Rodgers, H., Shaw, L., Price, C. et al. (7 more authors) (2008) Study design and methods of the BoTULS trial: a randomised controlled trial to evaluate the clinical effect and cost effectiveness of treating upper limb spasticity due to stroke with botulinum toxin type A. Trials, 9. 59. ISSN 1745-6215
Abstract
Background Following a stroke, 55–75% of patients experience upper limb problems in the longer term. Upper limb spasticity may cause pain, deformity and reduced function, affecting mood and independence. Botulinum toxin is used increasingly to treat focal spasticity, but its impact on upper limb function after stroke is unclear.
The aim of this study is to evaluate the clinical and cost effectiveness of botulinum toxin type A plus an upper limb therapy programme in the treatment of post stroke upper limb spasticity.
Methods Trial design : A multi-centre open label parallel group randomised controlled trial and economic evaluation.
Participants : Adults with upper limb spasticity at the shoulder, elbow, wrist or hand and reduced upper limb function due to stroke more than 1 month previously.
Interventions : Botulinum toxin type A plus upper limb therapy (intervention group) or upper limb therapy alone (control group).
Outcomes : Outcome assessments are undertaken at 1, 3 and 12 months. The primary outcome is upper limb function one month after study entry measured by the Action Research Arm Test (ARAT). Secondary outcomes include: spasticity (Modified Ashworth Scale); grip strength; dexterity (Nine Hole Peg Test); disability (Barthel Activities of Daily Living Index); quality of life (Stroke Impact Scale, Euroqol EQ-5D) and attainment of patient-selected goals (Canadian Occupational Performance Measure). Health and social services resource use, adverse events, use of other antispasticity treatments and patient views on the treatment will be compared. Participants are clinically reassessed at 3, 6 and 9 months to determine the need for repeat botulinum toxin type A and/or therapy.
Randomisation : A web based central independent randomisation service.
Blinding : Outcome assessments are undertaken by an assessor who is blinded to the randomisation group.
Sample size : 332 participants provide 80% power to detect a 15% difference in treatment successes between intervention and control groups. Treatment success is defined as improvement of 3 points for those with a baseline ARAT of 0–3 and 6 points for those with ARAT of 4–56.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2008 Rodgers et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
Keywords: | PLACEBO-CONTROLLED TRIAL; TRAINING IMPROVES PERFORMANCE; UPPER EXTREMITY SPASTICITY; DOUBLE-BLIND; ARM FUNCTION; UNILATERAL STROKE; RECOVERY; EFFICACY; IMPACT; STRENGTH |
Dates: |
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Institution: | The University of Sheffield |
Academic Units: | The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > School of Health and Related Research (Sheffield) > ScHARR - Sheffield Centre for Health and Related Research |
Depositing User: | Symplectic Sheffield |
Date Deposited: | 11 May 2017 09:05 |
Last Modified: | 23 Jun 2017 15:18 |
Published Version: | https://doi.org/10.1186/1745-6215-9-59 |
Status: | Published |
Publisher: | BioMed Central |
Refereed: | Yes |
Identification Number: | 10.1186/1745-6215-9-59 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:115424 |