Cerebrovascular Accident, Muscle Spasticity
Conditions
Brief summary
The main purpose of this study is to assess the effect on Quality of Life of two cycles of Dysport treatment on post-stroke spasticity of the upper limb. The effect of treatment on spasticity and function will also be measured.
Interventions
BIOLOGICALBotulinum toxin type A
DRUGPlacebo
Sponsors
Ipsen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient has suffered a stroke, as defined by the World Health Organisation (WHO) criteria, at least 6 months previously. * The patient has a hemiparetic arm and meets minimum score requirements on the Modified Ashworth Scale. * The patient has the cognitive and communication ability to participate in the study.
Exclusion criteria
* Patients who have received botulinum toxin treatment within the past 120 days. * Contraindication to botulinum toxin treatment. * Patients who are receiving oral anti-spasticity medication and who have had a change in dosage of this medication in the month prior to study entry. * Patients who have previously been treated with phenol for their upper limb spasticity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in quality of life measured using the Assessment of Quality of Life questionnaire (12 question version). | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the Modified Motor Assessment Scale | — |
| Change in patient disability and carer burden rating scale total score | — |
| Achievement of the patient identified functional outcome measures (Goal Attainment Scaling) | — |
| Change in muscle spasticity assessed on Modified Ashworth Scale (MAS) | — |
| Change in depression rating scale total score | — |
| Global assessment of benefit | — |
| Change in the degree of pain | — |
Countries
Australia
Outcome results
None listed