Attainment of Person-centred Goals After Botulinum Toxin Treatment for Upper Limb Spasticity in Real Life Practice

NCT ID: NCT02454803

Last Updated: 2019-08-05

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

1004 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2019-06-03

Brief Summary

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The primary purpose for this study is to understand the effect of botulinum toxin as a treatment integrated in the management of spasticity (stiffness) in the arm and/or hand, arising from any neurological condition. The study will look at the types of goals that people choose for treatment, and the extent to which these are achieved in different individuals.

Detailed Description

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Conditions

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Upper Limb Spasticity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Adult patients with ULS, in whom a decision has already been made to inject botulinum toxin A (BoNT A).
* Patient has provided written informed consent for collection of the data.

Exclusion Criteria

* Participation in any interventional clinical study of ULS within the 12 weeks prior to the inclusion visit (Visit 1).
* Patient has already been included in the current study, but was subsequently withdrawn.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ipsen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

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Design Neuroscience

Doral, Florida, United States

Site Status

Rehabilitation Institute of Chicago

Chicago, Illinois, United States

Site Status

Kansas City Bone & Joint Clinic

Overland Park, Kansas, United States

Site Status

Wake Forest School of Medicine

Winston-Salem, North Carolina, United States

Site Status

Vanderbilt University

Nashville, Tennessee, United States

Site Status

Epworth Rehabilitation Camberwell

Camberwell, , Australia

Site Status

St Vincent's Hospital

Darlinghurst, , Australia

Site Status

Austin Health Hospital

Heidelberg, , Australia

Site Status

Liverpool Brain Injury Rehabilitation Unit

Liverpool, , Australia

Site Status

Royal Melbourne Hospital

Parkville, , Australia

Site Status

Prince of Wales Hospital

Randwick, , Australia

Site Status

RPAH

Sydney, , Australia

Site Status

Westmead Hospital

Westmead, , Australia

Site Status

Princess Alexandra Hospital

Woolloongabba, , Australia

Site Status

Gaitlal-Klinik Hermagor

Hermagor, , Austria

Site Status

Hospital de Clinicas da UFPR

Curitiba, , Brazil

Site Status

Fundacao Faculdade Regional de Medicina

São José do Rio Preto, , Brazil

Site Status

Hospital dos Clinicas Universitaria de Sao Paulo

São Paulo, , Brazil

Site Status

Centre Régional de Rééducation et Réadaptation Fonctionnelle

Angers, , France

Site Status

CHU Pellegrin

Bordeaux, , France

Site Status

Hôpital Raymond Poincaré

Garches, , France

Site Status

CHU Grenoble Hôpital Sud

Grenoble, , France

Site Status

Institut Universitaire de Réadaptation de Clémenceau

Strasbourg, , France

Site Status

Universitaets-Klinikum Erlangen

Erlangen, , Germany

Site Status

Universitaetsklinikum Leipzig

Leipzig, , Germany

Site Status

Klinikum rechts der Isar der Technischen Universitaet Muenchen

Munich, , Germany

Site Status

Schoen Klinik Muenchen Schwabing

Munich, , Germany

Site Status

Universitaetsklinikum Wuerzburg

Würzburg, , Germany

Site Status

Tung Wah Hospital

Hong Kong, , Hong Kong

Site Status

Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

Ancona, , Italy

Site Status

Azienda Ospedaliero Universitaria Consorziale Policlinico

Bari, , Italy

Site Status

Ospedale Valduce - Villa Beretta

Costa Masnaga, , Italy

Site Status

Azienda Ospedaliero Universitaria di Ferrara

Ferrara, , Italy

Site Status

Azienda Ospedaliero Universitaria Policlinico "G Martino"

Messina, , Italy

Site Status

Fondazione Santa Lucia, I.R.C.C.S.

Roma, , Italy

Site Status

Fondazione Don Carlo Gnocchi Onlus

Sarzana, , Italy

Site Status

Hospital Angeles Clinica Londres

Mexico City, , Mexico

Site Status

Grupo Torre Medica

México, , Mexico

Site Status

National Institute of Neurology/Rehabilitation

México, , Mexico

Site Status

Rehabilitation Centre

Querétaro, , Mexico

Site Status

Perpetual Succour Hospital

Cebu City, , Philippines

Site Status

Metropolitan Medical Center

Manila, , Philippines

Site Status

Academy of Neurology

Krakow, , Poland

Site Status

Bonacha

Warsaw, , Poland

Site Status

Public Hospital Wojewodzki

Warsaw, , Poland

Site Status

Alcoitao Rehabilitation Centre

Alcoitão, , Portugal

Site Status

Hospital de Faro

Faro, , Portugal

Site Status

Hospital Egas Moniz

Lisbon, , Portugal

Site Status

Regional State Budgetary Healthcare Institution "City Hospital N°5"

Barnaul, , Russia

Site Status

Interregional Cinical and Diagnostic Centre

Kazan', , Russia

Site Status

Kemerovo Regional Clinical Hospital

Kemerovo, , Russia

Site Status

Krasnoyarsks State Medical University

Krasnoyarsk, , Russia

Site Status

Federal State Hospital for Treatment and Rehabilitation

Moscow, , Russia

Site Status

Federal State Budgetary Institution

Saint Petersburg, , Russia

Site Status

Pavlov First Saint-Petersburg State Medical University

Saint Petersburg, , Russia

Site Status

China Medical University Hospital

Taichung, , Taiwan

Site Status

Veteran General Hospital

Taipei, , Taiwan

Site Status

Countries

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United States Australia Austria Brazil France Germany Hong Kong Italy Mexico Philippines Poland Portugal Russia Taiwan

References

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Khat'kova SE, Baikova A, Maisonobe P, Khasanova DR. [Impact of integrated upper limb spasticity management including repeat botulinum toxin type A (BoNT-A) injections on patient-centred goal attainment in real-life practice: results from the prospective, observational Upper Limb International Spasticity cohort study (ULIS-III) in a Russian subpopulation]. Zh Nevrol Psikhiatr Im S S Korsakova. 2021;121(11):39-48. doi: 10.17116/jnevro202112111139. Russian.

Reference Type DERIVED
PMID: 34932284 (View on PubMed)

Turner-Stokes L, Jacinto J, Fheodoroff K, Brashear A, Maisonobe P, Lysandropoulos A, Ashford S; Upper Limb International Spasticity-III (ULIS-III) study group. Assessing the effectiveness of upper-limb spasticity management using a structured approach to goal-setting and outcome measurement: First cycle results from the ULIS-III Study. J Rehabil Med. 2021 Jan 1;53(1):jrm00133. doi: 10.2340/16501977-2770.

Reference Type DERIVED
PMID: 33206198 (View on PubMed)

Turner-Stokes L, Ashford S, Jacinto J, Maisonobe P, Balcaitiene J, Fheodoroff K. Impact of integrated upper limb spasticity management including botulinum toxin A on patient-centred goal attainment: rationale and protocol for an international prospective, longitudinal cohort study (ULIS-III). BMJ Open. 2016 Jun 17;6(6):e011157. doi: 10.1136/bmjopen-2016-011157.

Reference Type DERIVED
PMID: 27315835 (View on PubMed)

Other Identifiers

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Y-79-52120-206

Identifier Type: -

Identifier Source: org_study_id

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