Adjunct therapies after botulinum toxin injections in spastic adults: Systematic review and SOFMER recommendations

BackgroundAdjunct therapies (ATs) may further improve outcomes after botulinum toxin injections in spastic patients, but evidence was unclear in previous systematic reviews.ObjectiveTo assess the efficacy of non-pharmacological ATs in spastic adults according to the International Classification of Functioning, Disability and Health and build an expert consensus-based on a Delphi process.MethodsFour electronic databases were searched up to May 2020 for reports of comparative trials of non-pharmacologic ATs after botulinum toxin injections in spastic adults. Then, 25 French experts participated in a two-round Delphi process to build recommendations on the use of ATs.ResultsWe included 32 studies (1202 participants, median 32/study) evaluating the effects of physical agents (n = 9), joint posture procedures (JPPs, n = 11), and active ATs (n = 14), mainly after stroke. The average quality of articles was good for randomised controlled trials (median [interquartile range] PEDro score = 7 [6–8]) but moderate (n = 2) or poor (n = 2) for non-randomised controlled trials (Downs & Black checklist). Meta-analysis was precluded owing to the heterogeneity of ATs, control groups and outcome measures. There is evidence for the use of JPPs except low-dose manual stretching and soft posture techniques. Continuous postures (by taping or casting) are recommended; discontinuous postures (by orthosis) may be preferred in patients with active function. Device-free or device-assisted active ATs may be beneficial in the mid-term (> 3 months after botulinum toxin injections), particularly when performed at a high-intensity (> 3 h/week) as in constraint-induced movement therapy. Self-rehabilitation remains understudied after a focal treatment, but its interest is highlighted by the experts. The use of physical agents is not recommended.ConclusionsJPPs and active ATs (device-assisted or device-free) may further improve impairments and activities after botulinum toxin injections. Further studies are needed to better define the best strategies for ATs as a function of the individual treatment goals, participation and quality of life.Review RegistrationPROSPERO (CRD42018105856).     

Guideline for Botulinum Toxin Injections in the Effective Treatment of Fibular Spasticity

This study used a modified Sihler's staining method to analyze the nerve distributions of the fibularis muscle to identify the most effective sites for botulinum toxin injection for fibular spasticity treatment. Ten specimens of the fibularis longus and brevis were obtained bilaterally from five fixed cadavers. The applied method of modified Sihler's staining was designed to reveal the intramuscular nerve distribution of the fibularis muscles. We divided the fibularis muscles into four quarters, which were defined as Sections 1–4 starting from the proximal part of the leg. There were one, two, and three nerve entry points in one (10%), six (60%), and three (30%) of the fibularis longus specimens, respectively, and in four (40%), five (50%), and one (10%) of the fibularis brevis specimens, respectively. We counted the number of nerve endings in each section: 321 and 195 points were identified in the fibularis longus and brevis, respectively. The densities of nerve endings were highest in Section 2 of the fibularis longus (147 of 321, 46%) and in Section 3 of the fibularis brevis (78 of 195, 40%). The landmarks used in this study (the fibular head and lateral malleolus) are easily palpable on the skin's surface, allowing clinicians to target the effective injection site (Section 2) without requiring ultrasound guidance, especially for the fibularis longus. Clin. Anat. 33:365–369, 2020. © 2019 Wiley Periodicals, Inc.     

Acute effects of whole-body vibration on spinal excitability level and ankle plantar flexion spasticity in post-stroke individuals: A randomized controlled trial

IntroductionThis study aimed to evaluate the acute effects (up to 30 min) of whole-body vibration (WBV) on spinal excitability level and ankle plantar flexion spasticity in chronic stroke subjects.MethodsTwenty-one subjects (age 30–70 years old) with chronic stroke and ankle plantar flexion spasticity were randomly assigned to the vibration group (VG, n = 11) or the control group (CG, n = 10). Subjects in the VG underwent 10 minutes of WBV with a frequency of 35 Hz and amplitude of 2 mm. Subjects in the CG remained on the platform for 10 min without receiving vibratory stimulus. The spinal excitability level was estimated by the Hmax/Mmax ratio extracted from the H-reflex with simple stimulus examination. The value of the second/first wave ratio (H2/H1 ratio) at the peak of the first facilitation was also considered through the recovery curve with double stimulation. Spasticity was estimated by the Modified Ashworth Scale (MAS) and global perception of change. All outcomes were assessed before and at 10, 20, and 30 min after the WBV, except for MAS, which was evaluated only 10 min after WBV.ResultsNo between-group differences were found in either the spinal excitability level or plantar flexor spasticity at the three evaluated moments after WBV.ConclusionThese results suggest that WBV does not reduce spinal excitability level or spasticity of the plantar flexor muscles in chronic stroke patients in the first 30 min after vibratory stimulus.     

