To Document the Effectiveness of BoNT-A Injection in Adult Subjects With Upper Limb Spasticity Following Stroke
NCT ID: NCT01020500
Last Updated: 2020-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
469 participants
OBSERVATIONAL
2010-01-31
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* At least a 12-week interval between the last injection (BoNT-A or BoNT-B) and inclusion
* Decision already been agreed to inject BoNT-A
* Agreement with the subject on goal setting
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Ipsen
INDUSTRY
Responsible Party
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Principal Investigators
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Ipsen Study Director
Role: STUDY_DIRECTOR
Ipsen
Locations
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Rankin Park (site 036006)
Newcastle, , Australia
Northshore Private Hospital (site 036003)
Sydney, , Australia
Royal Prince Alfred Hospital (site 036005)
Sydney, , Australia
Ryde Rehabilitation Center (site 036002)
Sydney, , Australia
St Joseph's Hospital (site 036004)
Sydney, , Australia
St Vincent's Hospital (site 036001)
Sydney, , Australia
NÖ LKH Grimmenstein-Hochegg (site 040002)
Grimmenstein, , Austria
Gaital-Kliniken Hermagor (site 040001)
Hermagor, , Austria
Revalidatieziekenhuis Hof ter Schelde, August Vermeylenlaan 6 (site 056001)
Antwerp, , Belgium
AZ St. Jan, Ruddershove 10, (site 056002)
Bruges, , Belgium
UCL St. Luc Département de médecine, physique et de readaptation motrice, Avenue Hippocrate 10 (site 056004)
Brussels, , Belgium
Cliniques Universitaires UCL de Mont-Godinne, Avenue Dr. G. Therasse (site 056003)
Yvoir, , Belgium
Rehabilitation Unit, Tung Wah Hospital, 12 Po Yan Street, Sheung Wan (site 344001)
Hong Kong, , China
Faculty Hospital Brno (site 203002)
Brno, , Czechia
Hospital Pardubice, Neurology dept. (site 203001)
Pardubice, , Czechia
Aarhus University Hospital, Neurolog avd.F-NEU-Cent (Site 208001)
Aarhus, , Denmark
Herlev Hospital, Herlev Ringvej (Site 208004)
Copenhagen, , Denmark
Neurologisk afdeling N, Amtssygehuset i Glostrup (Site 208003)
Glostrup Municipality, , Denmark
Department of Physical and Rehabilitation Medicine/Central Hospital of Central Finland (Site 246005)
Jyväskylä, , Finland
Invalidförbundets Rehabiliteringscenter i Lappland (Site 246004)
Rovaniemi, , Finland
Neurologiska Polikliniken, Tampere University Hospital (site 246001)
Tampere, , Finland
Centre Régional de Rééducation et Réadaptation fonctionnelle (site 250008)
Angers, , France
Centre de Rééducation Fonctionnelle du Mont Veyrier Rééducation fonctionnelle (site 250021)
Argonay, , France
Hôpital Jean Minjoz/Méd.physique réadaptation (site 250016)
Besançon, , France
Hôpital Pellegrin/Rééducation fonctionnelle (site 250012)
Bordeaux, , France
Centre Médecine Physique Réadaptation/Rééducation Neurologique (site 250013)
Coubert, , France
Hopital Albert Chenevier/Neurologie, (site 250010)
Créteil, , France
CHU Hôpital SUD/Institut de Rééducation (site 250007)
Échirolles, , France
Hôpital Raymond Poincaré/Rééducation neurologique (site 250002)
Garches, , France
CHRU Lille/Rééducation Neurologique (site 250018)
Lille, , France
Hopital Jean Rebeyrol/Médecine Physique et de Réadaptation (site 250006)
Limoges, , France
Centre Médico-Chirurgical de Réadaptation des Massues (Site 250005)
Lyon, , France
Hôpital Timone Adultes/Rééducation fonctionnelle (site 250020)
