Assessing the effectiveness of upper-limb spasticity management using a structured approach to goal-setting and outcome measurement: First cycle results from the ulis-III study

Lynne Turner-Stokes; Jorge Jacinto; Klemens Fheodoroff; Allison Brashear; Pascal Maisonobe; Andreas Lysandropoulos; Stephen Ashford; Ian Baguley; Arun Aggarwal; John Olver; John Estell; Steven Faux; Edwin Luk; Katya Kotschet; Andrew Hughes; Rachael Nunan; Bernhard Haslinger; Petra Baum; Cornelia Mobius; Urban Fietzek; Ip Chi Wang; Tae Mo Chung; Régina Helena Chueire; Carla Heloisa Cabral Moro; Alexis Schnitzler; Claire Delleci; Anne Laure Ferrapie; Marie Eve Isner-Horobeti; Dominic Perennou; Ching Man Leung; Michela Cosma; Carlo Caltagirone; Manuela Diverio; Paolo Girlanda; Giancarlo Ianeri; Marzia Millevolte; Franco Molteni; Jorge Hernandez Franco; Juan Francisco Gomez Hernandez; Sandra Quinones Aguilar; Laura Patricia de la Lanza Andrade; Raymond Rosales; Jeanne Flordelis; Dariusz Koziorowski; Anna Potulska; Monika Rudzinska; Eduarda Afonso; Ana Rolo Duarte; Svetlana Khatkova; Alexey Korenko; Dina Khasanova; Dmitry Okhabov; Elena Arefyeva; Denis Karpov; Andrey Korolev; Yi Chung Lee; Sen Wei Tsai; Jessica Tate; Thomas L. Davis; Cynthia Marciniak; Atul Patel

doi:10.2340/16501977-2770

Assessing the effectiveness of upper-limb spasticity management using a structured approach to goal-setting and outcome measurement: First cycle results from the ulis-III study

Lynne Turner-Stokes, Jorge Jacinto, Klemens Fheodoroff, Allison Brashear, Pascal Maisonobe, Andreas Lysandropoulos, Stephen Ashford, Ian Baguley, Arun Aggarwal, John Olver, John Estell, Steven Faux, Edwin Luk, Katya Kotschet, Andrew Hughes, Rachael Nunan, Bernhard Haslinger, Petra Baum, Cornelia Mobius, Urban FietzekIp Chi Wang, Tae Mo Chung, Régina Helena Chueire, Carla Heloisa Cabral Moro, Alexis Schnitzler, Claire Delleci, Anne Laure Ferrapie, Marie Eve Isner-Horobeti, Dominic Perennou, Ching Man Leung, Michela Cosma, Carlo Caltagirone, Manuela Diverio, Paolo Girlanda, Giancarlo Ianeri, Marzia Millevolte, Franco Molteni, Jorge Hernandez Franco, Juan Francisco Gomez Hernandez, Sandra Quinones Aguilar, Laura Patricia de la Lanza Andrade, Raymond Rosales, Jeanne Flordelis, Dariusz Koziorowski, Anna Potulska, Monika Rudzinska, Eduarda Afonso, Ana Rolo Duarte, Svetlana Khatkova, Alexey Korenko, Dina Khasanova, Dmitry Okhabov, Elena Arefyeva, Denis Karpov, Andrey Korolev, Yi Chung Lee, Sen Wei Tsai, Jessica Tate, Thomas L. Davis, Cynthia Marciniak, Atul Patel

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Abstract

Objective: To describe the utility of a structured approach to assessing effectiveness following injection with botulinum toxin-A alongside physical therapies, within the first cycle of the Upper Limb International Spasticity-III (ULIS-III) study. Methods: ULIS-III (registered at clinicaltrials.gov as NCT02454803) is a large international, observational, longitudinal study of adults treated for upper-limb spasticity. It introduces novel methods for the structured evaluation of person-centred goal attainment alongside targeted standardized outcome measures: the Upper limb Spasticity Index, and the Upper Limb Spasticity Therapy Recording Schedule. Results: A total of 953/1,004 enrolled patients (95%) completed cycle 1. Mean overall goal attainment scaling (GAS) T scores were 49.8 (95% confidence interval 49.2-50.3; 67.1% of patients met their primary goal, with highest achievement rates for goals related to involuntary movement, (75.6%) and range of movement (74.4%). Standardized measures of spasticity, pain, involuntary movements, active and passive function, all improved significantly over the treatment cycle. Overall, 59.7% of patients saw a therapist following botulinum toxin-A injection. Interventions varied, as expected, with the set treatment goals. After controlling for concomitant therapies using the upper limb spasticity therapy recording schedule, significant differences in injection intervals (p< 0.001) were seen between the commercially-available botulinum toxin-A agents. Conclusion: The results of this study confirm the utility of the Upper Limb Spasticity Index and Upper Limb Spasticity Therapy Recording Schedule as a structured approach to capturing goal-setting, therapy inputs and outcomes assessment.

