Browsing by Person "Barnes, Michael"

Now showing 1 - 2 of 2

Study design and methods of the BoTULS trial: a randomised controlled trial to evaluate the clinical effect and cost effectiveness of treating upper limb spasticity due to stroke with botulinum toxin type A
(BioMed Central, 2008-10) Rodgers, Helen; Shaw, Lisa; Price, Christopher; van Wijck, Frederike; Barnes, Michael; Graham, Laura; Ford, Gary; Shackley, Phil; Steen, Nick; BoTULS investigators, On behalf of
Background Following a stroke, 55-75% of patients experience upper limb problems in the longer term. Upper limb spasticity may cause pain, deformity and reduced function, affecting mood and independence. Botulinum toxin is used increasingly to treat focal spasticity, but its impact on upper limb function after stroke is unclear. The aim of this study is to evaluate the clinical and cost effectiveness of botulinum toxin type A plus an upper limb therapy programme in the treatment of post stroke upper limb spasticity. Methods Trial design : A multi-centre open label parallel group randomised controlled trial and economic evaluation. Participants : Adults with upper limb spasticity at the shoulder, elbow, wrist or hand and reduced upper limb function due to stroke more than 1 month previously. Interventions : Botulinum toxin type A plus upper limb therapy (intervention group) or upper limb therapy alone (control group). Outcomes : Outcome assessments are undertaken at 1, 3 and 12 months. The primary outcome is upper limb function one month after study entry measured by the Action Research Arm Test (ARAT). Secondary outcomes include: spasticity (Modified Ashworth Scale); grip strength; dexterity (Nine Hole Peg Test); disability (Barthel Activities of Daily Living Index); quality of life (Stroke Impact Scale, Euroqol EQ-5D) and attainment of patient-selected goals (Canadian Occupational Performance Measure). Health and social services resource use, adverse events, use of other antispasticity treatments and patient views on the treatment will be compared. Participants are clinically reassessed at 3, 6 and 9 months to determine the need for repeat botulinum toxin type A and/or therapy. Randomisation : A web based central independent randomisation service. Blinding : Outcome assessments are undertaken by an assessor who is blinded to the randomisation group. Sample size : 332 participants provide 80% power to detect a 15% difference in treatment successes between intervention and control groups. Treatment success is defined as improvement of 3 points for those with a baseline ARAT of 0-3 and 6 points for those with ARAT of 4-56.
The construct validity of a spasticity measurement device for clinical practice: An alternative to the Ashworth scales
(Taylor & Francis, 2006-05) Pandyan, Anand; van Wijck, Frederike; Stark, Sandra; Vuadens, Philippe; Johnson, Garth; Barnes, Michael
Introduction. Spasticity is a significant cause of disability in people with an upper motor neurone lesion, but there is a paucity of appropriate outcome measures to evaluate this phenomenon. The aim was to test the construct validity of a clinically relevant, non-invasive measure of spasticity. Methods. A cross-section study design in which participants with elbow flexor spasticity and capable of providing written informed consent were recruited. Results. Fourteen stroke patients participated (six female and eight male). Median age was 61 years and the median time post stroke was 48 months. Six patients had a MAS grading of '1+', three a grade of '2' and five a grade of '3'. The velocity of the brisk stretch was significantly higher than that of the slow stretch (p < 0.05: median difference, 34/s: IQR, 20 - 46). Flexor muscle activity during the brisk stretch was significantly higher than that of the slow stretch (p < 0.05: median difference, 2.0 _V; IQR, 0.4 - 8.4). In contrast the RPE was not significantly different between the slow and the fast stretches (p > 0.1: median difference, 0.07 N/deg; IQR, - 0.09 - 0.16). There were no patterns of association between the MAS, elbow flexor muscle activity and RPE. Other important observations, in some patients, were: continuous background muscle activation consistent with descriptions of spastic dystonia; muscle activity at the slow velocity stretch; muscle activation patterns consistent with the clasp-knife phenomenon. Conclusions. The measurement system was capable of measuring spasticity as defined by Lance (1980; In: Lance et al., editors. Spasticity: disordered motor control. Chicago, IL: Year Book. p 185 - 204). In addition, it enabled various other clinical phenomena associated with spasticity to be measured. Assessing spasticity by measuring changes in resistance to passive movement only may not be sufficient, as the latter is influenced by many factors of which spasticity may only be one. Further work is now required to investigate repeatability and sensitivity.