Long-term effect of additional rehabilitation following botulinum toxin-A on upper limb activity in chronic stroke: the InTENSE randomised trial
Abstract Background It is common for people with persistent spasticity due to a stroke to receive an injection of botulinum toxin-A in the upper limb, however post-injection intervention varies. Aim To determine the long-term effect of additional upper limb rehabilitation following botulinum toxin-A...
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BMC
2022-04-01
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Series: | BMC Neurology |
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Online Access: | https://doi.org/10.1186/s12883-022-02672-8 |
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author | Natasha A. Lannin Louise Ada Coralie English Julie Ratcliffe Steven Faux Mithu Palit Senen Gonzalez John Olver Emma Schneider Maria Crotty Ian D. Cameron |
author_facet | Natasha A. Lannin Louise Ada Coralie English Julie Ratcliffe Steven Faux Mithu Palit Senen Gonzalez John Olver Emma Schneider Maria Crotty Ian D. Cameron |
author_sort | Natasha A. Lannin |
collection | DOAJ |
description | Abstract Background It is common for people with persistent spasticity due to a stroke to receive an injection of botulinum toxin-A in the upper limb, however post-injection intervention varies. Aim To determine the long-term effect of additional upper limb rehabilitation following botulinum toxin-A in chronic stroke. Method An analysis of long-term outcomes from national, multicenter, Phase III randomised trial with concealed allocation, blinded measurement and intention-to-treat analysis was carried out. Participants were 140 stroke survivors who were scheduled to receive botulinum toxin-A in any muscle(s) that cross the wrist because of moderate to severe spasticity after a stroke greater than 3 months ago, who had completed formal rehabilitation and had no significant cognitive impairment. Experimental group received botulinum toxin-A plus 3 months of evidence-based movement training while the control group received botulinum toxin-A plus a handout of exercises. Primary outcomes were goal attainment (Goal Attainment Scale) and upper limb activity (Box and Block Test) at 12 months (ie, 9 months beyond the intervention). Secondary outcomes were spasticity, range of motion, strength, pain, burden of care, and health-related quality of life. Results By 12 months, the experimental group scored the same as the control group on the Goal Attainment Scale (MD 0 T-score, 95% CI -5 to 5) and on the Box and Block Test (MD 0.01 blocks/s, 95% CI -0.01 to 0.03). There were no differences between groups on any secondary outcome. Conclusion Additional intensive upper limb rehabilitation following botulinum toxin-A in chronic stroke survivors with a disabled upper limb is not more effective in the long-term. Trial Registration ACTRN12615000616572 (12/06/2015). |
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language | English |
last_indexed | 2024-04-13T03:54:52Z |
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spelling | doaj.art-b6d9f417c7754ae3abe5d67dfdd2a7492022-12-22T03:03:40ZengBMCBMC Neurology1471-23772022-04-012211810.1186/s12883-022-02672-8Long-term effect of additional rehabilitation following botulinum toxin-A on upper limb activity in chronic stroke: the InTENSE randomised trialNatasha A. Lannin0Louise Ada1Coralie English2Julie Ratcliffe3Steven Faux4Mithu Palit5Senen Gonzalez6John Olver7Emma Schneider8Maria Crotty9Ian D. Cameron10Department of Neurosciences, Central Clinical School, Monash UniversityThe University of SydneySchool of Health Sciences and Priority Research Centre for Stroke and Brain Injury, University of NewcastleCollege of Nursing and Health Sciences, Flinders UniversitySacred Heart Rehabilitation Unit, St Vincent’s HospitalAlfred HealthAustin HealthEpworth Monash Rehabilitation Medicine Research Unit, Monash UniversityDepartment of Neurosciences, Central Clinical School, Monash UniversityCollege of Nursing and Health Sciences, Flinders UniversityJohn Walsh Centre for Rehabilitation Research, Northern Sydney Local Health DistrictAbstract Background It is common for people with persistent spasticity due to a stroke to receive an injection of botulinum toxin-A in the upper limb, however post-injection intervention varies. Aim To determine the long-term effect of additional upper limb rehabilitation following botulinum toxin-A in chronic stroke. Method An analysis of long-term outcomes from national, multicenter, Phase III randomised trial with concealed allocation, blinded measurement and intention-to-treat analysis was carried out. Participants were 140 stroke survivors who were scheduled to receive botulinum toxin-A in any muscle(s) that cross the wrist because of moderate to severe spasticity after a stroke greater than 3 months ago, who had completed formal rehabilitation and had no significant cognitive impairment. Experimental group received botulinum toxin-A plus 3 months of evidence-based movement training while the control group received botulinum toxin-A plus a handout of exercises. Primary outcomes were goal attainment (Goal Attainment Scale) and upper limb activity (Box and Block Test) at 12 months (ie, 9 months beyond the intervention). Secondary outcomes were spasticity, range of motion, strength, pain, burden of care, and health-related quality of life. Results By 12 months, the experimental group scored the same as the control group on the Goal Attainment Scale (MD 0 T-score, 95% CI -5 to 5) and on the Box and Block Test (MD 0.01 blocks/s, 95% CI -0.01 to 0.03). There were no differences between groups on any secondary outcome. Conclusion Additional intensive upper limb rehabilitation following botulinum toxin-A in chronic stroke survivors with a disabled upper limb is not more effective in the long-term. Trial Registration ACTRN12615000616572 (12/06/2015). https://doi.org/10.1186/s12883-022-02672-8Botulinum toxin type AStrokeSpasticityWristRehabilitationNeuroscience |
spellingShingle | Natasha A. Lannin Louise Ada Coralie English Julie Ratcliffe Steven Faux Mithu Palit Senen Gonzalez John Olver Emma Schneider Maria Crotty Ian D. Cameron Long-term effect of additional rehabilitation following botulinum toxin-A on upper limb activity in chronic stroke: the InTENSE randomised trial BMC Neurology Botulinum toxin type A Stroke Spasticity Wrist Rehabilitation Neuroscience |
title | Long-term effect of additional rehabilitation following botulinum toxin-A on upper limb activity in chronic stroke: the InTENSE randomised trial |
title_full | Long-term effect of additional rehabilitation following botulinum toxin-A on upper limb activity in chronic stroke: the InTENSE randomised trial |
title_fullStr | Long-term effect of additional rehabilitation following botulinum toxin-A on upper limb activity in chronic stroke: the InTENSE randomised trial |
title_full_unstemmed | Long-term effect of additional rehabilitation following botulinum toxin-A on upper limb activity in chronic stroke: the InTENSE randomised trial |
title_short | Long-term effect of additional rehabilitation following botulinum toxin-A on upper limb activity in chronic stroke: the InTENSE randomised trial |
title_sort | long term effect of additional rehabilitation following botulinum toxin a on upper limb activity in chronic stroke the intense randomised trial |
topic | Botulinum toxin type A Stroke Spasticity Wrist Rehabilitation Neuroscience |
url | https://doi.org/10.1186/s12883-022-02672-8 |
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