To Document the Effectiveness of BoNT-A Injection in Adult Subjects With Upper Limb Spasticity Following Stroke (ULIS2)

November 4, 2020 updated by: Ipsen

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

469

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Newcastle, Australia
        • Rankin Park (site 036006)
      • Sydney, 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)
  • Austria
      • Grimmenstein, Austria
        • NÖ LKH Grimmenstein-Hochegg (site 040002)
      • Hermagor, Austria
        • Gaital-Kliniken Hermagor (site 040001)
  • Belgium
      • Antwerpen, Belgium, 2050
        • Revalidatieziekenhuis Hof ter Schelde, August Vermeylenlaan 6 (site 056001)
      • Brugge, Belgium, 8000
        • AZ St. Jan, Ruddershove 10, (site 056002)
      • Bruxelles, Belgium, 1200
        • UCL St. Luc Département de médecine, physique et de readaptation motrice, Avenue Hippocrate 10 (site 056004)
      • Yvoir, Belgium, 5530
        • Cliniques Universitaires UCL de Mont-Godinne, Avenue Dr. G. Therasse (site 056003)
  • China
      • Hong Kong, China
        • Rehabilitation Unit, Tung Wah Hospital, 12 Po Yan Street, Sheung Wan (site 344001)
  • Czechia
      • Brno, Czechia
        • Faculty Hospital Brno (site 203002)
      • Pardubice, Czechia
        • Hospital Pardubice, Neurology dept. (site 203001)
  • Denmark
      • Aarhus, Denmark
        • Aarhus University Hospital, Neurolog avd.F-NEU-Cent (Site 208001)
      • Copenhagen, Denmark
        • Herlev Hospital, Herlev Ringvej (Site 208004)
      • Glostrup, Denmark
        • Neurologisk afdeling N, Amtssygehuset i Glostrup (Site 208003)
  • Finland
      • Jyväskylä, Finland
        • Department of Physical and Rehabilitation Medicine/Central Hospital of Central Finland (Site 246005)
      • Rovaniemi, Finland
        • Invalidförbundets Rehabiliteringscenter i Lappland (Site 246004)
      • Tampere, Finland
        • Neurologiska Polikliniken, Tampere University Hospital (site 246001)
  • France
      • Angers, France, Cedex 02
        • Centre Régional de Rééducation et Réadaptation fonctionnelle (site 250008)
      • Argonay, France
        • Centre de Rééducation Fonctionnelle du Mont Veyrier Rééducation fonctionnelle (site 250021)
      • Besançon, France
        • Hôpital Jean Minjoz/Méd.physique réadaptation (site 250016)
      • Bordeaux, France
        • Hôpital Pellegrin/Rééducation fonctionnelle (site 250012)
      • Coubert, France
        • Centre Médecine Physique Réadaptation/Rééducation Neurologique (site 250013)
      • Créteil, France
        • Hopital Albert Chenevier/Neurologie, (site 250010)
      • Echirolles, France
        • CHU Hôpital SUD/Institut de Rééducation (site 250007)
      • Garches, France
        • Hôpital Raymond Poincaré/Rééducation neurologique (site 250002)
      • Lille, France
        • CHRU Lille/Rééducation Neurologique (site 250018)
      • Limoges, France, CEDEX 1
        • Hopital Jean Rebeyrol/Médecine Physique et de Réadaptation (site 250006)
      • Lyon, France, CEDEX 05
        • Centre Médico-Chirurgical de Réadaptation des Massues (Site 250005)
      • Marseille, France, CEDEX 05
        • Hôpital Timone Adultes/Rééducation fonctionnelle (site 250020)
      • Montpellier, France
        • CHU Lapeyronie /Rééducation fonctionnelle (site 250014)
      • Nantes, France, CEDEX 1
        • CHU de Nantes/Médecine physique et de réadaptation neurologique (site 250017)
      • Paris, France
        • Médecine Physique et de Réadaptation Fondation Hospitalière Sainte Marie (site 250001)
      • Reims Cedex, France
        • Hôpital Sébastopol/Rééducation Fonctionnelle (site 250004)
      • Rennes, France, CEDEX 9
        • Hôpital Pontchaillou/Rééducation Fonctionnelle (site 250003)
