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The early use of botulinum toxin in post-stroke spasticity: study protocol for a randomised controlled trial.

Lindsay, C., Simpson, J., Ispoglou, S., Sturman, S. G. and Pandyan, A. D, 2014. The early use of botulinum toxin in post-stroke spasticity: study protocol for a randomised controlled trial. Trials, 15, 12.

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The early use of botulinum toxin in post-stroke spasticity study protocol for a randomised controlled trial.pdf - Published Version


DOI: 10.1186/1745-6215-15-12


BACKGROUND: Patients surviving stroke but who have significant impairment of function in the affected arm are at more risk of developing pain, stiffness and contractures. The abnormal muscle activity, associated with post-stroke spasticity, is thought to be causally associated with the development of these complications. Treatment of spasticity is currently delayed until a patient develops signs of these complications. METHODS/DESIGN: This protocol is for a phase II study that aims to identify whether using OnabotulinumtoxinA (BoNT-A) in combination with physiotherapy early post stroke when initial abnormal muscle activity is neurophysiologically identified can prevent loss of range at joints and improve functional outcomes.The trial uses a screening phase to identify which people are appropriate to be included in a double blind randomised placebo-controlled trial. All patients admitted to Sandwell and West Birmingham NHS Trust Hospitals with a diagnosis of stroke will be screened to identify functional activity in the arm. Those who have no function will be appropriate for further screening. Patients who are screened and have abnormal muscle activity identified on EMG will be given electrical stimulation to forearm extensors for 3 months and randomised to have either injections of BoNT-A or normal saline. The primary outcome measure is the action research arm test - a measure of arm function. Further measures include spasticity, stiffness, muscle strength and fatigue as well as measures of quality of life, participation and caregiver strain. TRIAL REGISTRATIONS: ISRCTN57435427, EudraCT2010-021257-39, NCT01882556.

Item Type:Article
Additional Information:This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver ( applies to the data made available in this article, unless otherwise stated.
Uncontrolled Keywords:Biomechanical Phenomena; Botulinum Toxins, Type A; Clinical Protocols; Double-Blind Method; England; Humans; Muscle Spasticity; Muscle, Skeletal; Neuromuscular Agents; Physical Therapy Modalities; Range of Motion, Articular; Research Design; Stroke; Time Factors; Treatment Outcome
Group:Faculty of Health & Social Sciences
ID Code:36619
Deposited By: Symplectic RT2
Deposited On:16 Feb 2022 15:29
Last Modified:14 Mar 2022 14:32


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