Original language	English (US)
Article number	jrm00133
Journal	Journal of Rehabilitation Medicine
Volume	53
Issue number	1
DOIs	https://doi.org/10.2340/16501977-2770
State	Published - Jan 2021

Keywords

Botulinum toxin-A
Goal attainment scaling
Physical therapy
Post-stroke spasticity
Stroke rehabilitation

ASJC Scopus subject areas

Physical Therapy, Sports Therapy and Rehabilitation
Rehabilitation

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10.2340/16501977-2770

Cite this

Turner-Stokes, L., Jacinto, J., Fheodoroff, K., Brashear, A., Maisonobe, P., Lysandropoulos, A., Ashford, S., Baguley, I., Aggarwal, A., Olver, J., Estell, J., Faux, S., Luk, E., Kotschet, K., Hughes, A., Nunan, R., Haslinger, B., Baum, P., Mobius, C., ... Patel, A. (2021). Assessing the effectiveness of upper-limb spasticity management using a structured approach to goal-setting and outcome measurement: First cycle results from the ulis-III study. Journal of Rehabilitation Medicine, 53(1), [jrm00133]. https://doi.org/10.2340/16501977-2770

Assessing the effectiveness of upper-limb spasticity management using a structured approach to goal-setting and outcome measurement : First cycle results from the ulis-III study. / Turner-Stokes, Lynne; Jacinto, Jorge; Fheodoroff, Klemens; Brashear, Allison; Maisonobe, Pascal; Lysandropoulos, Andreas; Ashford, Stephen; Baguley, Ian; Aggarwal, Arun; Olver, John; Estell, John; Faux, Steven; Luk, Edwin; Kotschet, Katya; Hughes, Andrew; Nunan, Rachael; Haslinger, Bernhard; Baum, Petra; Mobius, Cornelia; Fietzek, Urban; Chi Wang, Ip; Chung, Tae Mo; Chueire, Régina Helena; Moro, Carla Heloisa Cabral; Schnitzler, Alexis; Delleci, Claire; Ferrapie, Anne Laure; Isner-Horobeti, Marie Eve; Perennou, Dominic; Leung, Ching Man; Cosma, Michela; Caltagirone, Carlo; Diverio, Manuela; Girlanda, Paolo; Ianeri, Giancarlo; Millevolte, Marzia; Molteni, Franco; Franco, Jorge Hernandez; Hernandez, Juan Francisco Gomez; Aguilar, Sandra Quinones; de la Lanza Andrade, Laura Patricia; Rosales, Raymond; Flordelis, Jeanne; Koziorowski, Dariusz; Potulska, Anna; Rudzinska, Monika; Afonso, Eduarda; Duarte, Ana Rolo; Khatkova, Svetlana; Korenko, Alexey; Khasanova, Dina; Okhabov, Dmitry; Arefyeva, Elena; Karpov, Denis; Korolev, Andrey; Lee, Yi Chung; Tsai, Sen Wei; Tate, Jessica; Davis, Thomas L.; Marciniak, Cynthia; Patel, Atul.

In: Journal of Rehabilitation Medicine, Vol. 53, No. 1, jrm00133, 01.2021.

Research output: Contribution to journal › Article › peer-review

Turner-Stokes, L, Jacinto, J, Fheodoroff, K, Brashear, A, Maisonobe, P, Lysandropoulos, A, Ashford, S, Baguley, I, Aggarwal, A, Olver, J, Estell, J, Faux, S, Luk, E, Kotschet, K, Hughes, A, Nunan, R, Haslinger, B, Baum, P, Mobius, C, Fietzek, U, Chi Wang, I, Chung, TM, Chueire, RH, Moro, CHC, Schnitzler, A, Delleci, C, Ferrapie, AL, Isner-Horobeti, ME, Perennou, D, Leung, CM, Cosma, M, Caltagirone, C, Diverio, M, Girlanda, P, Ianeri, G, Millevolte, M, Molteni, F, Franco, JH, Hernandez, JFG, Aguilar, SQ, de la Lanza Andrade, LP, Rosales, R, Flordelis, J, Koziorowski, D, Potulska, A, Rudzinska, M, Afonso, E, Duarte, AR, Khatkova, S, Korenko, A, Khasanova, D, Okhabov, D, Arefyeva, E, Karpov, D, Korolev, A, Lee, YC, Tsai, SW, Tate, J, Davis, TL, Marciniak, C & Patel, A 2021, 'Assessing the effectiveness of upper-limb spasticity management using a structured approach to goal-setting and outcome measurement: First cycle results from the ulis-III study', Journal of Rehabilitation Medicine, vol. 53, no. 1, jrm00133. https://doi.org/10.2340/16501977-2770

