Demetrios Marina, Khan Fary, Turner-Stokes Lynne, Brand Caroline, McSweeney Shane
Department of Rehabilitation Medicine, Royal Melbourne Hospital, Royal Park Campus, Melbourne, Australia.
Cochrane Database Syst Rev. 2013 Jun 5;2013(6):CD009689. doi: 10.1002/14651858.CD009689.pub2.
Spasticity may affect stroke survivors by contributing to activity limitations, caregiver burden, pain and reduced quality of life (QoL). Spasticity management guidelines recommend multidisciplinary (MD) rehabilitation programmes following botulinum toxin (BoNT) treatment for post-stroke spasticity. However, the evidence base for the effectiveness of MD rehabilitation is unclear.
To assess the effectiveness of MD rehabilitation, following BoNT and other focal intramuscular treatments such as phenol, in improving activity limitations and other outcomes in adults and children with post-stroke spasticity. To explore what settings, types and intensities of rehabilitation programmes are effective.
We searched the Cochrane Stroke Group Trials Register (February 2012), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 12), MEDLINE (1948 to December 2011), EMBASE (1980 to January 2012), CINAHL (1982 to January 2012), AMED (1985 to January 2012), LILACS (1982 to September 2012), PEDro, REHABDATA and OpenGrey (September 2012). In an effort to identify further published, unpublished and ongoing trials we searched trials registries and reference lists, handsearched journals and contacted authors.
We included randomised controlled trials (RCTs) that compared MD rehabilitation (delivered by two or more disciplines in conjunction with medical input) following BoNT and other focal intramuscular treatments for post-stroke spasticity with placebo, routinely available local services, or lower levels of intervention; or studies that compared MD rehabilitation in different settings, of different types, or at different levels of intensity. We excluded RCTs that assessed the effectiveness of unidisciplinary therapy (for example physiotherapy only) or a single modality (for example stretching, casting, electrical stimulation or splinting only). The primary outcomes were validated measures of activity level (active and passive function) according to the World Health Organization's International Classification of Functioning, Disability and Health. Secondary outcomes included measures of symptoms, impairments, participation, QoL, impact on caregivers and adverse events.
We independently selected the trials, extracted data, and assessed methodological quality using the Grades of Recommendation, Assessment, Development and Evaluation (GRADE). Due to the limited number of included studies, with clinical, methodological and statistical heterogeneity, quantitative meta-analysis was not possible. Therefore, GRADE provided qualitative synthesis of 'best evidence'.
We included three RCTs involving 91 participants. All three studies scored 'low quality' on the methodological quality assessment, implying high risk of bias. All studies investigated various types and intensities of outpatient rehabilitation programmes following BoNT for upper limb spasticity in adults with chronic stroke. Rehabilitation programmes included: modified constraint-induced movement therapy (mCIMT) compared with a neurodevelopmental therapy programme; task practice therapy with cyclic functional electrical stimulation (FES) compared with task practice therapy only; and occupational, manual therapy with dynamic elbow extension splinting compared with occupational therapy only. There was 'low quality' evidence for mCIMT improving upper limb motor function and spasticity in chronic stroke survivors with residual voluntary upper limb activity, up to six months, and 'very low quality' evidence for dynamic elbow splinting and occupational therapy reducing elbow range of movement at 14 weeks. Task practice therapy with cyclic FES did not improve upper limb function more than task practice therapy alone, only at 12 weeks. No studies addressed interventions in children and those with lower limb spasticity, or after other focal intramuscular treatments for spasticity.
AUTHORS' CONCLUSIONS: At best there was 'low level' evidence for the effectiveness of outpatient MD rehabilitation in improving active function and impairments following BoNT for upper limb spasticity in adults with chronic stroke. No trials explored the effect of MD rehabilitation on 'passive function' (caring for the affected limb), caregiver burden, or the individual's priority goals for treatment. The optimal types (modalities, therapy approaches, settings) and intensities of therapy for improving activity (active and passive function) in adults and children with post-stroke spasticity, in the short and longer term, are unclear. Further research is required to build evidence in this area.
痉挛可能会导致活动受限、照护者负担加重、疼痛以及生活质量(QoL)下降,从而影响中风幸存者。痉挛管理指南建议在肉毒杆菌毒素(BoNT)治疗中风后痉挛后采用多学科(MD)康复计划。然而,MD康复有效性的证据基础尚不清楚。
评估MD康复(在BoNT及其他局部肌肉注射治疗如苯酚之后进行)对改善成人和儿童中风后痉挛患者的活动受限及其他结局的有效性。探讨何种康复计划的设置、类型和强度是有效的。
我们检索了Cochrane中风小组试验注册库(2012年2月)、Cochrane对照试验中央注册库(CENTRAL)(Cochrane图书馆2011年第12期)、MEDLINE(1948年至2011年12月)、EMBASE(1980年至2012年1月)、CINAHL(1982年至2012年1月)、AMED(1985年至2012年1月)、LILACS(1982年至2012年9月)、PEDro、REHABDATA和OpenGrey(2012年9月)。为了识别更多已发表、未发表及正在进行的试验,我们检索了试验注册库和参考文献列表,手工检索了期刊并联系了作者。
我们纳入了随机对照试验(RCT),这些试验比较了BoNT及其他局部肌肉注射治疗中风后痉挛后采用的MD康复(由两个或更多学科结合医学投入实施)与安慰剂、常规可得的当地服务或较低水平的干预;或比较了不同设置、不同类型或不同强度水平的MD康复的研究。我们排除了评估单学科治疗(例如仅物理治疗)或单一模式(例如仅拉伸、支具固定、电刺激或夹板固定)有效性的RCT。主要结局是根据世界卫生组织的《国际功能、残疾和健康分类》对活动水平(主动和被动功能)进行的有效测量。次要结局包括症状、损伤、参与度、生活质量、对照护者的影响及不良事件的测量。
我们独立选择试验、提取数据,并使用推荐分级、评估、制定与评价(GRADE)方法评估方法学质量。由于纳入研究数量有限,存在临床、方法学和统计学异质性,无法进行定量荟萃分析。因此,GRADE提供了“最佳证据”的定性综合。
我们纳入了3项涉及91名参与者的RCT。所有三项研究在方法学质量评估中均得“低质量”,这意味着存在高偏倚风险。所有研究均调查了BoNT治疗慢性中风成人上肢痉挛后门诊康复计划的各种类型和强度。康复计划包括:改良强制性运动疗法(mCIMT)与神经发育疗法计划相比;任务实践疗法结合周期性功能性电刺激(FES)与仅任务实践疗法相比;职业、手法治疗结合动态伸肘夹板固定与仅职业治疗相比。有“低质量”证据表明mCIMT可改善有残余上肢自主活动的慢性中风幸存者的上肢运动功能和痉挛,长达6个月,以及有“极低质量”证据表明动态肘部夹板固定和职业治疗在14周时会减少肘部活动范围。结合周期性FES的任务实践疗法并不比仅任务实践疗法更能改善上肢功能,仅在12周时如此。没有研究涉及儿童及下肢痉挛患者的干预措施,或其他局部肌肉注射治疗痉挛后的情况。
充其量只有“低水平”证据表明门诊MD康复对改善慢性中风成人上肢痉挛患者在接受BoNT治疗后的主动功能和损伤有效。没有试验探讨MD康复对“被动功能”(照顾患肢)、照护者负担或个体治疗优先目标的影响。目前尚不清楚在短期和长期内,改善中风后痉挛成人和儿童活动(主动和被动功能)的最佳治疗类型(模式、治疗方法、设置)和强度。该领域需要进一步研究以积累证据。