What is the clinical effect and cost effectiveness of treating upper limb spasticity due to stroke with botulinum toxin?
| ISRCTN | ISRCTN78533119 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78533119 |
| Protocol serial number | HTA 02/41/06 |
| Sponsor | The Newcastle Upon Tyne Hospitals NHS Foundation Trust (UK) |
| Funder | NIHR Health Technology Assessment Programme - HTA (UK) |
- Submission date
- 06/08/2004
- Registration date
- 06/08/2004
- Last edited
- 07/12/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Helen Rodgers
Scientific
Scientific
School of Population & Health Sciences
University of Newcastle
The Medical School
Newcastle upon Tyne
NE2 4HH
United Kingdom
| Phone | +44 (0)191 222 6779 |
|---|---|
| helen.rodgers@ncl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Botulinum toxin |
| Primary outcome measure(s) |
Action Research Arm Test (ARAT). |
| Key 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). |
| Completion date | 28/02/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 390 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 01/02/2005 |
| Date of final enrolment | 28/02/2009 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
School of Population & Health Sciences
Newcastle upon Tyne
NE2 4HH
United Kingdom
NE2 4HH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2010 | Yes | No |