A review and evaluation of patient-reported outcome measures for spasticity in persons with spinal cord damage: Recommendations from the Ability Network – an international initiative

Context: Patient-reported outcome measures (PROMs) are valuable for capturing the impact of spasticity on health-related quality of life (HRQoL) in persons with spinal cord damage (SCD) and evaluating the efficacy of interventions.Objective: To provide practical guidance for measuring HRQoL in persons with spasticity following SCD.Methods: Literature reviews identified measures of HRQoL and caregiver burden, utilized in studies addressing spasticity in SCD. Identified measures were evaluated for clinical relevance and practicality for use in clinical practice and research. The PRISM, SCI-SET, EQ-5D and SF-36 instruments were mapped to the International Classification of Functioning, Disability and Health (ICF). The PRISM and SCI-SET were evaluated using the Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) checklist.Results: Two spasticity-specific, five generic, and four preference-based measures were identified. ICF mapping and the COSMIN checklist supported the use of the PRISM and SCI-SET in SCD. The SF-36 is considered the most useful generic measure; disability-adapted versions may be more acceptable but further studies on psychometric properties are required. The SF-36 can be converted to a preference-based measure (SF-6D), or alternatively the EQ-5D can be used. While no measures specific to caregivers of people with SCD were identified, the Caregiver Burden Scale and the Zarit Burden Interview are considered suitable.Conclusion: Recommended measures include the PRISM and SCI-SET (condition-specific), SF-36 (generic), and Caregiver Burden Scale and Zarit Burden Interview (caregiver burden). Consideration should be given to using condition-specific and generic measures in combination; the PRISM or SCI-SET combined with SF-36 is recommended.     

Design,characterisation and evaluation of a soft robotic sock device on healthy subjects for assisted ankle rehabilitation

Motor impairment is one of the common neurological conditions suffered by stroke patients, where this chronic immobility together with the absence of early limb mobilisation can lead to conditions such as joint contracture with spastic limbs. In this study, a soft robotic sock device was developed, which can provide compliant actuation to the ankle joint in the early stage of stroke recovery. The device is fitted with soft extension actuators and when the actuators are inflated, they extend and guide the foot into plantarflexion; upon deflation, the actuators will resume their initial conformations. Each actuator is linked to a pneumatic pump-valve control system that injects pressurised air into or release air from the system. In this study, the design and characterisation of the soft actuators will be presented, where the theoretical and experimental forces generated by the actuators were compared. The performance of the device was also evaluated on healthy subjects and the results had shown that the device was able to move the subjects’ ankles into cycles of dorsiflexion-plantarflexion, in the absence of voluntary muscle effort. The findings suggested that the soft wearable robotic device was capable of assisting the subjects in performing repeated cycles of ankle flexion.     

Acupuncture for upper-extremity rehabilitation in chronic stroke: a randomized sham-controlled study

OBJECTIVE: To compare the effects of traditional Chinese acupuncture with sham acupuncture on upper-extremity (UE) function and quality of life (QOL) in patients with chronic hemiparesis from stroke. DESIGN: A prospective, sham-controlled, randomized controlled trial (RCT). SETTING: Patients recruited through a hospital stroke rehabilitation program. PARTICIPANTS: Thirty-three subjects who incurred a stroke 0.8 to 24 years previously and had moderate to severe UE functional impairment. INTERVENTIONS: Active acupuncture tailored to traditional Chinese medicine diagnoses, including electroacupuncture, or sham acupuncture. Up to 20 treatment sessions (mean, 16.9) over a mean of 10.5 weeks. MAIN OUTCOME MEASURES: UE motor function, spasticity, grip strength, range of motion (ROM), activities of daily living, QOL, and mood. All outcomes were measured at baseline and after treatment. RESULTS: Intention-to-treat (ITT) analyses found no statistically significant differences in outcomes between active and sham acupuncture groups. Analyses of protocol-compliant subjects revealed significant improvement in wrist spasticity (P<.01) and both wrist (P<.01) and shoulder (P<.01) ROM in the active acupuncture group, and improvement trends in UE motor function (P=.09) and digit ROM (P=.06). CONCLUSIONS: Based on ITT analyses, we conclude that acupuncture does not improve UE function or QOL in patients with chronic stroke symptoms. However, gains in UE function observed in protocol-compliant subjects suggest traditional Chinese acupuncture may help patients with chronic stroke symptoms. These results must be interpreted cautiously because of small sample sizes and multiple, unadjusted, post hoc comparisons. A larger, more definitive RCT using a similar design is feasible and warranted.     

