| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN78533119 |
| Date ISRCTN assigned | 06/08/2004 |
| Local reference number(s) | HTA 02/41/06 |
| Public title | What is the clinical effect and cost effectiveness of treating upper limb spasticity due to stroke with botulinum toxin? |
| Scientific title |
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| Acronym | N/A |
| Disease/condition/study domain | Upper limb spasticity due to stroke |
| 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| 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 |
| Patient information material |
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| Anticipated start date | 01/02/2005 |
| Anticipated end date | 31/07/2008 |
| Status of trial | Ongoing |
| 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) |
| Sponsor name | 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
United Kingdom
NE7 7DN |
| Sponsor website | http://www.newcastle-hospitals.org.uk/ |
| Contact name | Dr Helen Rodgers |
| Contact details | School of Population & Health Sciences
University of Newcastle
The Medical School
Newcastle upon Tyne
United Kingdom
NE2 4HH |
| Contact telephone | +44 (0)191 222 6779 |
| Contact fax | +44 (0)191 222 6461 |
| Contact email | helen.rodgers@ncl.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN78533119 |
| Date last extracted from ISRCTN register | 17/04/2008 |
