Upper limb spasticity due to stroke Circulatory System Stroke
Conditions
Interventions
Intervention: Botulinum toxin plus upper limb therapy programme
Control: Upper limb therapy programme alone
Sponsors
The Newcastle Upon Tyne Hospitals NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Action Research Arm Test (ARAT). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
United Kingdom
Outcome results
None listed