Abstract
Background
Botulinum toxin-A is provided for adults with post-stroke spasticity. Following injection, there is a variation in the rehabilitation therapy type and amount provided. The purpose of this study was to determine if it is feasible to add intensive therapy to botulinum toxin-A injections for adults with spasticity and whether it is likely to be beneficial.
Methods
Randomized trial with concealed allocation, assessor blinding, and intention to treat analysis. Thirty-seven adults (n = 3 incomplete or lost follow-up) with spasticity in the upper or lower limb were allocated to one of three groups: experimental group received a single dose of botulinum toxin-A plus an intensive therapy for 8 weeks, control group 1 received a single dose of botulinum toxin-A only, and control group 2 received intensive therapy only for 8 weeks. Feasibility was measured by examining recruitment, intervention (adherence, acceptability, safety), and measurement. Benefit was measured as goal achievement (Goal Attainment Scale), upper limb activity (Box and Block Test), walking (6-min walk test) and spasticity (Tardieu scale), at baseline (week 0), immediately after (week 8), and at three months (week 12).
Results
Overall recruitment fraction for the trial was 37% (eligibility fraction 39%, enrolment fraction 95%). The 26 participants allocated to receive intensive rehabilitation attended 97% of clinic-based sessions (mean 11 ± 2 h) and an averaged 58% (mean 52 ± 32 h) of prescribed 90 h of independent practice. There were no study-related adverse events reported. Although participants in all groups increased their goal attainment, there were no between-group differences for this or other outcomes at week 8 or 12.
Conclusion
Providing intensive therapy following botulinum toxin-A is feasible for adults with neurological spasticity. The study methods are appropriate for a future trial. A future trial would require 134 participants to detect a between-group difference of 7 points on Goal Attainment Scale t-scores with an alpha of 0.05 and power of 80%.
Background
Spasticity affects approximately 20% of stroke survivors [1–4] and is thought to significantly contribute to falls after stroke [5, 6] as well as decreased activity participation [3, 4]. Unsurprisingly, higher costs are thus incurred by patients with spasticity during the first year of survival [7]. Health professionals identify that addressing spasticity is a high priority during rehabilitation [8], and there is international consensus that localized spasticity (i.e., in the upper or lower limbs) is best managed with a combination of botulinum toxin and physical therapy [9, 10]. While these consensus papers appear to agree, clinical management remains diverse [11, 12] and provides an ongoing challenge for both therapists and health services alike.
In Australia, stroke rehabilitation is guided by the Stroke Foundation clinical practice guidelines [13]. These guidelines recommend that management of moderate to severe spasticity include the use of botulinum toxin type A in additionto physical therapy interventions [13]. Unfortunately, clinical survey data suggests that occupational therapists and physiotherapists report providing therapy post-botulinum toxin type A injections less than a quarter of the time (an estimated 16%) [12]. This low rate of therapy provision suggests ongoing uncertainty among clinicians as to how to treat patients with spasticity. Such uncertainty is likely to stem from the lack of research studies that describe the type, frequency, intensity, and duration of therapy that is effective for people who have received botulinum toxin injections. While there are previous studies which have tested the efficacy of botulinum toxin type A for spasticity management after stroke [14–16], what remains unknown is whether or not therapy should be provided to this group of patients.
To inform best practice in the treatment and rehabilitation of spasticity in people with neurological conditions, understanding whether the suggested combined effects of using both therapy and botulinum toxin type A together is more beneficial than botulinum toxin-A alone or physiotherapy interventions alone is key. Given the lack of research in this area, a large, powered randomized controlled trial is required. In preparation for this trial, it is key to understand both the feasibility and likely effects of the interventions; therefore, the research questions posed in this pilot study were:
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In neurological patients with spasticity, is it feasible to add intensive therapy to botulinum toxin-A injections if the therapy includes both clinic-based and home-based therapy sessions?
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Is adding intensive therapy likely to be of any benefit to goal attainment, upper limb activity, walking, and spasticity over botulinum toxin-A alone or intensive therapy alone?[…]
TBI Rehabilitation 