Clinical trial NCT01020500: To Document the Effectiveness of BoNT-A Injection in Adult Subjects With Upper Limb Spasticity Following Stroke
Official title: An International, Prospective Cohort to Document the Effectiveness of One BoNT-A Injection Cycle Based on Attainment of Individual Person-centred Goals in Adult Subjects Suffering From Upper Limb Spasticity Following Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Muscle Spasticity
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2009-11-25
Enrollment: 469
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital Clinics

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Contraindications to any BoNT-A preparations

Primary outcomes:
measure: 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
timeFrame: Around 3 to 5 months post injection
Secondary outcomes:
measure: Overall attainment of the treatment goals using the GAS T score
timeFrame: Around 3 to 5 months post injection
measure: Result of standardized outcome measures (e.g., muscle tone reduction, pain scores, arm function test)
timeFrame: Around 3 to 5 months post injection
measure: Global assessment of benefits by both the investigator and the subject (or guardian)
timeFrame: Around 3 to 5 months post injection
Other outcomes:
Locations:
city: Newcastle
country: Australia
facility: Rankin Park (site 036006)
city: Sydney
country: Australia
facility: Northshore Private Hospital (site 036003)
city: Sydney
country: Australia
facility: Royal Prince Alfred Hospital (site 036005)
city: Sydney
country: Australia
facility: Ryde Rehabilitation Center (site 036002)
city: Sydney
country: Australia
facility: St Joseph's Hospital (site 036004)
city: Sydney
country: Australia
facility: St Vincent's Hospital (site 036001)
city: Grimmenstein
country: Austria
facility: NÖ LKH Grimmenstein-Hochegg (site 040002)
city: Hermagor
country: Austria
facility: Gaital-Kliniken Hermagor (site 040001)
city: Antwerpen
country: Belgium
facility: Revalidatieziekenhuis Hof ter Schelde, August Vermeylenlaan 6 (site 056001)
city: Brugge
country: Belgium
facility: AZ St. Jan, Ruddershove 10, (site 056002)
city: Bruxelles
country: Belgium
facility: UCL St. Luc Département de médecine, physique et de readaptation motrice, Avenue Hippocrate 10 (site 056004)
city: Yvoir
country: Belgium
facility: Cliniques Universitaires UCL de Mont-Godinne, Avenue Dr. G. Therasse (site 056003)
city: Hong Kong
country: China
facility: Rehabilitation Unit, Tung Wah Hospital, 12 Po Yan Street, Sheung Wan (site 344001)
city: Brno
country: Czechia
facility: Faculty Hospital Brno (site 203002)
city: Pardubice
country: Czechia
facility: Hospital Pardubice, Neurology dept. (site 203001)
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Neurolog avd.F-NEU-Cent (Site 208001)
city: Copenhagen
country: Denmark
facility: Herlev Hospital, Herlev Ringvej (Site 208004)
city: Glostrup
country: Denmark
facility: Neurologisk afdeling N, Amtssygehuset i Glostrup (Site 208003)
city: Jyväskylä
country: Finland
facility: Department of Physical and Rehabilitation Medicine/Central Hospital of Central Finland (Site 246005)
city: Rovaniemi
country: Finland
facility: Invalidförbundets Rehabiliteringscenter i Lappland (Site 246004)
city: Tampere
country: Finland
facility: Neurologiska Polikliniken, Tampere University Hospital (site 246001)
city: Angers
country: France
facility: Centre Régional de Rééducation et Réadaptation fonctionnelle (site 250008)
city: Argonay
country: France
facility: Centre de Rééducation Fonctionnelle du Mont Veyrier Rééducation fonctionnelle (site 250021)
city: Besançon
country: France
facility: Hôpital Jean Minjoz/Méd.physique réadaptation (site 250016)
city: Bordeaux
country: France
facility: Hôpital Pellegrin/Rééducation fonctionnelle (site 250012)
city: Coubert
country: France
