Is it clinically effective to treat arm flexor spasticity, with Botulinum toxin – type A (BoNTA) and physiotherapy, as soon as signs of abnormal muscle activity are observed? (A phase II study) - Using BoNTA and physiotherapy to manage spasticity in acute stroke

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 93

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

• 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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