controls. METHODS: A cross-sectional design was used. Response times were measured using 3 foot pedal operation techniques: (1) right-sided accelerator with right leg operating accelerator and brake, (2) right-sided accelerator with left leg operating accelerator and brake, and (3) left-sided accelerator with left leg operating accelerator and brake. Outcomes included reaction time (RT), movement time (MT), and total response time (TRT). RESULTS: Controls demonstrated faster RT than patients with RH (263 vs 348 ms; P < .001) or LH (316 ms; P < .05) for all conditions, as well as faster MT than patients with RH (P < .05 for all) but not LH when using the right leg (258 vs 251 ms; P = .82). Controls demonstrated faster TRT than patients with RH (P < .001 for all) but not LH when using the right leg (515 vs 553 ms; P = .44). CONCLUSIONS: When using the nonparetic leg, patients with LH had braking response times comparable to controls, but patients with RH demonstrated significant impairment of both the paretic and nonparetic legs.

Effect of topical anesthetics on needle insertion pain during botulinum toxin type A injections for limb spasticity.

OBJECTIVE: To compare pain perception using 3 anesthetics (eutectic mixture of local anesthetics [EMLA], vapocoolant spray, and ice) compared with a control (no anesthetic) during botulinum toxin type A (BTX-A) injections for lower limb spasticity. DESIGN: A placebo-controlled, single-blinded study where each study patient served as their own control. SETTING: Spasticity clinic. PARTICIPANTS: Subjects (N=30) with ankle spasticity who visited the clinic for BTX-A injections in the gastrocnemius muscle were consecutively sampled. INTERVENTION: The gastrocnemius muscle was divided into 4 quadrants and 1 of the 3 different anesthetic agents was applied to each quadrant with 1 quadrant using no anesthetic, control. MAIN OUTCOME MEASURES: Numerical Rating Scale (NRS) and the Wong-Baker FACES scale. RESULTS: Pain perception using the NRS and FACES scale was significantly lower using ice and EMLA compared with control and spray conditions (P<.05). Pain perception using EMLA and ice was similar. These results indicate that patients experience minimal to moderate pain during BTX-A injections. CONCLUSIONS: Pain relief offered by EMLA and ice was comparable, suggesting that ice is a more convenient option because of brief application time (compared with EMLA). Spray may have made the patients more sensitive to pain and alternative approaches for using vapocoolant should be considered.

Acute neurophysiologic effects of botulinum toxin type A intramuscular injection on extensor digitorum brevis muscle in healthy adults.

INTRODUCTION: Anecdotal clinical experience shows that patients often indicate that their spasticity improves on the day of treatment with intramuscular botulinum injection. Previous research shows that compound motor action potentials (CMAPs) decrease 48 h post-injection. However, no studies to date have assessed the neurophysiological changes less than 48 h post-injection. METHODS: Fifteen healthy control subjects (10 F; mean age 41 ± 11 years) participated in this randomized double-blind study. We injected 10 units of either onabotulinumtoxinA or incobotulinumtoxinA in the extensor digitorum brevis (EDB) muscle, one in each foot. We performed serial CMAP assessments using nerve conduction study of the peroneal nerve at following time intervals after botulinum injection - 2, 4, 6, 24, 26, 28, 30, 48, 72 h and 6 days post-injection. We used an ANOVA with repeated measures separately for each type of toxin. RESULTS: Post-hoc tests using the Bonferroni correction revealed that there was a statistically significant decrease in the mean EDB CMAP amplitude from baseline starting at 24 h post-injection in the incobotulinumtoxinA group (p < 0.05) and 4 h post-injection in the onabotulinumtoxinA group (p < 0.05). CONCLUSION: We conclude that both toxin formulations tested in this study exert a significant decrease in EDB CMAP amplitude in the period of <48 h post-injection.

Feasibility and Safety of a Powered Exoskeleton for Balance Training for People Living with Multiple Sclerosis: A Single-Group Preliminary Study (Rapper III).

OBJECTIVE: To evaluate the feasibility, usability, safety, and potential health benefits of using an exoskeleton device for rehabilitation of people living with multiple sclerosis. DESIGN: Single-group preliminary study. SUBJECTS: Eleven adults living with multiple sclerosis, with Expanded Disability Status Scores that ranged from 6 to 7.5 (mean age (standard deviation; SD) 54.2 (11.8) years), were recruited. METHODS: Individual participants undertook a balance rehabilitation exercise programme using the Rex Rehab robotic exoskeleton device. Each participant undertook 4 × 45-60 min supervised, balance exercise sessions. Primary outcomes were: (i) the number of participants who completed the trial protocol safely, and (ii) the number and nature of adverse events reported. Secondary outcomes were: mobility; balance; spasticity; sleep; functional independence; quality of life; and device satisfaction. RESULTS: Ten out of 11 participants completed the trial protocol safely. Four adverse events were recorded (1 serious), all of which were deemed unrelated to the trial. Secondary outcomes showed allied improvements in balance, joint mobility, spasticity and quality of life. All participants found the device acceptable to use. CONCLUSION: These results suggest that it is feasible and safe to use the Rex Rehab exoskeleton device to assist with balance rehabilitation for people living with multiple sclerosis.

