Stroke.Spasticity.
Conditions
Interventions
Trade Name: Botox 100 units
Product Name: Botox
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: protein complex derived from
Sponsors
SWBH NHS Trust
Keele University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Over 18 years of age. • Patients with stroke due to a primary cerebral haemorrhage/infarction, subarachnoid haemorrhage producing an upper motor syndrome affecting one body side which results in a hemiplegia. • Capable of providing informed consent directly or indirectly, or, consent obtainable from next of kin or legal representative. • No useful arm function (i.e. less than or equal to 2 on the grasp subsection of the Action Research Arm Test) at onset of spasticity. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Significant musculoskeletal conditions that affected upper limb function prior to the stroke. • Unconscious or moribund during the screening period. • Recovery of useful arm function (a score of 3 or more in the grasp section of the Action Research Arm Test) prior to injections. • Patients with contraindications to electrical stimulation including active implants (e.g. cardiac assist devices), metal implants at site of stimulation, scar tissue/cancerous tissue at site of stimulation, uncontrolled epilepsy, deep vein thrombosis in limb / muscle being stimulated and pregnancy (or planned pregnancy). • Previous Upper motor neurone syndrome or hypertonicity due to multiple sclerosis, spinal cord injury or other neurological disorder. • Patients with a known hypersensitivity to any botulinum toxin or to any of the excipients of BOTOX® (i.e. Human serum albumin) • Patients with myasthenia gravis or Eaton Lambert Syndrome or other neuromuscular junction or myopathic disorder • Patients with infection at the proposed injection site(s) • Patients who are pregnant or may become pregnant at the time of the proposed injections and for the duration of the study. • Current treatment with any anti-spasticity agent or previous injection with BOTOX
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Arm function measured using the Action Research Arm Test at 3 months post injection and 6 months post stroke.;Main Objective: Is treating spasticity using a combination of BoNTA and standardised physiotherapy, as soon as signs of abnormal muscle activity are observed, more effective in facilitating the recovery of arm function following stroke than standardised physiotherapy alone?;Secondary Objective: Is treating spasticity using a combination of BoNTA and standardised physiotherapy, as soon as signs of abnormal muscle activity are observed, more effective in preventing secondary complications of stiffness, contractures and pain than standardised physiotherapy alone? Does such treatment also reduce burden of care and improve quality of life compared to standardised physiotherapy alone? Is the early detection and treatment of upper limb spasticity with BoNTA and standardised physiotherapy more cost effective than standardised physiotherapy alone? | — |
Countries
United Kingdom
Outcome results
None listed