Turner-Stokes, Lynne ; Jacinto, Jorge ; Fheodoroff, Klemens ; Brashear, Allison ; Maisonobe, Pascal ; Lysandropoulos, Andreas ; Ashford, Stephen ; Baguley, Ian ; Aggarwal, Arun ; Olver, John ; Estell, John ; Faux, Steven ; Luk, Edwin ; Kotschet, Katya ; Hughes, Andrew ; Nunan, Rachael ; Haslinger, Bernhard ; Baum, Petra ; Mobius, Cornelia ; Fietzek, Urban ; Chi Wang, Ip ; Chung, Tae Mo ; Chueire, Régina Helena ; Moro, Carla Heloisa Cabral ; Schnitzler, Alexis ; Delleci, Claire ; Ferrapie, Anne Laure ; Isner-Horobeti, Marie Eve ; Perennou, Dominic ; Leung, Ching Man ; Cosma, Michela ; Caltagirone, Carlo ; Diverio, Manuela ; Girlanda, Paolo ; Ianeri, Giancarlo ; Millevolte, Marzia ; Molteni, Franco ; Franco, Jorge Hernandez ; Hernandez, Juan Francisco Gomez ; Aguilar, Sandra Quinones ; de la Lanza Andrade, Laura Patricia ; Rosales, Raymond ; Flordelis, Jeanne ; Koziorowski, Dariusz ; Potulska, Anna ; Rudzinska, Monika ; Afonso, Eduarda ; Duarte, Ana Rolo ; Khatkova, Svetlana ; Korenko, Alexey ; Khasanova, Dina ; Okhabov, Dmitry ; Arefyeva, Elena ; Karpov, Denis ; Korolev, Andrey ; Lee, Yi Chung ; Tsai, Sen Wei ; Tate, Jessica ; Davis, Thomas L. ; Marciniak, Cynthia ; Patel, Atul. / Assessing the effectiveness of upper-limb spasticity management using a structured approach to goal-setting and outcome measurement : First cycle results from the ulis-III study. In: Journal of Rehabilitation Medicine. 2021 ; Vol. 53, No. 1.

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title = "Assessing the effectiveness of upper-limb spasticity management using a structured approach to goal-setting and outcome measurement: First cycle results from the ulis-III study",

abstract = "Objective: To describe the utility of a structured approach to assessing effectiveness following injection with botulinum toxin-A alongside physical therapies, within the first cycle of the Upper Limb International Spasticity-III (ULIS-III) study. Methods: ULIS-III (registered at clinicaltrials.gov as NCT02454803) is a large international, observational, longitudinal study of adults treated for upper-limb spasticity. It introduces novel methods for the structured evaluation of person-centred goal attainment alongside targeted standardized outcome measures: the Upper limb Spasticity Index, and the Upper Limb Spasticity Therapy Recording Schedule. Results: A total of 953/1,004 enrolled patients (95%) completed cycle 1. Mean overall goal attainment scaling (GAS) T scores were 49.8 (95% confidence interval 49.2-50.3; 67.1% of patients met their primary goal, with highest achievement rates for goals related to involuntary movement, (75.6%) and range of movement (74.4%). Standardized measures of spasticity, pain, involuntary movements, active and passive function, all improved significantly over the treatment cycle. Overall, 59.7% of patients saw a therapist following botulinum toxin-A injection. Interventions varied, as expected, with the set treatment goals. After controlling for concomitant therapies using the upper limb spasticity therapy recording schedule, significant differences in injection intervals (p< 0.001) were seen between the commercially-available botulinum toxin-A agents. Conclusion: The results of this study confirm the utility of the Upper Limb Spasticity Index and Upper Limb Spasticity Therapy Recording Schedule as a structured approach to capturing goal-setting, therapy inputs and outcomes assessment.",

keywords = "Botulinum toxin-A, Goal attainment scaling, Physical therapy, Post-stroke spasticity, Stroke rehabilitation",