      • Strasbourg, France, CEDEX 2
        • Hôpital Hautepierre/Rééducation fonctionnellev (site 250011)
      • Toulouse, France, CEDEX 9
        • Hôpital Rangueil/Médecine Physique réadaptation (site 250015)
  • Germany
      • Arnsdorf, Germany, 01477
        • Sächs. KH Neurologie, Hufelandstr. 15 (site 276006)
      • Beelitz, Germany, 14547
        • Kinik für Neurologie Paracelsusring 6a (site 276003)
      • Bennewitz, Germany, 04828
        • NRZ Neurologisches Rehazentrum (site 276004) Muldentalweg 1
      • Frankfurt, Germany, 65929
        • Praxis für Neurologie, Dalberger Str. 6 (site 276007)
      • Hannover, Germany, 30625
        • Kliniken der Medizinischen Hochschule (Neurologische Klinik), Carl-Neuberg-Str. 1 (site 276005)
      • Mannheim, Germany, 68169
        • Praxis für Neurologie Mittelstr. 4 (site 276008)
      • Zwickau, Germany, 08060
        • Paracelsus Klinik Werdauer Str. 68 (site 276002)
  • Italy
      • Ancona, Italy
        • Clinica di Neuroriabilitatione - Az. Osp. Univ. Ospedali Riuniti (site 380004)
      • Ferrara, Italy
        • Azienda Ospedaliera Universitaria (site 380012)
      • Lecco, Italy
        • Ospedale Valduce, Costa Masnaga (site 380001)
      • Pietra Ligure, Italy
        • Laboratorio analisi del Movimento U.O.R.R.F. -Ospedale Santa Corona (site 380002)
      • Pisa, Italy
        • Ospedale Cisanello (site 380010)
      • Sarzana, Italy
        • Ospedale S. Bartolomeo (site 380005)
  • Korea, Republic of
      • Daejeon, Korea, Republic of, 520-2
        • Catholic University Daejeon St. Mary's Hospital, Daeheung-dong, Jung-gu, (site 410004)
      • Incheon, Korea, Republic of, 400-711
        • Inha University Hospital, #7-206 Shinheungdong-ga,Jjung-gu (site 410006)
      • Seoul, Korea, Republic of, 135-710
        • Samsung Medical Center, #50 Ilwon-dong, Gangnam-gu (site 410002)
      • Seoul, Korea, Republic of
        • Dept. for Rehabilitation Asan Medical Center (site 410005)
      • Seoul, Korea, Republic of
        • Dept. of Rehabilitation Seoul National University Bundang Hospital (site 410003)
      • Seoul, Korea, Republic of
        • Dept. of Rehabilitation Yonsei University Severance Hospital (site 410001)
  • Malaysia
      • Kuala Lumpur, Malaysia
        • Hospital Kuala Lumpur (site 458002)
      • Kuala Lumpur, Malaysia
        • Universiti Malaya Medical Center/Department of Neurology / Department of Rehabilitation Medicine (site 458001)
  • Mexico
      • México City, Mexico
        • Angeles del Pedregal (Site 484002)
    • Jalisco
      • Guadalajara, Jalisco, Mexico
        • Colonia Ladrón de Guevara (Site 484001)
  • Philippines
      • Cebu City, Philippines
        • Perpetual Succour Hospital (site 608002)
      • Manila, Philippines
        • Metropolitan Medical Center (site 608001)
  • Portugal
      • Alcabideche, Portugal
        • Centro de Medicina de Reabilitação de Alcoitão (site 620001)
      • Coimbra, Portugal
        • Centro Hospitalar de Coimbra - Quinta dos Vales (site 620005)
      • Faro, Portugal
        • Hospital Distrital de Faro (site 620004)
      • Lisboa, Portugal
        • Hospital Egas Moniz, Centro Hospitalar Lisboa Ocidental (site 620003)
      • Porto, Portugal
        • Hospital Geral de Santo Antonio, Centro Hospitalar do Porto (site 620002)
  • Russian Federation
      • Chelyabinsk, Russian Federation
        • Municipal health care institution "City clinical hospital #3" (site 643006)
      • Kazan, Russian Federation
        • State Institution "Interregional clinical diagnostic centre" (site 643002)
      • Krasnodar, Russian Federation
        • Municipal health care institution "City hospital #2 "Krasnodar Multidisciplinary medical diagnostic association" (site 643004)
