The early use of botulinum toxin in post-stroke spasticity: study protocol for a
randomised controlled trial.
Author(s): Lindsay C(1), Simpson J, Ispoglou S, Sturman SG, Pandyan AD.
Affiliation(s): Author information:
(1)Physiotherapy Department, Sandwell and West Birmingham NHS Trust and School of
Health and Rehabilitation, Keele University, Mackay Building, Keele,
Staffordshire ST5 5BG, UK. Camlin3@hotmail.com.
Publication date & source: 2014, Trials. , 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.
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