author = "Lynne Turner-Stokes and Jorge Jacinto and Klemens Fheodoroff and Allison Brashear and Pascal Maisonobe and Andreas Lysandropoulos and Stephen Ashford and Ian Baguley and Arun Aggarwal and John Olver and John Estell and Steven Faux and Edwin Luk and Katya Kotschet and Andrew Hughes and Rachael Nunan and Bernhard Haslinger and Petra Baum and Cornelia Mobius and Urban Fietzek and {Chi Wang}, Ip and Chung, {Tae Mo} and Chueire, {R{\'e}gina Helena} and Moro, {Carla Heloisa Cabral} and Alexis Schnitzler and Claire Delleci and Ferrapie, {Anne Laure} and Isner-Horobeti, {Marie Eve} and Dominic Perennou and Leung, {Ching Man} and Michela Cosma and Carlo Caltagirone and Manuela Diverio and Paolo Girlanda and Giancarlo Ianeri and Marzia Millevolte and Franco Molteni and Franco, {Jorge Hernandez} and Hernandez, {Juan Francisco Gomez} and Aguilar, {Sandra Quinones} and {de la Lanza Andrade}, {Laura Patricia} and Raymond Rosales and Jeanne Flordelis and Dariusz Koziorowski and Anna Potulska and Monika Rudzinska and Eduarda Afonso and Duarte, {Ana Rolo} and Svetlana Khatkova and Alexey Korenko and Dina Khasanova and Dmitry Okhabov and Elena Arefyeva and Denis Karpov and Andrey Korolev and Lee, {Yi Chung} and Tsai, {Sen Wei} and Jessica Tate and Davis, {Thomas L.} and Cynthia Marciniak and Atul Patel",

note = "Funding Information: Person-centred goal attainment Supported by standardised assessment tools Funding Information: The authors thank all the investigators and patients who participated in this trial. We also thank Anita Chadha-Patel, PhD, of ACP Clinical Communications Ltd (Hertfordshire, UK) for providing medical writing support, which was funded by Ipsen (Paris, France) in accordance with Good Publication Practice guidelines. Financial support for manuscript preparation was also provided through the Northwick Park Charitable Funds. Funding. This work was supported by Ipsen Pharma. Publisher Copyright: {\textcopyright} 2021 Foundation for Rehabilitation Information. All rights reserved.",

year = "2021",

month = jan,

doi = "10.2340/16501977-2770",

language = "English (US)",

volume = "53",

journal = "Journal of Rehabilitation Medicine",

issn = "1650-1977",

publisher = "Foundation for Rehabilitation Information",

number = "1",

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TY - JOUR

T1 - Assessing the effectiveness of upper-limb spasticity management using a structured approach to goal-setting and outcome measurement

T2 - First cycle results from the ulis-III study

AU - Turner-Stokes, Lynne

AU - Jacinto, Jorge

AU - Fheodoroff, Klemens

AU - Brashear, Allison

AU - Maisonobe, Pascal

AU - Lysandropoulos, Andreas

AU - Ashford, Stephen

AU - Baguley, Ian

AU - Aggarwal, Arun

AU - Olver, John

AU - Estell, John

AU - Faux, Steven

AU - Luk, Edwin

AU - Kotschet, Katya

AU - Hughes, Andrew

AU - Nunan, Rachael

AU - Haslinger, Bernhard

AU - Baum, Petra

AU - Mobius, Cornelia

AU - Fietzek, Urban

AU - Chi Wang, Ip

AU - Chung, Tae Mo

AU - Chueire, Régina Helena

AU - Moro, Carla Heloisa Cabral

AU - Schnitzler, Alexis

AU - Delleci, Claire

AU - Ferrapie, Anne Laure

AU - Isner-Horobeti, Marie Eve

AU - Perennou, Dominic

AU - Leung, Ching Man

AU - Cosma, Michela

AU - Caltagirone, Carlo

AU - Diverio, Manuela

AU - Girlanda, Paolo

AU - Ianeri, Giancarlo

AU - Millevolte, Marzia

AU - Molteni, Franco

AU - Franco, Jorge Hernandez

AU - Hernandez, Juan Francisco Gomez

AU - Aguilar, Sandra Quinones

AU - de la Lanza Andrade, Laura Patricia

AU - Rosales, Raymond

AU - Flordelis, Jeanne

AU - Koziorowski, Dariusz

AU - Potulska, Anna

AU - Rudzinska, Monika

AU - Afonso, Eduarda

AU - Duarte, Ana Rolo

AU - Khatkova, Svetlana

AU - Korenko, Alexey

AU - Khasanova, Dina

AU - Okhabov, Dmitry

AU - Arefyeva, Elena

AU - Karpov, Denis

AU - Korolev, Andrey

AU - Lee, Yi Chung

AU - Tsai, Sen Wei

AU - Tate, Jessica

AU - Davis, Thomas L.

