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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-004369-15 | EudraCT Number |
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The purpose of the protocol is to assess the longitudinal attainment of person-centered and function related goals of patients who receive AbobotulinumtoxinA (aboBoNT-A) injections for adult lower limb spasticity over a period of 16 months.
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| Measure | Description | Time Frame |
|---|---|---|
| Subject centred Goal Attainment Scaling Leg T score (GASleg T) | Mean individual GASleg T score. Goal attainment for each goal will be recorded clinically on a 5-point verbal rating scale (range -2 to +2) and goal scores combined to give an aggregated T score using a standard formula (GASleg T score). Range meaning is -2 = much less than expected and +2 = much more than expected. The subject and/or caregiver to identify the main goal areas and establish agreed person centred and function related goals guided by GASleg (usually one primary and up to two secondary goals) at each visit. Goal attainment will be evaluated at the routine follow up visit. Goals will be redefined and/or newly set at each injection visit or as per routine practice if further injections are not given. Goals will be SMART [Specific, measurable, attainable, relevant, and time-based] | 16 months |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle tone | Muscle tone will be evaluated using the Modified Ashworth Scale (MAS) /Tardieu Scale according to clinical practice. The MAS is a six point scale (with available scores of 0, 1, 1+, 2, 3 and 4) reporting changes in muscle tone during muscle flexion or extension. Tardieu scale quantifies muscle spasticity by assessing the response of the muscle to stretch applied at specified velocities. It can therefore broadly differentiate between the two key factors explaining resistance to passive stretch, namely contracture (non-neural factors) and spasticity (neural factors). |
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Inclusion Criteria:
Exclusion Criteria:
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Adults with a primary diagnosis of unilateral adult lower limb nonprogressive focal spasticity
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rancho Los Amigos National Rehabilitation Center (RLANRC) - Neurology | Downey | California | 90242 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41449804 | Derived | Esquenazi A, Zorowitz RD, Ashford S, Jacinto J, Beneteau M, Maisonobe P, Hannes C, Sandars S. Achieving treatment goals with repeated injections of botulinum toxin in adults with leg spasticity. Curr Med Res Opin. 2025 Dec;41(12):2277-2285. doi: 10.1080/03007995.2025.2606555. Epub 2025 Dec 25. | |
| 39571744 | Derived |
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| 16 months |
| Severity of different aspects of impairment | Severity of different aspects of impairment in subjects with neurological injury will be evaluated using the Lower Limb Spasticity adapted Neurological Impairment Scale. (LLS-NIS) Higher LLS-NIS scores indicate more severe impairment (LLS-NIS). Higher LLS-NIS scores indicate more severe impairment. | 16 months |
| Total dose injected per cycle | 16 months |
| Report muscles injected | 16 months |
| Report dose per muscle | 16 months |
| Assess correlations of subject centered goals | Correlations of subject centred goals and related standardised rating scales will be assessed using GASleg and standardised outcome measures selected according to the goals for treatment. | 16 months |
| Evolution of Quality of Life | Assess the evolution of QoL at each visit based on the EQ-5D-5L and the QoL element of LegA. This is a descriptive scale that covers 5 dimensions: mobility, self-care, usual activities,pain/discomfort and anxiety/depression. the scale consist of 5 levels, where level one corresponds to "no problems" and level 5 corresponds to "extreme problem". | 16 months |
| MedStar National Rehabilitation Hospital |
| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| Kansas City Bone and Joint Clinic, P.A. (KCBJ) - Overland Pa | Leawood | Kansas | 10701 | United States |
| Neurology Center of NE,PC - Neurology | Foxborough | Massachusetts | 02035 | United States |
| Beaumont Hospital, Grosse Pointe - Neurology | Grosse Pointe | Michigan | 48230 | United States |
| Yeshiva University - Albert Einstein College of Medicine - Montefiore Medical Center (MMC) - Neurology | The Bronx | New York | 10467 | United States |
| Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | 27157-0001 | United States |
