Does low-dose botulinum toxin help the recovery of arm function when given early after stroke? A phase II randomized controlled pilot study to estimate effect size
Authors: Cousins, E., Ward, A., Roffe, C., Rimington, L. and Pandyan, A.
Journal: Clinical Rehabilitation
Volume: 24
Issue: 6
Pages: 501-513
eISSN: 1477-0873
ISSN: 0269-2155
DOI: 10.1177/0269215509358945
Abstract:Objective: Spasticity after stroke may be associated with worse functional outcome. Our study aim is to establish whether a low dose of botulinum toxin, given early post stroke before clinically evident spasticity warrants treatment, will improve recovery of arm function. Design: A double-blind randomized placebo-controlled trial. Setting: An acute stroke unit. Subjects: Individuals recruited within three weeks of stroke onset with severe arm function deficits. Interventions: Injections of quarter and half standard dose botulinum toxin A to the upper limb, with a control of normal saline injections. Main measures: Arm function, active and passive movement, and spasticity at elbow and wrist were recorded at baseline, and at 4, 8, 12 and 20 weeks post intervention. A pre-planned subgroup analysis included only subjects with no arm function at baseline (Action Research Arm Test score = 0). Results: Thirty subjects were recruited, and 21 completed all assessments. Arm function scores improved in all three groups between baseline and week 20. There was no benefit for active treatment over control in the whole group analysis. In the subgroup analysis the active groups improved when compared with the control group and effect sizes for improvement in this subgroup were 0.6 and 0.5 for the quarter dose and half dose groups respectively. Conclusions: Individuals with no arm function within three weeks of stroke may benefit functionally from botulinum toxin. Using the effect size of 0.5, further studies would need a minimum of 101 participants in each group to confirm this finding. © The Author(s), 2010.
Source: Scopus
Does low-dose botulinum toxin help the recovery of arm function when given early after stroke? A phase II randomized controlled pilot study to estimate effect size.
Authors: Cousins, E., Ward, A., Roffe, C., Rimington, L. and Pandyan, A.
Journal: Clin Rehabil
Volume: 24
Issue: 6
Pages: 501-513
eISSN: 1477-0873
DOI: 10.1177/0269215509358945
Abstract:OBJECTIVE: Spasticity after stroke may be associated with worse functional outcome. Our study aim is to establish whether a low dose of botulinum toxin, given early post stroke before clinically evident spasticity warrants treatment, will improve recovery of arm function. DESIGN: A double-blind randomized placebo-controlled trial. SETTING: An acute stroke unit. SUBJECTS: Individuals recruited within three weeks of stroke onset with severe arm function deficits. INTERVENTIONS: Injections of quarter and half standard dose botulinum toxin A to the upper limb, with a control of normal saline injections. MAIN MEASURES: Arm function, active and passive movement, and spasticity at elbow and wrist were recorded at baseline, and at 4, 8, 12 and 20 weeks post intervention. A pre-planned subgroup analysis included only subjects with no arm function at baseline (Action Research Arm Test score = 0). RESULTS: Thirty subjects were recruited, and 21 completed all assessments. Arm function scores improved in all three groups between baseline and week 20. There was no benefit for active treatment over control in the whole group analysis. In the subgroup analysis the active groups improved when compared with the control group and effect sizes for improvement in this subgroup were 0.6 and 0.5 for the quarter dose and half dose groups respectively. CONCLUSIONS: Individuals with no arm function within three weeks of stroke may benefit functionally from botulinum toxin. Using the effect size of 0.5, further studies would need a minimum of 101 participants in each group to confirm this finding.
Source: PubMed
Does low-dose botulinum toxin help the recovery of arm function when given early after stroke? A phase II randomized controlled pilot study to estimate effect size
Authors: Cousins, E., Ward, A., Roffe, C., Rimington, L. and Pandyan, A.
Journal: CLINICAL REHABILITATION
Volume: 24
Issue: 6
Pages: 501-513
eISSN: 1477-0873
ISSN: 0269-2155
DOI: 10.1177/0269215509358945
Source: Web of Science (Lite)
Does low-dose botulinum toxin help the recovery of arm function when given early after stroke? A phase II randomized controlled pilot study to estimate effect size.
Authors: Cousins, E., Ward, A., Roffe, C., Rimington, L. and Pandyan, A.
Journal: Clinical rehabilitation
Volume: 24
Issue: 6
Pages: 501-513
eISSN: 1477-0873
ISSN: 0269-2155
DOI: 10.1177/0269215509358945
Abstract:Objective
Spasticity after stroke may be associated with worse functional outcome. Our study aim is to establish whether a low dose of botulinum toxin, given early post stroke before clinically evident spasticity warrants treatment, will improve recovery of arm function.Design
A double-blind randomized placebo-controlled trial.Setting
An acute stroke unit.Subjects
Individuals recruited within three weeks of stroke onset with severe arm function deficits.Interventions
Injections of quarter and half standard dose botulinum toxin A to the upper limb, with a control of normal saline injections.Main measures
Arm function, active and passive movement, and spasticity at elbow and wrist were recorded at baseline, and at 4, 8, 12 and 20 weeks post intervention. A pre-planned subgroup analysis included only subjects with no arm function at baseline (Action Research Arm Test score = 0).Results
Thirty subjects were recruited, and 21 completed all assessments. Arm function scores improved in all three groups between baseline and week 20. There was no benefit for active treatment over control in the whole group analysis. In the subgroup analysis the active groups improved when compared with the control group and effect sizes for improvement in this subgroup were 0.6 and 0.5 for the quarter dose and half dose groups respectively.Conclusions
Individuals with no arm function within three weeks of stroke may benefit functionally from botulinum toxin. Using the effect size of 0.5, further studies would need a minimum of 101 participants in each group to confirm this finding.Source: Europe PubMed Central