ISRCTN78533119
Completed
Not Applicable
What is the clinical effect and cost effectiveness of treating upper limb spasticity due to stroke with botulinum toxin?
The Newcastle Upon Tyne Hospitals NHS Foundation Trust (UK)0 sites390 target enrollmentAugust 6, 2004
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- pper limb spasticity due to stroke
- Sponsor
- The Newcastle Upon Tyne Hospitals NHS Foundation Trust (UK)
- Enrollment
- 390
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age over 18 years
- •2\. At least 1 month since stroke
- •3\. Upper limb (UL) spasticity (modified Ashworth scale \>2 at the elbow and/or spasticity at wrist or shoulder
- •4\. Reduced UL function but with some general function retained (Action Research Arm Test \[ARAT] score 4\-56\)
Exclusion Criteria
- •1\. Significant speech or cognitive impairment which will impede assessment. Participants must be able to understand and complete assessments (Abbreviated Mental Test Score \[AMTS] \>5 and Sheffield Aphasia score above age defined cut offs for receptive dysphasia).
- •2\. Other significant upper limb impairment e.g. fracture or frozen shoulder within six months, severe arthritis, amputation
- •3\. Evidence of contracture
- •4\. Female patients who are pregnant or lactating or who are not willing to take adequate precautions against pregnancy for the duration of the study
- •5\. Diagnosis likely to interfere with rehabilitation or outcome assessments e.g. registered blind, malignancy
- •6\. Other diagnosis which may contribute to upper limb spasticity e.g. multiple sclerosis, cerebral palsy
- •7\. Contraindications to intramuscular injection
- •8\. Religious objections to blood products (botulinum toxin contains human albumen)
- •9\. Contraindications to botulinum toxin which include bleeding disorders, myasthenia gravis and concurrent use of aminogycosides
- •10\. Use of botulinum toxin to the upper limb in the previous three months
Outcomes
Primary Outcomes
Not specified
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