Marseille, , France
CHU Lapeyronie /Rééducation fonctionnelle (site 250014)
Montpellier, , France
CHU de Nantes/Médecine physique et de réadaptation neurologique (site 250017)
Nantes, , France
Médecine Physique et de Réadaptation Fondation Hospitalière Sainte Marie (site 250001)
Paris, , France
Hôpital Sébastopol/Rééducation Fonctionnelle (site 250004)
Reims, , France
Hôpital Pontchaillou/Rééducation Fonctionnelle (site 250003)
Rennes, , France
Hôpital Hautepierre/Rééducation fonctionnellev (site 250011)
Strasbourg, , France
Hôpital Rangueil/Médecine Physique réadaptation (site 250015)
Toulouse, , France
Sächs. KH Neurologie, Hufelandstr. 15 (site 276006)
Arnsdorf, , Germany
Kinik für Neurologie Paracelsusring 6a (site 276003)
Beelitz, , Germany
NRZ Neurologisches Rehazentrum (site 276004) Muldentalweg 1
Bennewitz, , Germany
Praxis für Neurologie, Dalberger Str. 6 (site 276007)
Frankfurt, , Germany
Kliniken der Medizinischen Hochschule (Neurologische Klinik), Carl-Neuberg-Str. 1 (site 276005)
Hanover, , Germany
Praxis für Neurologie Mittelstr. 4 (site 276008)
Mannheim, , Germany
Paracelsus Klinik Werdauer Str. 68 (site 276002)
Zwickau, , Germany
Clinica di Neuroriabilitatione - Az. Osp. Univ. Ospedali Riuniti (site 380004)
Ancona, , Italy
Azienda Ospedaliera Universitaria (site 380012)
Ferrara, , Italy
Ospedale Valduce, Costa Masnaga (site 380001)
Lecco, , Italy
Laboratorio analisi del Movimento U.O.R.R.F. -Ospedale Santa Corona (site 380002)
Pietra Ligure, , Italy
Ospedale Cisanello (site 380010)
Pisa, , Italy
Ospedale S. Bartolomeo (site 380005)
Sarzana, , Italy
Hospital Kuala Lumpur (site 458002)
Kuala Lumpur, , Malaysia
Universiti Malaya Medical Center/Department of Neurology / Department of Rehabilitation Medicine (site 458001)
Kuala Lumpur, , Malaysia
Colonia Ladrón de Guevara (Site 484001)
Guadalajara, Jalisco, Mexico
Angeles del Pedregal (Site 484002)
México, , Mexico
Perpetual Succour Hospital (site 608002)
Cebu City, , Philippines
Metropolitan Medical Center (site 608001)
Manila, , Philippines
Centro de Medicina de Reabilitação de Alcoitão (site 620001)
Alcabideche, , Portugal
Centro Hospitalar de Coimbra - Quinta dos Vales (site 620005)
Coimbra, , Portugal
Hospital Distrital de Faro (site 620004)
Faro, , Portugal
Hospital Egas Moniz, Centro Hospitalar Lisboa Ocidental (site 620003)
Lisbon, , Portugal
Hospital Geral de Santo Antonio, Centro Hospitalar do Porto (site 620002)
Porto, , Portugal
Municipal health care institution "City clinical hospital #3" (site 643006)
Chelyabinsk, , Russia
State Institution "Interregional clinical diagnostic centre" (site 643002)
Kazan', , Russia
Municipal health care institution "City hospital #2 "Krasnodar Multidisciplinary medical diagnostic association" (site 643004)
Krasnodar, , Russia
State Educational Institution of high professional education "Krasnoyarsk State Medical Academy of Roszdrav" (site 643007)
Krasnoyarsk, , Russia
Federal State Institution "Medical Rehabilitation Centre of Roszdrav" (site 643001)
Moscow, , Russia
State Novosibirsk Regional Clinical Diagnostic Centre (site 643005)
Novosibirsk, , Russia
State Educational Institution of high professional education "St-Peterbusrg state medical university named after I.P. Pavlov of Roszdrav" (site 643003)
St-Peterburg, , Russia
Singapore General Hospital, Department of Rehabilitation Medicine (site 702002)
