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

Completed

• Conditions: Stroke; pper limb spasticity due to stroke; Circulatory System

• Registration Number: ISRCTN78533119
• Lead Sponsor: The Newcastle Upon Tyne Hospitals NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08-06
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 390

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
11. Known allergy or hypersensitivity to any of the test compounds

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Action Research Arm Test (ARAT).

Secondary Outcome Measures

Name	Time	Method
ARAT at 3 and 12 months, Nine Hole Peg Test; biomechanical assessment of spasticity; motor impairment (Motricity Index and grip strength by dynamometer); UL pain (numerical rating scale). Assessment of patient-selected UL goals; disability (Barthel ADL Index); and quality of life (Stroke Impact Scale and EQ-5D).