facility: Centre Médecine Physique Réadaptation/Rééducation Neurologique (site 250013)
city: Créteil
country: France
facility: Hopital Albert Chenevier/Neurologie, (site 250010)
city: Echirolles
country: France
facility: CHU Hôpital SUD/Institut de Rééducation (site 250007)
city: Garches
country: France
facility: Hôpital Raymond Poincaré/Rééducation neurologique (site 250002)
city: Lille
country: France
facility: CHRU Lille/Rééducation Neurologique (site 250018)
city: Limoges
country: France
facility: Hopital Jean Rebeyrol/Médecine Physique et de Réadaptation (site 250006)
city: Lyon
country: France
facility: Centre Médico-Chirurgical de Réadaptation des Massues (Site 250005)
city: Marseille
country: France
facility: Hôpital Timone Adultes/Rééducation fonctionnelle (site 250020)
city: Montpellier
country: France
facility: CHU Lapeyronie /Rééducation fonctionnelle (site 250014)
city: Nantes
country: France
facility: CHU de Nantes/Médecine physique et de réadaptation neurologique (site 250017)
city: Paris
country: France
facility: Médecine Physique et de Réadaptation Fondation Hospitalière Sainte Marie (site 250001)
city: Reims Cedex
country: France
facility: Hôpital Sébastopol/Rééducation Fonctionnelle (site 250004)
city: Rennes
country: France
facility: Hôpital Pontchaillou/Rééducation Fonctionnelle (site 250003)
city: Strasbourg
country: France
facility: Hôpital Hautepierre/Rééducation fonctionnellev (site 250011)
city: Toulouse
country: France
facility: Hôpital Rangueil/Médecine Physique réadaptation (site 250015)
city: Arnsdorf
country: Germany
facility: Sächs. KH Neurologie, Hufelandstr. 15 (site 276006)
city: Beelitz
country: Germany
facility: Kinik für Neurologie Paracelsusring 6a (site 276003)
city: Bennewitz
country: Germany
facility: NRZ Neurologisches Rehazentrum (site 276004) Muldentalweg 1
city: Frankfurt
country: Germany
facility: Praxis für Neurologie, Dalberger Str. 6 (site 276007)
city: Hannover
country: Germany
facility: Kliniken der Medizinischen Hochschule (Neurologische Klinik), Carl-Neuberg-Str. 1 (site 276005)
city: Mannheim
country: Germany
facility: Praxis für Neurologie Mittelstr. 4 (site 276008)
city: Zwickau
country: Germany
facility: Paracelsus Klinik Werdauer Str. 68 (site 276002)
city: Ancona
country: Italy
facility: Clinica di Neuroriabilitatione - Az. Osp. Univ. Ospedali Riuniti (site 380004)
city: Ferrara
country: Italy
facility: Azienda Ospedaliera Universitaria (site 380012)
city: Lecco
country: Italy
facility: Ospedale Valduce, Costa Masnaga (site 380001)
city: Pietra Ligure
country: Italy
facility: Laboratorio analisi del Movimento U.O.R.R.F. -Ospedale Santa Corona (site 380002)
city: Pisa
country: Italy
facility: Ospedale Cisanello (site 380010)
city: Sarzana
country: Italy
facility: Ospedale S. Bartolomeo (site 380005)
city: Daejeon
country: Korea, Republic of
facility: Catholic University Daejeon St. Mary's Hospital, Daeheung-dong, Jung-gu, (site 410004)
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital, #7-206 Shinheungdong-ga,Jjung-gu (site 410006)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center, #50 Ilwon-dong, Gangnam-gu (site 410002)
city: Seoul
country: Korea, Republic of
facility: Dept. for Rehabilitation Asan Medical Center (site 410005)
city: Seoul
country: Korea, Republic of
facility: Dept. of Rehabilitation Seoul National University Bundang Hospital (site 410003)
city: Seoul
country: Korea, Republic of
facility: Dept. of Rehabilitation Yonsei University Severance Hospital (site 410001)
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur (site 458002)
city: Kuala Lumpur
country: Malaysia
facility: Universiti Malaya Medical Center/Department of Neurology / Department of Rehabilitation Medicine (site 458001)
city: Guadalajara
country: Mexico
facility: Colonia Ladrón de Guevara (Site 484001)
state: Jalisco
city: México City