Singapore, , Singapore
Tan Tock Seng Hospital/TTSH Rehabilitation Centre (site 702001)
Singapore, , Singapore
Catholic University Daejeon St. Mary's Hospital, Daeheung-dong, Jung-gu, (site 410004)
Daejeon, , South Korea
Inha University Hospital, #7-206 Shinheungdong-ga,Jjung-gu (site 410006)
Incheon, , South Korea
Samsung Medical Center, #50 Ilwon-dong, Gangnam-gu (site 410002)
Seoul, , South Korea
Dept. for Rehabilitation Asan Medical Center (site 410005)
Seoul, , South Korea
Dept. of Rehabilitation Seoul National University Bundang Hospital (site 410003)
Seoul, , South Korea
Dept. of Rehabilitation Yonsei University Severance Hospital (site 410001)
Seoul, , South Korea
Hospital La Paz / Servicio de Rehabilitación (site 724006)
Madrid, , Spain
Hospital Morales Meseguer / Servicio de Rehabilitación (site 724005)
Murcia, , Spain
Hospital Marqués de Valdecilla/ Servicio de Rehabilitación (site 724009)
Santander, , Spain
Hospital Universitario La Fe (Site 724003)
Valencia, , Spain
Mälarsjukhuset, Dept. Of Neurology (site 752001)
Eskilstuna, , Sweden
Dept. Of Neurology, Nyköping Hospital (site 752002)
Nyköping, , Sweden
Östersunds Rehab Centrum (site 752004)
Östersund, , Sweden
Läkarhuset Odenplan, Neuro Unit (site 752003)
Stockholm, , Sweden
China Medical University Hospital, Department of Physical Medicine & Rehabilitation (site 158002)
Taichung, , Taiwan
Veteran General Hospital (site 158001)
Taipei, , Taiwan
King Chulalongkorn Memorial Hospital/Department of Rehabilitation Medicine (site 764002)
Bangkok, , Thailand
Siriraj Hospital/Department of Rehabilitation Medicine (site 764001)
Bangkok, , Thailand
Dewsbury District Hospital (site 826004)
Dewsbury, , United Kingdom
Medway Maritime Hospital (site 826002)
Gillingham, , United Kingdom
Lincoln County Hospital (site 826001)
Lincoln, , United Kingdom
Regional Rehabilitation Unit, Northwick Park Hospital (site 826006)
Middlesex, , United Kingdom
West Midlands/Rehabilitation Centre (826005)
Plymouth, , United Kingdom
Countries
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References
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Fheodoroff K, Ashford S, Jacinto J, Maisonobe P, Balcaitiene J, Turner-Stokes L. Factors influencing goal attainment in patients with post-stroke upper limb spasticity following treatment with botulinum toxin A in real-life clinical practice: sub-analyses from the Upper Limb International Spasticity (ULIS)-II Study. Toxins (Basel). 2015 Apr 8;7(4):1192-205. doi: 10.3390/toxins7041192.
Turner-Stokes L, Fheodoroff K, Jacinto J, Maisonobe P. Results from the Upper Limb International Spasticity Study-II (ULISII):a large, international, prospective cohort study investigating practice and goal attainment following treatment with botulinum toxin A in real-life clinical management. BMJ Open. 2013 Jun 20;3(6):e002771. doi: 10.1136/bmjopen-2013-002771.
Turner-Stokes L, Fheodoroff K, Jacinto J, Maisonobe P, Zakine B. Upper limb international spasticity study: rationale and protocol for a large, international, multicentre prospective cohort study investigating management and goal attainment following treatment with botulinum toxin A in real-life clinical practice. BMJ Open. 2013 Mar 18;3(3):e002230. doi: 10.1136/bmjopen-2012-002230.
Other Identifiers
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Y-79-52120-138
Identifier Type: -
Identifier Source: org_study_id