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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dysport | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin type A | Biological |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in quality of life measured using the Assessment of Quality of Life questionnaire (12 question version). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in muscle spasticity assessed on Modified Ashworth Scale (MAS) | ||
| Change in the Modified Motor Assessment Scale | ||
| Change in patient disability and carer burden rating scale total score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Josephs Hospital | Auburn | New South Wales | 2144 | Australia | ||
| Royal Prince Alfred Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20111849 | Derived | Turner-Stokes L, Baguley IJ, De Graaff S, Katrak P, Davies L, McCrory P, Hughes A. Goal attainment scaling in the evaluation of treatment of upper limb spasticity with botulinum toxin: a secondary analysis from a double-blind placebo-controlled randomized clinical trial. J Rehabil Med. 2010 Jan;42(1):81-9. doi: 10.2340/16501977-0474. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D009128 | Muscle Spasticity |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| C542869 | abobotulinumtoxinA |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| Placebo |
| Drug |
|
| Achievement of the patient identified functional outcome measures (Goal Attainment Scaling) |
| Change in the degree of pain |
| Change in depression rating scale total score |
| Global assessment of benefit |
| Camperdown |
| New South Wales |
| 2050 |
| Australia |
| Prince of Wales Hospital | Randwick | New South Wales | 2031 | Australia |
| Box Hill Hospital | Box Hill | Victoria | 3128 | Australia |
| Caulfield General Medical Centre | Caulfield | Victoria | 3162 | Australia |
| Austin Health | Heidelberg | Victoria | 3084 | Australia |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |