Clinical Trial

. 2020 Feb;51(2):556-562.

doi: 10.1161/STROKEAHA.119.027602. Epub 2019 Dec 9.

Effect of Additional Rehabilitation After Botulinum Toxin-A on Upper Limb Activity in Chronic Stroke: The InTENSE Trial

Natasha A Lannin^{1

2}, Louise Ada³, Coralie English⁴, Julie Ratcliffe⁵, Steven G Faux^{6

7}, Mithu Palit², Senen Gonzalez⁸, John Olver⁹, Ian Cameron¹⁰, Maria Crotty¹¹; InTENSE Trial Group

Collaborators, Affiliations

Collaborators

InTENSE Trial Group:
Malcolm Bowman, Rachel Milte, Angela Vratsistas-Curto, Annabel McNamara, Christine Shiner, Elizabeth Lynch, Emma Schneider, Louise Beaumont, Maggie Killington, Megan Coulter, Doungkamol Sindhusake, Brian Anthonisz, Hong Mei Khor, Justin Tan, Kwong Teo, Lily Ng, Lydia Huang, Maria Paul, Neil Simon, Nidhi Gupta, Rebecca Martens, Sam Bolitho, Shea Morrison, Sue Hooper, Yan Chow, Yuriko Watanabe, Adrian Cowling, Clara Flu, Debbie Edwards, Emily Toma, Genevieve Hendrey, Jacinta Sheehan, Josh Butler, Judith Hocking, Lauren Rutzou, Megan White, Michael Snigg, Rhiannon Hughes, Sarah Sweeney, Sophie Flint, Tam Levy, Val Bramah, Cameron Lathlean, Carrie McCallum, Elaine Chui, Frances Allan, Heather Webber, Jenna Cameron, Jo Campbell, Julie Lawson, Kalavani Zenouith, Karen Borschmann, Katelyn Moloney, Laura Jolliffe, Lisa Cameron, Owen Howlett, Rebecca Nicks, Sophie O'Keefe

Affiliations

¹ From the Department of Neurosciences, Central Clinical School (N.A.L.), Monash University, Melbourne, Victoria, Australia.
² Alfred Health, Melbourne, Victoria, Australia (N.A.L., M.P.).
³ Faculty of Health Sciences (Physiotherapy) (L.A.), The University of Sydney, New South Wales, Australia.
⁴ School of Health Sciences and Priority Research Centre for Stroke and Brain Injury, University of Newcastle, New South Wales, Australia (C.E.).
⁵ College of Nursing and Health Sciences (J.R.), Flinders University, Adelaide, South Australia, Australia.
⁶ Sacred Heart Rehabilitation Unit, St Vincent's Hospital, Sydney, New South Wales, Australia (S.G.F.).
⁷ School of Medicine, University of New South Wales, Sydney, New South Wales, Australia (S.G.F.).
⁸ Austin Health, Melbourne, Victoria, Australia (S.G.).
⁹ Epworth Monash Rehabilitation Medicine Research Unit (J.O.), Monash University, Melbourne, Victoria, Australia.
¹⁰ John Walsh Centre for Rehabilitation Research (I.C.), The University of Sydney, New South Wales, Australia.
¹¹ Rehabilitation and Aged Care, College of Medicine and Public Health (M.C.), Flinders University, Adelaide, South Australia, Australia.

PMID: 31813359
PMCID: PMC7004444
DOI: 10.1161/STROKEAHA.119.027602

Clinical Trial

Effect of Additional Rehabilitation After Botulinum Toxin-A on Upper Limb Activity in Chronic Stroke: The InTENSE Trial

Natasha A Lannin et al. Stroke. 2020 Feb.

. 2020 Feb;51(2):556-562.

doi: 10.1161/STROKEAHA.119.027602. Epub 2019 Dec 9.

Authors

Collaborators

InTENSE Trial Group:
Malcolm Bowman, Rachel Milte, Angela Vratsistas-Curto, Annabel McNamara, Christine Shiner, Elizabeth Lynch, Emma Schneider, Louise Beaumont, Maggie Killington, Megan Coulter, Doungkamol Sindhusake, Brian Anthonisz, Hong Mei Khor, Justin Tan, Kwong Teo, Lily Ng, Lydia Huang, Maria Paul, Neil Simon, Nidhi Gupta, Rebecca Martens, Sam Bolitho, Shea Morrison, Sue Hooper, Yan Chow, Yuriko Watanabe, Adrian Cowling, Clara Flu, Debbie Edwards, Emily Toma, Genevieve Hendrey, Jacinta Sheehan, Josh Butler, Judith Hocking, Lauren Rutzou, Megan White, Michael Snigg, Rhiannon Hughes, Sarah Sweeney, Sophie Flint, Tam Levy, Val Bramah, Cameron Lathlean, Carrie McCallum, Elaine Chui, Frances Allan, Heather Webber, Jenna Cameron, Jo Campbell, Julie Lawson, Kalavani Zenouith, Karen Borschmann, Katelyn Moloney, Laura Jolliffe, Lisa Cameron, Owen Howlett, Rebecca Nicks, Sophie O'Keefe

