To Document the Effectiveness of BoNT-A Injection in Adult Subjects With Upper Limb Spasticity Following Stroke
- Conditions
- Muscle Spasticity
- Registration Number
- NCT01020500
- Lead Sponsor
- Ipsen
- Brief Summary
The purpose of the study is to assess the responder rate as defined by the achievement of the primary goal from the Goal Attainment Scale following one BoNT-A injection cycle in accordance with routine practices.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 469
- Upper limb spasticity following stroke
- 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
- Contraindications to any BoNT-A preparations
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Responder rate as defined by the achievement of the primary goal from the Goal Attainment Scale (GAS) following one BoNT-A injection cycle in accordance with routine practices Around 3 to 5 months post injection
- Secondary Outcome Measures
Name Time Method Global assessment of benefits by both the investigator and the subject (or guardian) Around 3 to 5 months post injection Overall attainment of the treatment goals using the GAS T score Around 3 to 5 months post injection Result of standardized outcome measures (e.g., muscle tone reduction, pain scores, arm function test) Around 3 to 5 months post injection
Trial Locations
- Locations (96)
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
Revalidatieziekenhuis Hof ter Schelde, August Vermeylenlaan 6 (site 056001)
🇧🇪Antwerpen, Belgium
Herlev Hospital, Herlev Ringvej (Site 208004)
🇩🇰Copenhagen, Denmark
UCL St. Luc Département de médecine, physique et de readaptation motrice, Avenue Hippocrate 10 (site 056004)
🇧🇪Bruxelles, Belgium
Cliniques Universitaires UCL de Mont-Godinne, Avenue Dr. G. Therasse (site 056003)
🇧🇪Yvoir, Belgium
Neurologisk afdeling N, Amtssygehuset i Glostrup (Site 208003)
🇩🇰Glostrup, Denmark
St Vincent's Hospital (site 036001)
🇦🇺Sydney, Australia
NÖ LKH Grimmenstein-Hochegg (site 040002)
🇦🇹Grimmenstein, Austria
Aarhus University Hospital, Neurolog avd.F-NEU-Cent (Site 208001)
🇩🇰Aarhus, Denmark
Hospital Pardubice, Neurology dept. (site 203001)
🇨🇿Pardubice, Czechia
Gaital-Kliniken Hermagor (site 040001)
🇦🇹Hermagor, Austria
AZ St. Jan, Ruddershove 10, (site 056002)
🇧🇪Brugge, Belgium
Faculty Hospital Brno (site 203002)
🇨🇿Brno, Czechia
Hôpital Pellegrin/Rééducation fonctionnelle (site 250012)
🇫🇷Bordeaux, France
Centre Médecine Physique Réadaptation/Rééducation Neurologique (site 250013)
🇫🇷Coubert, France
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 Raymond Poincaré/Rééducation neurologique (site 250002)
🇫🇷Garches, France
Hopital Albert Chenevier/Neurologie, (site 250010)
🇫🇷Créteil, France
CHU Lapeyronie /Rééducation fonctionnelle (site 250014)
🇫🇷Montpellier, France
Centre Médico-Chirurgical de Réadaptation des Massues (Site 250005)
🇫🇷Lyon, France
CHU de Nantes/Médecine physique et de réadaptation neurologique (site 250017)
🇫🇷Nantes, France
Ospedale S. Bartolomeo (site 380005)
🇮🇹Sarzana, Italy
Sächs. KH Neurologie, Hufelandstr. 15 (site 276006)
🇩🇪Arnsdorf, Germany
Catholic University Daejeon St. Mary's Hospital, Daeheung-dong, Jung-gu, (site 410004)
🇰🇷Daejeon, Korea, Republic of
Hôpital Rangueil/Médecine Physique réadaptation (site 250015)
🇫🇷Toulouse, France
NRZ Neurologisches Rehazentrum (site 276004) Muldentalweg 1
🇩🇪Bennewitz, Germany
Clinica di Neuroriabilitatione - Az. Osp. Univ. Ospedali Riuniti (site 380004)
🇮🇹Ancona, Italy
Kliniken der Medizinischen Hochschule (Neurologische Klinik), Carl-Neuberg-Str. 1 (site 276005)
🇩🇪Hannover, Germany
Colonia Ladrón de Guevara (Site 484001)
🇲🇽Guadalajara, Jalisco, Mexico
Inha University Hospital, #7-206 Shinheungdong-ga,Jjung-gu (site 410006)
🇰🇷Incheon, Korea, Republic of
Samsung Medical Center, #50 Ilwon-dong, Gangnam-gu (site 410002)
🇰🇷Seoul, Korea, Republic of
Kinik für Neurologie Paracelsusring 6a (site 276003)
🇩🇪Beelitz, Germany
Angeles del Pedregal (Site 484002)
🇲🇽México City, Mexico
Municipal health care institution "City clinical hospital #3" (site 643006)
🇷🇺Chelyabinsk, Russian Federation
Municipal health care institution "City hospital #2 "Krasnodar Multidisciplinary medical diagnostic association" (site 643004)
🇷🇺Krasnodar, Russian Federation