country: Mexico
facility: Angeles del Pedregal (Site 484002)
city: Cebu City
country: Philippines
facility: Perpetual Succour Hospital (site 608002)
city: Manila
country: Philippines
facility: Metropolitan Medical Center (site 608001)
city: Alcabideche
country: Portugal
facility: Centro de Medicina de Reabilitação de Alcoitão (site 620001)
city: Coimbra
country: Portugal
facility: Centro Hospitalar de Coimbra - Quinta dos Vales (site 620005)
city: Faro
country: Portugal
facility: Hospital Distrital de Faro (site 620004)
city: Lisboa
country: Portugal
facility: Hospital Egas Moniz, Centro Hospitalar Lisboa Ocidental (site 620003)
city: Porto
country: Portugal
facility: Hospital Geral de Santo Antonio, Centro Hospitalar do Porto (site 620002)
city: Chelyabinsk
country: Russian Federation
facility: Municipal health care institution "City clinical hospital #3" (site 643006)
city: Kazan
country: Russian Federation
facility: State Institution "Interregional clinical diagnostic centre" (site 643002)
city: Krasnodar
country: Russian Federation
facility: Municipal health care institution "City hospital #2 "Krasnodar Multidisciplinary medical diagnostic association" (site 643004)
city: Krasnoyarsk
country: Russian Federation
facility: State Educational Institution of high professional education "Krasnoyarsk State Medical Academy of Roszdrav" (site 643007)
city: Moscow
country: Russian Federation
facility: Federal State Institution "Medical Rehabilitation Centre of Roszdrav" (site 643001)
city: Novosibirsk
country: Russian Federation
facility: State Novosibirsk Regional Clinical Diagnostic Centre (site 643005)
city: St-Peterburg
country: Russian Federation
facility: State Educational Institution of high professional education "St-Peterbusrg state medical university named after I.P. Pavlov of Roszdrav" (site 643003)
city: Singapore
country: Singapore
facility: Singapore General Hospital, Department of Rehabilitation Medicine (site 702002)
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital/TTSH Rehabilitation Centre (site 702001)
city: Madrid
country: Spain
facility: Hospital La Paz / Servicio de Rehabilitación (site 724006)
city: Murcia
country: Spain
facility: Hospital Morales Meseguer / Servicio de Rehabilitación (site 724005)
city: Santander
country: Spain
facility: Hospital Marqués de Valdecilla/ Servicio de Rehabilitación (site 724009)
city: Valencia
country: Spain
facility: Hospital Universitario La Fe (Site 724003)
city: Eskilstuna
country: Sweden
facility: Mälarsjukhuset, Dept. Of Neurology (site 752001)
city: Nyköping
country: Sweden
facility: Dept. Of Neurology, Nyköping Hospital (site 752002)
city: Stockholm
country: Sweden
facility: Läkarhuset Odenplan, Neuro Unit (site 752003)
city: Östersund
country: Sweden
facility: Östersunds Rehab Centrum (site 752004)
city: Taichung
country: Taiwan
facility: China Medical University Hospital, Department of Physical Medicine & Rehabilitation (site 158002)
city: Taipei
country: Taiwan
facility: Veteran General Hospital (site 158001)
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital/Department of Rehabilitation Medicine (site 764002)
city: Bangkok
country: Thailand
facility: Siriraj Hospital/Department of Rehabilitation Medicine (site 764001)
city: Dewsbury
country: United Kingdom
facility: Dewsbury District Hospital (site 826004)
city: Gillingham
country: United Kingdom
facility: Medway Maritime Hospital (site 826002)
city: Lincoln
country: United Kingdom
facility: Lincoln County Hospital (site 826001)
city: Middlesex
country: United Kingdom
facility: Regional Rehabilitation Unit, Northwick Park Hospital (site 826006)
city: Plymouth
country: United Kingdom
facility: West Midlands/Rehabilitation Centre (826005)
Study officials:
affiliation: Ipsen
name: Ipsen Study Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.