AU - Marciniak, Cynthia

AU - Patel, Atul

N1 - Funding Information: Person-centred goal attainment Supported by standardised assessment tools Funding Information: The authors thank all the investigators and patients who participated in this trial. We also thank Anita Chadha-Patel, PhD, of ACP Clinical Communications Ltd (Hertfordshire, UK) for providing medical writing support, which was funded by Ipsen (Paris, France) in accordance with Good Publication Practice guidelines. Financial support for manuscript preparation was also provided through the Northwick Park Charitable Funds. Funding. This work was supported by Ipsen Pharma. Publisher Copyright: © 2021 Foundation for Rehabilitation Information. All rights reserved.

PY - 2021/1

Y1 - 2021/1

N2 - Objective: To describe the utility of a structured approach to assessing effectiveness following injection with botulinum toxin-A alongside physical therapies, within the first cycle of the Upper Limb International Spasticity-III (ULIS-III) study. Methods: ULIS-III (registered at clinicaltrials.gov as NCT02454803) is a large international, observational, longitudinal study of adults treated for upper-limb spasticity. It introduces novel methods for the structured evaluation of person-centred goal attainment alongside targeted standardized outcome measures: the Upper limb Spasticity Index, and the Upper Limb Spasticity Therapy Recording Schedule. Results: A total of 953/1,004 enrolled patients (95%) completed cycle 1. Mean overall goal attainment scaling (GAS) T scores were 49.8 (95% confidence interval 49.2-50.3; 67.1% of patients met their primary goal, with highest achievement rates for goals related to involuntary movement, (75.6%) and range of movement (74.4%). Standardized measures of spasticity, pain, involuntary movements, active and passive function, all improved significantly over the treatment cycle. Overall, 59.7% of patients saw a therapist following botulinum toxin-A injection. Interventions varied, as expected, with the set treatment goals. After controlling for concomitant therapies using the upper limb spasticity therapy recording schedule, significant differences in injection intervals (p< 0.001) were seen between the commercially-available botulinum toxin-A agents. Conclusion: The results of this study confirm the utility of the Upper Limb Spasticity Index and Upper Limb Spasticity Therapy Recording Schedule as a structured approach to capturing goal-setting, therapy inputs and outcomes assessment.

AB - Objective: To describe the utility of a structured approach to assessing effectiveness following injection with botulinum toxin-A alongside physical therapies, within the first cycle of the Upper Limb International Spasticity-III (ULIS-III) study. Methods: ULIS-III (registered at clinicaltrials.gov as NCT02454803) is a large international, observational, longitudinal study of adults treated for upper-limb spasticity. It introduces novel methods for the structured evaluation of person-centred goal attainment alongside targeted standardized outcome measures: the Upper limb Spasticity Index, and the Upper Limb Spasticity Therapy Recording Schedule. Results: A total of 953/1,004 enrolled patients (95%) completed cycle 1. Mean overall goal attainment scaling (GAS) T scores were 49.8 (95% confidence interval 49.2-50.3; 67.1% of patients met their primary goal, with highest achievement rates for goals related to involuntary movement, (75.6%) and range of movement (74.4%). Standardized measures of spasticity, pain, involuntary movements, active and passive function, all improved significantly over the treatment cycle. Overall, 59.7% of patients saw a therapist following botulinum toxin-A injection. Interventions varied, as expected, with the set treatment goals. After controlling for concomitant therapies using the upper limb spasticity therapy recording schedule, significant differences in injection intervals (p< 0.001) were seen between the commercially-available botulinum toxin-A agents. Conclusion: The results of this study confirm the utility of the Upper Limb Spasticity Index and Upper Limb Spasticity Therapy Recording Schedule as a structured approach to capturing goal-setting, therapy inputs and outcomes assessment.

KW - Botulinum toxin-A

KW - Goal attainment scaling

KW - Physical therapy

KW - Post-stroke spasticity

KW - Stroke rehabilitation

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Assessing the effectiveness of upper-limb spasticity management using a structured approach to goal-setting and outcome measurement: First cycle results from the ulis-III study

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