Dept. of Rehabilitation Yonsei University Severance Hospital (site 410001)
🇰🇷Seoul, Korea, Republic of
Dept. of Rehabilitation Seoul National University Bundang Hospital (site 410003)
🇰🇷Seoul, Korea, Republic of
Hospital Kuala Lumpur (site 458002)
🇲🇾Kuala Lumpur, Malaysia
Universiti Malaya Medical Center/Department of Neurology / Department of Rehabilitation Medicine (site 458001)
🇲🇾Kuala Lumpur, Malaysia
Perpetual Succour Hospital (site 608002)
🇵🇭Cebu City, Philippines
Metropolitan Medical Center (site 608001)
🇵🇭Manila, Philippines
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)
🇵🇹Lisboa, Portugal
Hospital Geral de Santo Antonio, Centro Hospitalar do Porto (site 620002)
🇵🇹Porto, Portugal
Federal State Institution "Medical Rehabilitation Centre of Roszdrav" (site 643001)
🇷🇺Moscow, Russian Federation
Centro de Medicina de Reabilitação de Alcoitão (site 620001)
🇵🇹Alcabideche, Portugal
State Institution "Interregional clinical diagnostic centre" (site 643002)
🇷🇺Kazan, Russian Federation
State Educational Institution of high professional education "Krasnoyarsk State Medical Academy of Roszdrav" (site 643007)
🇷🇺Krasnoyarsk, Russian Federation
State Novosibirsk Regional Clinical Diagnostic Centre (site 643005)
🇷🇺Novosibirsk, Russian Federation
Hospital Universitario La Fe (Site 724003)
🇪🇸Valencia, Spain
Hospital La Paz / Servicio de Rehabilitación (site 724006)
🇪🇸Madrid, Spain
State Educational Institution of high professional education "St-Peterbusrg state medical university named after I.P. Pavlov of Roszdrav" (site 643003)
🇷🇺St-Peterburg, Russian Federation
Singapore General Hospital, Department of Rehabilitation Medicine (site 702002)
🇸🇬Singapore, Singapore
King Chulalongkorn Memorial Hospital/Department of Rehabilitation Medicine (site 764002)
🇹🇭Bangkok, Thailand
Siriraj Hospital/Department of Rehabilitation Medicine (site 764001)
🇹🇭Bangkok, Thailand
Veteran General Hospital (site 158001)
🇨🇳Taipei, Taiwan
Tan Tock Seng Hospital/TTSH Rehabilitation Centre (site 702001)
🇸🇬Singapore, Singapore
Mälarsjukhuset, Dept. Of Neurology (site 752001)
🇸🇪Eskilstuna, Sweden
Läkarhuset Odenplan, Neuro Unit (site 752003)
🇸🇪Stockholm, Sweden
Hospital Morales Meseguer / Servicio de Rehabilitación (site 724005)
🇪🇸Murcia, Spain
Östersunds Rehab Centrum (site 752004)
🇸🇪Östersund, Sweden
Dewsbury District Hospital (site 826004)
🇬🇧Dewsbury, United Kingdom
Lincoln County Hospital (site 826001)
🇬🇧Lincoln, United Kingdom
China Medical University Hospital, Department of Physical Medicine & Rehabilitation (site 158002)
🇨🇳Taichung, Taiwan
Medway Maritime Hospital (site 826002)
🇬🇧Gillingham, United Kingdom
Regional Rehabilitation Unit, Northwick Park Hospital (site 826006)
🇬🇧Middlesex, United Kingdom
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
Rehabilitation Unit, Tung Wah Hospital, 12 Po Yan Street, Sheung Wan (site 344001)
🇨🇳Hong Kong, China
Rankin Park (site 036006)
🇦🇺Newcastle, Australia
CHU Hôpital SUD/Institut de Rééducation (site 250007)
🇫🇷Echirolles, France
CHRU Lille/Rééducation Neurologique (site 250018)
🇫🇷Lille, France
Hopital Jean Rebeyrol/Médecine Physique et de Réadaptation (site 250006)
🇫🇷Limoges, France
Hôpital Timone Adultes/Rééducation fonctionnelle (site 250020)
🇫🇷Marseille, France
Hôpital Sébastopol/Rééducation Fonctionnelle (site 250004)
🇫🇷Reims Cedex, France
Médecine Physique et de Réadaptation Fondation Hospitalière Sainte Marie (site 250001)
🇫🇷Paris, France
Dept. Of Neurology, Nyköping Hospital (site 752002)
🇸🇪Nyköping, Sweden
Dept. for Rehabilitation Asan Medical Center (site 410005)
🇰🇷Seoul, Korea, Republic of
Praxis für Neurologie, Dalberger Str. 6 (site 276007)
🇩🇪Frankfurt, Germany
Paracelsus Klinik Werdauer Str. 68 (site 276002)
🇩🇪Zwickau, Germany
Praxis für Neurologie Mittelstr. 4 (site 276008)
🇩🇪Mannheim, Germany
Hospital Marqués de Valdecilla/ Servicio de Rehabilitación (site 724009)
🇪🇸Santander, Spain
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
Hôpital Pontchaillou/Rééducation Fonctionnelle (site 250003)
🇫🇷Rennes, France
Hôpital Hautepierre/Rééducation fonctionnellev (site 250011)
🇫🇷Strasbourg, France
Azienda Ospedaliera Universitaria (site 380012)
🇮🇹Ferrara, Italy
West Midlands/Rehabilitation Centre (826005)
🇬🇧Plymouth, United Kingdom