Welcome
Support Centre
20 October 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
What is the clinical effect and cost effectiveness of treating upper limb spasticity due to stroke with botulinum toxin?
ISRCTN ISRCTN78533119
DOI 10.1186/ISRCTN78533119
ClinicalTrials.gov identifier
EudraCT number
Public title What is the clinical effect and cost effectiveness of treating upper limb spasticity due to stroke with botulinum toxin?
Scientific title
Acronym N/A
Serial number at source HTA 02/41/06
Study hypothesis Objective: To compare the upper limb (UL) function of patients with spasticity due to stroke who receive botulinum toxin injection(s) to the upper arm plus a four week evidence based UL therapy programme (intervention group) with patients who receive the UL therapy programme alone (control group) at 1 month after study entry.

Protocol can be found at http://www.hta.ac.uk/protocols/200200410006.pdf
More details can be found at http://www.hta.ac.uk/1408

Please note that, as of 26/08/2009, the anticipated end date of this trial has been updated from 31/07/2008 to 28/02/2009.
Lay summary
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Upper limb spasticity due to stroke
Participants - 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)
Participants - 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
Anticipated start date 01/02/2005
Anticipated end date 28/02/2009
Status of trial Completed
Patient information material
Target number of participants 390
Interventions Intervention: Botulinum toxin plus upper limb therapy programme
Control: Upper limb therapy programme alone
Primary outcome measure(s) Action Research Arm Test (ARAT).
Secondary outcome measure(s) 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).
Sources of funding NIHR Health Technology Assessment Programme - HTA (UK)
Trial website
Publications 1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20515600
Contact name Dr  Helen  Rodgers
  Address School of Population & Health Sciences
University of Newcastle
The Medical School
  City/town Newcastle upon Tyne
  Zip/Postcode NE2 4HH
  Country United Kingdom
  Tel +44 (0)191 222 6779
  Fax +44 (0)191 222 6461
  Email helen.rodgers@ncl.ac.uk
Sponsor The Newcastle Upon Tyne Hospitals NHS Foundation Trust (UK)
  Address The Newcastle upon Tyne Hospitals NHS Trust
Freeman Hospital
Freeman Road
High Heaton
  City/town Newcastle upon Tyne
  Zip/Postcode NE7 7DN
  Country United Kingdom
  Sponsor website: http://www.newcastle-hospitals.org.uk/
Date applied 06/08/2004
Last edited 07/12/2010
Date ISRCTN assigned 06/08/2004
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.