Condition category
Circulatory System
Date applied
06/08/2004
Date assigned
06/08/2004
Last edited
07/12/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.newcastle-hospitals.org.uk/

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

Results - basic reporting

Publication summary

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20515600

Publication citations

  1. 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.

Additional files

Editorial Notes