Neurophysiological methods for the assessment of spasticity: The Hoffmann reflex, the tendon reflex, and the stretch reflex

Purpose: To review the literature concerning neurophysiological methods to assess spasticity with respect to mechanisms and methodology, and to describe the three most commonly used methods: the Hoffmann reflex (H-reflex), the Tendon reflex (T-reflex), and the Stretch Reflex (SR). Method: A systematic internet database search was performed to identify neurophysiological measurement methods of spasticity. A systematic exclusion procedure resulted in 185 included references, completed by additional informal search. For this paper, information about the H-, T- and stretch reflexes was extracted from these references. Results: Although the reflexes are basically monosynaptic, there are many supraspinal pathways which modulate the responses in terms of their amplitude and latency. As a consequence the methods are sensitive to a considerable number of experimental conditions and are characterized by a moderate reliability and sensitivity. Correlations with other (i.e. biomechanical, neurophysiological or clinical) spasticity assessment parameters are moderate to poor. Standardised and broadly accepted protocols are still largely lacking preventing an effective exchange of knowledge. Conclusions: The clinical and experimental use of the three methods is restricted due to moderate reliability and sensitivity. It is recommended to perform combined neurophysiological - biomechanical assessment of spasticity during active, functional movement.     

非肌电引导下A型肉毒毒素注射治疗儿童痉挛型脑瘫的疗效观察

目的：探讨非肌电引导下A型肉毒毒素注射治疗儿童痉挛型脑瘫的疗效.方法：选择68例双下肢痉挛型脑瘫患儿,采用＂反向牵拉指压法＂进行非肌电引导下定点后多点注射治疗,注射后次日开始进行痉挛肌牵伸及功能训练,注射后1周配戴AFO或KAFO,并强化康复训练.注射前及注射后3天、1周、1个月、2个月、3个月听取父母的报告,观察内收肌角、直腿抬高角、腘窝角、踝背伸角,痉挛肌改良Ashworth分级及粗大运动评分的变化.结果：①父母的报告：起效时间为注射后6-72h,到达高峰时间为1-2周,疗效维持＞3月,有少数患儿1-2个月后疗效开始减弱.痉挛严重,注射剂量＞24U/kg体重的10例患儿,于注射后24h出现无力、食欲减退等副反应,并在3周至1个月消失;②内收肌角、直腿抬高角、腘窝角、踝背伸角自注射后3天开始显著增大（P＜0.05）,1个月时达高峰（P＜0.001）,至3个月后又有变小,但并未回复到注射前;③痉挛肌改良Ashworth分级与关节活动度的变化规律一致;④粗大运动评分（GMFM-66）1个月后显著改善（P＜0.05）,并在随后的观察中持续性改善;⑤疗效及副反应与剂量呈显著相关.结论：A型肉毒毒素注射配合矫形器及康复训练,能有效改善痉挛性脑瘫患儿的运动功能,非肌电引导的徒手定位注射技术经济、便捷、有效,多点注射技术有可能减少由于高剂量带来的远处副作用及非靶肌的扩散.     

Évaluation médico-économique du baclofène intrathécal chez les patients présentant une spasticité chronique sévère

A medicoeconomic evaluation of continuous intrathecal baclofen (Lioresal^®) infusion for symptomatic treatment of severe spinal spasticity was realised using a monocentric, comparative, retrospective approach where subjects were their own controls (n = 22). Study results confirm the efficacy of baclofen on symptoms, functional status of patients and on a non specific quality of life scale. Conversely, use of baclofen lead to a 67% increase of average annual costs of care for these patients and reaches around 173,500 French francs (~29,000 US$)/year. Such a cost seems to be acceptable with respect to clinical benefits. © 1998 Elsevier, Paris