ISRCTN78533119已完成不适用
What is the clinical effect and cost effectiveness of treating upper limb spasticity due to stroke with botulinum toxin?
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 390
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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)
排除标准
- •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
- •11. Known allergy or hypersensitivity to any of the test compounds
研究者
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