Contact information
Type
Scientific
Primary contact
Dr Helen Rodgers
ORCID ID
Contact details
School of Population & Health Sciences
University of Newcastle
The Medical School
Newcastle upon Tyne
NE2 4HH
United Kingdom
+44 (0)191 222 6779
helen.rodgers@ncl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 02/41/06
Study information
Scientific title
Acronym
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Upper limb spasticity due to stroke
Intervention
Intervention: Botulinum toxin plus upper limb therapy programme
Control: Upper limb therapy programme alone
Intervention type
Drug
Phase
Not Specified
Drug names
Botulinum toxin
Primary outcome measure
Action Research Arm Test (ARAT).
Secondary outcome measures
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).
Overall trial start date
01/02/2005
Overall trial end date
28/02/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
390
Participant 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
Recruitment start date
01/02/2005
Recruitment end date
28/02/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
School of Population & Health Sciences
Newcastle upon Tyne
NE2 4HH
United Kingdom
Sponsor information
Organisation
The Newcastle Upon Tyne Hospitals NHS Foundation Trust (UK)
Sponsor details
The Newcastle upon Tyne Hospitals NHS Trust
Freeman Hospital
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Industry
Funder name
NIHR Health Technology Assessment Programme - HTA (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20515600
Publication citations
-
Results
Shaw L, Rodgers H, Price C, van Wijck F, Shackley P, Steen N, Barnes M, Ford G, Graham L, , BoTULS: a multicentre randomised controlled trial to evaluate the clinical effectiveness and cost-effectiveness of treating upper limb spasticity due to stroke with botulinum toxin type A., Health Technol Assess, 2010, 14, 26, 1-113, iii-iv, doi: 10.3310/hta14260.