Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2022 Apr 25;22(1):154.
doi: 10.1186/s12883-022-02672-8.

Long-term effect of additional rehabilitation following botulinum toxin-A on upper limb activity in chronic stroke: the InTENSE randomised trial

Natasha A Lannin  1   2   3 , Louise Ada  4 , Coralie English  5 , Julie Ratcliffe  6 , Steven Faux  7   8 , Mithu Palit  9 , Senen Gonzalez  10 , John Olver  11 , Emma Schneider  12   9 , Maria Crotty  6   13 , Ian D Cameron  14
Affiliations
Randomized Controlled Trial

Long-term effect of additional rehabilitation following botulinum toxin-A on upper limb activity in chronic stroke: the InTENSE randomised trial

Natasha A Lannin et al. BMC Neurol. .

Abstract

Background: It is common for people with persistent spasticity due to a stroke to receive an injection of botulinum toxin-A in the upper limb, however post-injection intervention varies.

Aim: To determine the long-term effect of additional upper limb rehabilitation following botulinum toxin-A in chronic stroke.

Method: An analysis of long-term outcomes from national, multicenter, Phase III randomised trial with concealed allocation, blinded measurement and intention-to-treat analysis was carried out. Participants were 140 stroke survivors who were scheduled to receive botulinum toxin-A in any muscle(s) that cross the wrist because of moderate to severe spasticity after a stroke greater than 3 months ago, who had completed formal rehabilitation and had no significant cognitive impairment. Experimental group received botulinum toxin-A plus 3 months of evidence-based movement training while the control group received botulinum toxin-A plus a handout of exercises. Primary outcomes were goal attainment (Goal Attainment Scale) and upper limb activity (Box and Block Test) at 12 months (ie, 9 months beyond the intervention). Secondary outcomes were spasticity, range of motion, strength, pain, burden of care, and health-related quality of life.

Results: By 12 months, the experimental group scored the same as the control group on the Goal Attainment Scale (MD 0 T-score, 95% CI -5 to 5) and on the Box and Block Test (MD 0.01 blocks/s, 95% CI -0.01 to 0.03). There were no differences between groups on any secondary outcome.

Conclusion: Additional intensive upper limb rehabilitation following botulinum toxin-A in chronic stroke survivors with a disabled upper limb is not more effective in the long-term.

Trial registration: ACTRN12615000616572 (12/06/2015).

Keywords: Botulinum toxin type A; Neuroscience; Rehabilitation; Spasticity; Stroke; Wrist.

PubMed Disclaimer

Conflict of interest statement

J Olver and S Gonzalez declare that they have received honoraria from Allergan; J Olver, M Palit and S Gonzalez declare that they have received honoraria from Ipsen; S Gonzalez declares that he has received honoraria from Merz. The other authors report no conflicts.

Figures

Fig. 1
Fig. 1
Design of and flow of participants through the study
See this image and copyright information in PMC

References

    1. Cardoso E, Rodrigues B, Lucena R, de Oliveira IR, Pedreira G, Melo A. Botulinum Toxin Type A for the Treatment of the Upper Limb Spasticity After Stroke. Arq Neuropsiquiatr. 2005;63:30–33. doi: 10.1590/S0004-282X2005000100006. - DOI - PubMed
    1. Mills PB, Finlayson H, Sudol M, O’Connor R. Systematic review of adjunct therapies to improve outcomes following botulinum toxin injection for treatment of limb spasticity. Clin Rehabil. 2016;30(6):537–548. doi: 10.1177/0269215515593783. - DOI - PubMed
    1. Kinnear BZ, Lannin NA, Cusick A, Harvey LA, Rawicki B. Rehabilitation therapies after botulinum toxin-A injection to manage limb spasticity: a systematic review. Phys Ther. 2014;94(11):1569–1581. doi: 10.2522/ptj.20130408. - DOI - PubMed
    1. Kwakkel G, Kollen B. Predicting improvement in the upper paretic limb after stroke: a longitudinal prospective study. Restor Neurol Neurosci. 2007;25(5–6):453–460. - PubMed
    1. Cusick A, Lannin, N.A., Kinnear, B. Upper limb spasticity management for patients who have received Botulinum Toxin A injection: Australian therapy practice. Aust Occup Ther J. 2014. - PubMed

Publication types

Substances