24401159
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 .
BACKGROUND	The abnormal muscle activity , associated with post-stroke spasticity , is thought to be causally associated with the development of these complications .
BACKGROUND	Treatment of spasticity is currently delayed until a patient develops signs of these complications .
METHODS	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 .
METHODS	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 .
METHODS	Those who have no function will be appropriate for further screening .
METHODS	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 .
METHODS	The primary outcome measure is the action research arm test - a measure of arm function .
METHODS	Further measures include spasticity , stiffness , muscle strength and fatigue as well as measures of quality of life , participation and caregiver strain .
BACKGROUND	ISRCTN57435427 , EudraCT2010-021257-39 , NCT01882556 .