Practice Patterns of Physicians Using Adjunct Therapies with Botulinum Toxin Injection for Spasticity: A Canadian Multicenter Cross-Sectional Survey.

BACKGROUND: Adjunct therapies are nonpharmacological treatments used with botulinum toxin (BoNT) injection that may improve spasticity outcomes. It has been suggested that physicians consider adjunct therapies as a part of comprehensive spasticity management. It is unclear which adjunct therapies are used by physicians in clinical practice. OBJECTIVE: To determine physician practice patterns and perceptions of use of adjunct therapies following BoNT injection for limb spasticity. DESIGN: Cross-sectional national survey of current clinical practice using a 22-item questionnaire developed by the authors. SETTING: Not applicable. PARTICIPANTS: Survey respondents were physicians actively administering BoNT injections for limb spasticity management across Canada (N = 48). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Types of adjunct therapies used by physicians; physician opinions on barriers to adjunct therapy use, patient preferences, and future research priorities. RESULTS: Most physicians prescribe home stretching programs, home active exercise programs, and splinting; however, many physicians perceive that these same adjunct therapies are unwanted by patients. A minority of physicians prescribe electrical stimulation (ES), transcutaneous electrical nerve stimulation (TENS), casting, and extracorporeal shockwave therapy; financial limitations and perceived lack of evidence were identified as barriers to their use. Significantly more physicians practicing in academic settings compared with nonacademic, community, and private practice settings used functional ES (59% vs 11%) and TENS (41% vs 0%) as adjunct therapies (P < .05). Research priorities included determining the effectiveness of immediate postinjection application of adjunct therapies (eg, injected muscle activation with ES or stretching) and nutraceuticals. CONCLUSIONS: Canadian physicians frequently use adjunct therapies in combination with BoNT injection to treat spasticity. Financial and time constraints are identified as barriers to implementation of adjunct therapies that are currently supported by research, and patient preferences may also affect compliance. Future research should focus on adjunct therapies that overcome these barriers.

Reliability of soleus H-reflexes in standing and walking post-incomplete spinal cord injury.

OBJECTIVE: To establish the reliability of soleus H-reflex in individuals with incomplete spinal cord injury (SCI) during the standing and the swing and stance phases of overground walking. METHODS: Fourteen SCI (40 +/- 10 years) and eight noninjured subjects (32 +/- 9 years) participated. The noninjured and SCI subjects walked at self-selected speed overground. H-reflexes in the soleus muscle (at M-wave 7%-13% maximum-M) were tested on two separate days by stimulating the tibial nerve. Intraclass correlation coefficients (two-way mixed model-ICC (1, 2)) and standard error of measurement (SEM) were calculated. RESULTS: Relative reliability of the H-reflexes was good to excellent; intra-class correlation coefficients (ICCs) ranged from 0.64-0.91 in noninjured and SCI subjects. SEM expressed as percentage of the mean H-reflex was 13%-62% in noninjured and 12%-18% in SCI individuals. CONCLUSIONS: H-reflexes can be reliably assessed in standing and walking in post-SCI and noninjured subjects. SIGNIFICANCE: H-reflexes can be reliably used in longitudinal studies to investigate mechanisms of recovery post-SCI.

Soleus H-reflex modulation after motor incomplete spinal cord injury: effects of body position and walking speed.

OBJECTIVE: To examine position-dependent (semireclined to standing) and walking speed-dependent soleus H-reflex modulation after motor incomplete spinal cord injury (SCI). PARTICIPANTS: Twenty-six patients with motor incomplete SCI (mean: 45 +/- 15 years) and 16 noninjured people (mean: 38 +/- 14 years). METHODS: Soleus H-reflexes were evoked by tibial nerve stimulation. Patients were tested in semireclined and standing positions (experiment 1) and in midstance and midswing positions (experiment 2). RESULTS: H-reflexes were significantly greater after SCI in all positions compared with noninjured people (P < 0.05). Position-dependent modulation from semireclined to standing (normally observed in noninjured people) was absent after SCI. In SCI patients, H-reflex modulation was not significantly different at 1.2 m/s compared with 0.6 m/s treadmill walking speed; in noninjured people, H-reflex modulation was significantly greater at 1.2 m/s compared with 0.6 m/s treadmill walking speed. There was a significant positive correlation between modified Ashworth scores, a clinical measure of spasticity and soleus H-reflex amplitudes tested in all positions. A significant negative correlation was also found between H-reflexes in standing and midstance positions and the amount of assistance patients required to walk. CONCLUSIONS: An improvement in position-dependent and walking speed-dependent reflex modulation after SCI may indicate functional recovery. Future studies will use H-reflex testing to track changes as a result of therapeutic interventions.