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The primary purpose for this study is to understand the effect of botulinum toxin as a treatment integrated in the management of spasticity (stiffness) in the arm and/or hand, arising from any neurological condition. The study will look at the types of goals that people choose for treatment, and the extent to which these are achieved in different individuals.
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| Measure | Description | Time Frame |
|---|---|---|
| Patient centred goal attainment will be assessed using the cumulated Goal Attainment Scale Total Score (GAS T score). | Goal attainment will be recorded on a five point numerical scale (range -2 to +2) and goal scores combined to give an aggregated T score. | From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection) |
| Measure | Description | Time Frame |
|---|---|---|
| To document the baseline patient characteristics and disease history. | Muscle tone will be evaluated using the Modified Ashworth Scale (MAS). Severity of different aspects of impairment in patients with neurological damage will be evaluated using the Upper Limb Spasticity Neurological Impairment Scale (ULS-NIS) recorded for both upper limbs. | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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Patient suffering from upper limb spasticity (ULS) seen in clinic, hospital and/or rehabilitation centers.
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Design Neuroscience | Doral | Florida | 33172 | United States | ||
| Rehabilitation Institute of Chicago |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34932284 | Derived | Khat'kova SE, Baikova A, Maisonobe P, Khasanova DR. [Impact of integrated upper limb spasticity management including repeat botulinum toxin type A (BoNT-A) injections on patient-centred goal attainment in real-life practice: results from the prospective, observational Upper Limb International Spasticity cohort study (ULIS-III) in a Russian subpopulation]. Zh Nevrol Psikhiatr Im S S Korsakova. 2021;121(11):39-48. doi: 10.17116/jnevro202112111139. Russian. | |
| 33206198 |
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| To document the clinical management of the upper limb spasticity. | BoNT-A injection practices, concomitant drug and non-drug therapies. | From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection) |
| Patient centred goal attainment by goal area. | Assessed using the cumulated GAS T score of all goals assessed within each goal area. | From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection) |
| Evolution of goal changes across the study will be recorded alongside changes from baseline in the standardised outcome measures. | From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection) |
| Assessment of the correlations between patient centred goals and related standardised rating scales. | Using Goal Attainment Scaling Evaluation of Intensity (GASeous) and standardised outcome measures. | From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection) |
| Evaluation of change from baseline in the four domains of Disability Assessment Scale (DAS) as well as in the Principal Target of Treatment (PTT). | The DAS will be used at each visit to determine the extent of functional impairment in four domains: hygiene, dressing, limb position and pain. Impairment is assessed on a four point scale (range 0 to 3, where 0=no disability, and 3=severe disability). The PTT will be defined at each visit, based on one of the four DAS domains. | From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection) |
| Evolution of quality of life | Assessed at each visit in a subpopulation of English-native speaker patients in Anglophone countries based on two different quality of life instruments, EuroQol 5 Dimensions, 5 levels (EQ 5D 5L) and Spasticity Related Quality of Life Tool (SQoL 6D). | From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection) |
| Health economic | Health economic analysis will include changes in concomitant treatments, changes in patient employment status, maintenance of health care (by nurse, caregiver etc) and utility data derived from EQ-5D 5L, DAS, GAS and SQoL-6D. | From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection) |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Kansas City Bone & Joint Clinic | Overland Park | Kansas | 66211 | United States |
