Abstract
Background
Improved walking is one of the highest priorities in people living with stroke. Post-stroke lower limb spasticity (PSLLS) impedes walking and quality of life (QOL). The understanding of the evidence of improved walking and QOL following botulinum toxin (BoNTA) injection is not clear. We performed a systematic review of the randomized control trials (RCT) to evaluate the effectiveness of BoNTA injection on walking and QOL in PSLLS.
Methods
We searched PubMed, Web of Science, Embase, CINAHL, ProQuest Thesis and Dissertation checks, Google Scholar, WHO International Clinical Trial Registry Platform, ClinicalTrials.gov, Cochrane, and ANZ and EU Clinical Trials Register for RCTs looking at improvement in walking and QOL following injection of BoNTA in PSLLS. The original search was carried out prior to 16 September 2015. We conducted an additional verifying search on CINHAL, EMBASE, and MEDLINE (via PubMed) from 16 September 2015 to 6 June 2017 using the same clauses as the previous search. Methodological quality of the individual studies was critically appraised using Joanna Briggs Institute’s instrument. Only placebo-controlled RCTs looking at improvement in walking and QOL were included in the review.
Results
Of 2026 records, we found 107 full-text records. Amongst them, we found five RCTs qualifying our criteria. No new trials were found from the verifying search. Two independent reviewers assessed methodological validity prior to inclusion in the review using Joanna Briggs Institute’s appraisal instrument. Two studies reported significant improvement in gait velocity (p = 0.020) and < 0.05, respectively. One study showed significant improvement in 2-min-walking distance (p < 0.05). QOL was recorded in one study without any significant improvement. Meta-analysis of reviewed studies could not be performed because of different methods of assessing walking ability, small sample size with large confidence interval and issues such as lack of power calculations in some studies. Findings from our systematic and detailed study identify the need for a well-designed RCT to adequately investigate the issues highlighted.
Conclusions
This review could not conclude there was sufficient evidence to support or refute improvement on walking or QOL following BoNTA injection. Reasons for this are discussed, and methods for future RCTs are developed.
Background
Stroke is a common cause of adult disability worldwide [1]. More than two thirds of the stroke survivors develop post-stroke sequelae including impaired motor functions and spasticity [2]. The prevalence of post-stroke spasticity ranges from 19.0 to 42.6% [3]. There have been many recent developments in diagnosis, management, and prevention of stroke, while advances in rehabilitation have been modest [4]. There has, however, been progress with the use of botulinum toxin (BoNTA) as a treatment to improve spasticity in the upper limb [5, 6, 7]. Three systematic reviews [8, 9, 10] have addressed research progress on both the upper and lower limbs, with the conclusion from two of these that the effect on the upper and lower limbs spasticity favored BoNTA [8, 9]; however, these reviews did not fulfill the criteria for inclusion in this study.
As far as the lower limb is concerned, improvement in spasticity while important is only a first stage in post-stroke improvement, and the aim of RCTs should be to address the more important questions of functional activity including walking. How well this outcome has been addressed is the aim of this study. This is also an important question for many countries to resolve, because to date, botulinum toxin A is not approved for use in the post-stroke lower limb spasticity (PSLLS) by the pharmaceutical authorities except in the USA [11].
Lower limb spasticity most commonly involves the foot and the ankle leading to equinovarus (plantarflexion and inversion) deformity. Post-stroke patients with equinovarus deformity fail to achieve optimal contact with the ground leading to a poor stance, loss of heel to toe rhythm while walking and post-stroke patients walk predominantly with plantarflexion/inversion of the foot. Transfers and walking are essentially bipedal activity involving phases like balancing on one leg and swinging the other leg forward. The awkward position of the foot in addition to spasticity impairs balance, transfer, stride, gait, and mobility, besides causing spasm and pain. In many cases, complications like falls, fractures, deep vein thrombosis, and pressure ulcers may also result [12]. Inability to walk is associated with loss of independence and premature residential aged care placement [13, 14] and in the older population contributes substantially to adverse health outcomes including activities of daily living and mortality [15]. Improving and maintaining walking ability and activities of daily living are therefore vital for post-stroke survivors [16] and a major contributor to functional improvements. The overall human and economic cost of spasticity is, therefore, considerable, and interventions potentially can deliver significant benefits [17].
Given the evidence for efficacy of BoNTA in reducing spasticity, the objective of this review was to assess the available evidence of BoNTA injection: (1) to improve mobility (using gait velocity and walking distance as measuring parameters) and quality of life (QOL) and (2) to make appropriate recommendations for further research regarding these questions. […]
TBI Rehabilitation 