      • Krasnoyarsk, Russian Federation
        • State Educational Institution of high professional education "Krasnoyarsk State Medical Academy of Roszdrav" (site 643007)
      • Moscow, Russian Federation
        • Federal State Institution "Medical Rehabilitation Centre of Roszdrav" (site 643001)
      • Novosibirsk, Russian Federation
        • State Novosibirsk Regional Clinical Diagnostic Centre (site 643005)
      • St-Peterburg, Russian Federation
        • State Educational Institution of high professional education "St-Peterbusrg state medical university named after I.P. Pavlov of Roszdrav" (site 643003)
  • Singapore
      • Singapore, Singapore
        • Singapore General Hospital, Department of Rehabilitation Medicine (site 702002)
      • Singapore, Singapore
        • Tan Tock Seng Hospital/TTSH Rehabilitation Centre (site 702001)
  • Spain
      • Madrid, Spain
        • Hospital La Paz / Servicio de Rehabilitación (site 724006)
      • Murcia, Spain
        • Hospital Morales Meseguer / Servicio de Rehabilitación (site 724005)
      • Santander, Spain
        • Hospital Marqués de Valdecilla/ Servicio de Rehabilitación (site 724009)
      • Valencia, Spain
        • Hospital Universitario La Fe (Site 724003)
  • Sweden
      • Eskilstuna, Sweden
        • Mälarsjukhuset, Dept. Of Neurology (site 752001)
      • Nyköping, Sweden
        • Dept. Of Neurology, Nyköping Hospital (site 752002)
      • Stockholm, Sweden
        • Läkarhuset Odenplan, Neuro Unit (site 752003)
      • Östersund, Sweden
        • Östersunds Rehab Centrum (site 752004)
  • Taiwan
      • Taichung, Taiwan
        • China Medical University Hospital, Department of Physical Medicine & Rehabilitation (site 158002)
      • Taipei, Taiwan
        • Veteran General Hospital (site 158001)
  • Thailand
      • Bangkok, Thailand
        • King Chulalongkorn Memorial Hospital/Department of Rehabilitation Medicine (site 764002)
      • Bangkok, Thailand
        • Siriraj Hospital/Department of Rehabilitation Medicine (site 764001)
  • United Kingdom
      • Dewsbury, United Kingdom, WF13 4HS
        • Dewsbury District Hospital (site 826004)
      • Gillingham, United Kingdom, ME7 5NY
        • Medway Maritime Hospital (site 826002)
      • Lincoln, United Kingdom, LN2 5QY
        • Lincoln County Hospital (site 826001)
      • Middlesex, United Kingdom, HA1 3UJ
        • Regional Rehabilitation Unit, Northwick Park Hospital (site 826006)
      • Plymouth, United Kingdom
        • West Midlands/Rehabilitation Centre (826005)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospital Clinics

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: Around 3 to 5 months post injection
Around 3 to 5 months post injection

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall attainment of the treatment goals using the GAS T score
Time Frame: Around 3 to 5 months post injection
Around 3 to 5 months post injection
Result of standardized outcome measures (e.g., muscle tone reduction, pain scores, arm function test)
Time Frame: Around 3 to 5 months post injection
Around 3 to 5 months post injection
Global assessment of benefits by both the investigator and the subject (or guardian)
Time Frame: Around 3 to 5 months post injection
Around 3 to 5 months post injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

November 24, 2009

First Submitted That Met QC Criteria

November 24, 2009

First Posted (Estimate)

November 25, 2009

Study Record Updates

Last Update Posted (Actual)

November 6, 2020

Last Update Submitted That Met QC Criteria

November 4, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Y-79-52120-138

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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