| Wake Forest School of Medicine | Winston-Salem | North Carolina | 27157 | United States |
| Vanderbilt University | Nashville | Tennessee | 37235 | United States |
| Epworth Rehabilitation Camberwell | Camberwell | 03124 | Australia |
| St Vincent's Hospital | Darlinghurst | Australia |
| Austin Health Hospital | Heidelberg | VIC 3084 | Australia |
| Liverpool Brain Injury Rehabilitation Unit | Liverpool | NSW2170 | Australia |
| Royal Melbourne Hospital | Parkville | 3052 | Australia |
| Prince of Wales Hospital | Randwick | 02232 | Australia |
| RPAH | Sydney | 02050 | Australia |
| Westmead Hospital | Westmead | NWS 2145 | Australia |
| Princess Alexandra Hospital | Woolloongabba | QLD 4102 | Australia |
| Gaitlal-Klinik Hermagor | Hermagor | 09620 | Austria |
| Hospital de Clinicas da UFPR | Curitiba | Brazil |
| Fundacao Faculdade Regional de Medicina | São José do Rio Preto | 15091-240 | Brazil |
| Hospital dos Clinicas Universitaria de Sao Paulo | São Paulo | 05403-000 | Brazil |
| Centre Régional de Rééducation et Réadaptation Fonctionnelle | Angers | France |
| CHU Pellegrin | Bordeaux | France |
| Hôpital Raymond Poincaré | Garches | France |
| CHU Grenoble Hôpital Sud | Grenoble | France |
| Institut Universitaire de Réadaptation de Clémenceau | Strasbourg | France |
| Universitaets-Klinikum Erlangen | Erlangen | Germany |
| Universitaetsklinikum Leipzig | Leipzig | Germany |
| Klinikum rechts der Isar der Technischen Universitaet Muenchen | Munich | Germany |
| Schoen Klinik Muenchen Schwabing | Munich | Germany |
| Universitaetsklinikum Wuerzburg | Würzburg | Germany |
| Tung Wah Hospital | Hong Kong | Hong Kong |
| Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona | Ancona | Italy |
| Azienda Ospedaliero Universitaria Consorziale Policlinico | Bari | Italy |
| Ospedale Valduce - Villa Beretta | Costa Masnaga | Italy |
| Azienda Ospedaliero Universitaria di Ferrara | Ferrara | Italy |
| Azienda Ospedaliero Universitaria Policlinico "G Martino" | Messina | Italy |
| Fondazione Santa Lucia, I.R.C.C.S. | Roma | Italy |
| Fondazione Don Carlo Gnocchi Onlus | Sarzana | Italy |
| Hospital Angeles Clinica Londres | Mexico City | 06700 | Mexico |
| Grupo Torre Medica | México | Mexico |
| National Institute of Neurology/Rehabilitation | México | Mexico |
| Rehabilitation Centre | Querétaro | Mexico |
| Perpetual Succour Hospital | Cebu City | Philippines |
| Metropolitan Medical Center | Manila | Philippines |
| Academy of Neurology | Krakow | Poland |
| Bonacha | Warsaw | Poland |
| Public Hospital Wojewodzki | Warsaw | Poland |
| Alcoitao Rehabilitation Centre | Alcoitão | Portugal |
| Hospital de Faro | Faro | Portugal |
| Hospital Egas Moniz | Lisbon | Portugal |
| Regional State Budgetary Healthcare Institution "City Hospital N°5" | Barnaul | Russia |
| Interregional Cinical and Diagnostic Centre | Kazan' | Russia |
| Kemerovo Regional Clinical Hospital | Kemerovo | Russia |
| Krasnoyarsks State Medical University | Krasnoyarsk | Russia |
| Federal State Hospital for Treatment and Rehabilitation | Moscow | Russia |
| Federal State Budgetary Institution | Saint Petersburg | Russia |
| Pavlov First Saint-Petersburg State Medical University | Saint Petersburg | Russia |
| China Medical University Hospital | Taichung | Taiwan |
| Veteran General Hospital | Taipei | Taiwan |
| Derived |
| Turner-Stokes L, Jacinto J, Fheodoroff K, Brashear A, Maisonobe P, Lysandropoulos A, Ashford S; Upper Limb International Spasticity-III (ULIS-III) study group. 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. J Rehabil Med. 2021 Jan 1;53(1):jrm00133. doi: 10.2340/16501977-2770. |
| 27315835 | Derived | Turner-Stokes L, Ashford S, Jacinto J, Maisonobe P, Balcaitiene J, Fheodoroff K. Impact of integrated upper limb spasticity management including botulinum toxin A on patient-centred goal attainment: rationale and protocol for an international prospective, longitudinal cohort study (ULIS-III). BMJ Open. 2016 Jun 17;6(6):e011157. doi: 10.1136/bmjopen-2016-011157. |