What is the clinical effect and cost effectiveness of treating upper limb spasticity due to stroke with botulinum toxin?

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 332

Inclusion Criteria

• Aged over 18 years
• At least 1 month since stroke
• Upper limb spasticity ( MAS >2 at the elbow and/or spasticity at wrist or shoulder (no validated measure of spasticity at these sites.)
• Reduced UL function (ARAT score 0-56).
• Willing and able to participate in UL therapy programme.
• Patient must be able and willing to understand and comply with the requirements of the protocol and the UL therapy programme.
•Written informed consent before completing any study-related procedure (any assessment or evaluation that would not have formed par of their normal care). Patient must be able and willing to understand and comply with the requirements of the protocol and the UL therapy programme.

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 speech or cognitive impairment which will impede assessment
•Other significant upper limb impairment e.g. fracture or frozen shoulder within 6 months, severe arthritis, amputation.
•Evidence of contracture
•Pregnancy or lactation (female patients who are at risk of pregnancy must have a negative pregnancy test on the day of randomisation and prior to any subsequent botulinum injection).
•Female patients at risk of pregnancy who are not willing to take adequate precautions against pregnancy for the duration of the study.
•Diagnosis likely to interfere with rehabilitation or outcome assessments e.g. registered blind, malignancy.
•Other diagnosis which may contribute to upper limb spasticity e.g. multiple sclerosis, cerebral palsy.
•Contraindications to intramuscular injection.
•Religious objections to blood products(botulinum toxin contains human albumin)
•Contraindications to botulinum toxin which include bleeding disorders, myasthenia gravis and concurrent use of aminoglycosides.
•Use of botulinum toxin to the upper limb in the previous three months.
•Known allergy or hypersensivity to any of the test compounds

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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