Affiliations

¹ From the Department of Neurosciences, Central Clinical School (N.A.L.), Monash University, Melbourne, Victoria, Australia.
² Alfred Health, Melbourne, Victoria, Australia (N.A.L., M.P.).
³ Faculty of Health Sciences (Physiotherapy) (L.A.), The University of Sydney, New South Wales, Australia.
⁴ School of Health Sciences and Priority Research Centre for Stroke and Brain Injury, University of Newcastle, New South Wales, Australia (C.E.).
⁵ College of Nursing and Health Sciences (J.R.), Flinders University, Adelaide, South Australia, Australia.
⁶ Sacred Heart Rehabilitation Unit, St Vincent's Hospital, Sydney, New South Wales, Australia (S.G.F.).
⁷ School of Medicine, University of New South Wales, Sydney, New South Wales, Australia (S.G.F.).
⁸ Austin Health, Melbourne, Victoria, Australia (S.G.).
⁹ Epworth Monash Rehabilitation Medicine Research Unit (J.O.), Monash University, Melbourne, Victoria, Australia.
¹⁰ John Walsh Centre for Rehabilitation Research (I.C.), The University of Sydney, New South Wales, Australia.
¹¹ Rehabilitation and Aged Care, College of Medicine and Public Health (M.C.), Flinders University, Adelaide, South Australia, Australia.

PMID: 31813359
PMCID: PMC7004444
DOI: 10.1161/STROKEAHA.119.027602

Erratum in

Correction to: Effect of Additional Rehabilitation After Botulinum Toxin-A on Upper Limb Activity in Chronic Stroke: The InTENSE Trial.
[No authors listed] [No authors listed] Stroke. 2020 Feb;51(2):e45. doi: 10.1161/STR.0000000000000219. Epub 2020 Jan 27. Stroke. 2020. PMID: 31986111 Free PMC article. No abstract available.

Abstract

Background and Purpose- The aim of this trial was to determine the effect of additional upper limb rehabilitation following botulinum toxin-A for upper limb activity in chronic stroke. Methods- We conducted a multicenter phase III randomized trial with concealed allocation, blinded measurement, and intention-to-treat analysis. One hundred forty 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 >3 months ago, who had completed formal rehabilitation and had no significant cognitive impairment. Experimental group received botulinum toxin-A plus evidence-based movement training while the control group received botulinum toxin-A plus a handout of exercises. Primary outcomes were goal attainment (Goal Attainment Scaling) and upper limb activity (Box and Block Test) at 3 months (end of intervention). Secondary outcomes were spasticity, range of motion, strength, pain, burden of care, and health-related quality of life. Results- In terms of goal attainment, the experimental group scored the same (mean difference, 2 T-score [95% CI, -2 to 7]) as the control group on the Goal Attainment Scale. In terms of upper limb activity, by 3 months the experimental group moved blocks at the same speed (mean difference, 0.00 blocks/s [95% CI, -0.02 to 0.01]) as the control group on the Box and Block Test. There were no differences between groups on any secondary outcome except strength, in favor of the experimental group (mean difference, 1.4 kg [95% CI, 0.2-2.7]). Conclusions- Findings suggest that additional intensive upper limb rehabilitation following botulinum toxin-A in chronic stroke survivors with a disabled upper limb is not effective. Registration- URL: https://www.clinicaltrials.gov. Unique identifier: ACTRN12615000616572.

Keywords: botulinum toxin type A; neuroscience; pain; quality of life; spasticity; wrist.

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Comment in

Critically appraised paper: Additional rehabilitation following botulinum toxin-A does not improve goal attainment and upper limb activity in chronic stroke survivors [synopsis].
Spittle AJ. Spittle AJ. J Physiother. 2021 Jul;67(3):217. doi: 10.1016/j.jphys.2021.05.005. Epub 2021 May 28. J Physiother. 2021. PMID: 34053900 No abstract available.

References

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Effect of Additional Rehabilitation After Botulinum Toxin-A on Upper Limb Activity in Chronic Stroke: The InTENSE Trial

Collaborators

Affiliations

Effect of Additional Rehabilitation After Botulinum Toxin-A on Upper Limb Activity in Chronic Stroke: The InTENSE Trial

Authors

Collaborators

Affiliations

Erratum in

Abstract

Figures

Comment in

References

Publication types

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Full Text Sources

Medical