| Dayton Center for Neurological Disorders | Centerville | Ohio | 45459 | United States |
| Riverhills Healthcare | Cincinnati | Ohio | 45212 | United States |
| OrthoNeuro | Columbus | Ohio | 43235 | United States |
| Good Shepherd Rehabilitation Hospital - Neurology | Allentown | Pennsylvania | 18103 | United States |
| MossRehab - Einstein Medical Center | Elkins Park | Pennsylvania | 19027 | United States |
| Rehabilitation Associates - Neurology | Paoli | Pennsylvania | 19301 | United States |
| University of Texas Southwestern | Dallas | Texas | 75390 | United States |
| The University of Utah School of Medicine | Salt Lake City | Utah | 84132-0002 | United States |
| Medical College of Wisconsin - Froedtert Hospital | Milwaukee | Wisconsin | 53226-3522 | United States |
| Princess Alexandra Hospital | Ipswich | QLD 4102 | Australia |
| Royal Prince Alfred Hospital | Rozelle | 2039 | Australia |
| Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto (HCFMRP) - Neurology | Ribeirão Preto | 14049-900 | Brazil |
| Hospital de Base de São José do Rio Preto at Centro Integrado de Pesquisa (CIP) - Neurology | São José do Rio Preto | 15091-240 | Brazil |
| Glenrose Rehabilitation Hospital | Edmonton | T5G 0B7 | Canada |
| River Valley Health - Stan Cassidy Foundation - Stan Cassidy | Fredericton | E3B0C7 | Canada |
| McGill University Health Center | Montreal | H3G 1A4 | Canada |
| CHU - Hôpital Pellegrin - Neurologie | Bordeau | 33000 | France |
| CHU RAYMOND POINCARE - Neurology | Garches | 92380 | France |
| Centre Hospitalier Regional Universitaire (CHRU) de Lille - Hopital Pierre Swynghedauw - Neurology | Lille | 59037 | France |
| Höpital Sainte-Marie - Neurology | Paris | 75014 | France |
| Centre Hospitalier Universitaire De Reims - Hopital Maison B | Reims | 51092 | France |
| Pole Saint Helier | Rennes | 35043 | France |
| Neurologie und Psychosomatik am Wittenbergplatz | Berlin | 10787 | Germany |
| Universitätsklinikum Erlangen | Erlangen | Germany |
| Medizinische Hochschule Hannover - Neurology Neurologische Poliklinik | Hanover | 30625 | Germany |
| Universitätsklinikum/Neurologie | Lübeck | Germany |
| Neurologische Klinik und Poliklinik | Würzburg | Germany |
| Università Degli studi della Campania - Luigi Vanvitelli - Neurologica | Naples | 80131 | Italy |
| Istituto Scientifico di Riabilitazione di Veruno, Fondazione | Novara | 28010 | Italy |
| PO Villa Sofia, AO Ospedali Riuniti Villa Sofia-Cervello | Palermo | 90146 | Italy |
| AO S.Camillo-Forlanini | Roma | 00152 | Italy |
| Universita degli Studi di Verona - Centro di Ricerca in Riabilitazione Neuromotoria e Cognitiva (CRRNC) - Neurology | Verona | 37134 | Italy |
| SP ZOZ Szpital Uniwersytecki w Krakowie | Krakow | 31503 | Poland |
| Wojew. Wielospecjalistyczne Centrum Onkologii i Traumatologii im.M.Kopernika w Lodzi | Lodz | 93-513 | Poland |
| Instytut Psychiatrii i Neurologii | Warsaw | 02957 | Poland |
| Mazowiecki Szpital Brodnowski w Warszawie Sp. z o.o. Brodnowskie Centrum Kliniczne Poliklinika Brodnowskiego Centrum Klinicznego | Warsaw | 03-242 | Poland |
| Wojewódzki Szpital Specjalistyczny we Wrocławiu | Wroclaw | 51-124 | Poland |
| Regional state budget health institution "City Hospital № 5" | Barnaul | 656045 | Russia |
| SAHI Interregional Clinical Diagnostic Center | Kazan' | Russia |
| National Medical Research Treatment and Rehabilitation Center of the Ministry of Health of Russia | Moscow | 125367 | Russia |
| Bekhterev National Research Medical Center for Psychiatry | Saint Petersburg | 192019 | Russia |
| Pavlov First Saint-Petersburg State Medical University - Neurology | Saint Petersburg | 197022 | Russia |
| Federal State Budgetary Institution "All-Russian Center for Emergency Medicine and Medical Radiology named after A.M. Nikiforov" of the EMERCOM of Russia | Saint Petersburg | 197082 | Russia |
| FGBOU VO "Ural state medical university" | Yekaterinburg | 620028 | Russia |
| Esquenazi A, Zorowitz RD, Ashford S, Beneteau M, Maisonobe P, Hannes C, Jacinto J; AboLiSh Study Group. Longitudinal Goal Attainment With Repeat Injections of AbobotulinumtoxinA in Adults With Lower Limb Spasticity: Results From a Prospective Observational Study. Arch Phys Med Rehabil. 2025 Jun;106(6):894-901. doi: 10.1016/j.apmr.2024.10.017. Epub 2024 Nov 20. |
| 37794845 | Derived | Esquenazi A, Zorowitz RD, Ashford S, Maisonobe P, Page S, Jacinto J. Clinical presentation of patients with lower limb spasticity undergoing routine treatment with botulinum toxin: baseline findings from an international observational study. J Rehabil Med. 2023 Oct 5;55:jrm4257. doi: 10.2340/jrm.v55.4257. |