Clinical trial NCT02454803: Attainment of Person-centred Goals After Botulinum Toxin Treatment for Upper Limb Spasticity in Real Life Practice
Official title: An International, Multicentre, Observational, Prospective, Longitudinal Cohort Study to Assess the Impact of Integrated Upper Limb Spasticity Management Including the Use of BoNT-A- Injections on Patient-centred Goal Attainment in Real Life Practice - ULIS III
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Upper Limb Spasticity
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2015-05-27
Enrollment: 1004
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: Patient suffering from upper limb spasticity (ULS) seen in clinic, hospital and/or rehabilitation centers.

Brief summary: 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.


Eligibility criteria: 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* Patient has already been included in the current study, but was subsequently withdrawn.

Primary outcomes:
measure: Patient centred goal attainment will be assessed using the cumulated Goal Attainment Scale Total Score (GAS T score).
timeFrame: From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)
Secondary outcomes:
measure: To document the baseline patient characteristics and disease history.
timeFrame: Baseline
measure: To document the clinical management of the upper limb spasticity.
timeFrame: From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)
measure: Patient centred goal attainment by goal area.
timeFrame: From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)
measure: Evolution of goal changes across the study will be recorded alongside changes from baseline in the standardised outcome measures.
timeFrame: From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)
measure: Assessment of the correlations between patient centred goals and related standardised rating scales.
timeFrame: From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)
measure: Evaluation of change from baseline in the four domains of Disability Assessment Scale (DAS) as well as in the Principal Target of Treatment (PTT).
timeFrame: From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)
measure: Evolution of quality of life
timeFrame: From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)
measure: Health economic
timeFrame: From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)
Other outcomes:
Locations:
city: Doral
country: United States
facility: Design Neuroscience
state: Florida
city: Chicago
country: United States
facility: Rehabilitation Institute of Chicago
state: Illinois
city: Overland Park
country: United States
facility: Kansas City Bone & Joint Clinic
state: Kansas
city: Winston-Salem
country: United States
facility: Wake Forest School of Medicine
state: North Carolina
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Camberwell
country: Australia
facility: Epworth Rehabilitation Camberwell
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital
city: Heidelberg
country: Australia
facility: Austin Health Hospital
city: Liverpool
country: Australia
facility: Liverpool Brain Injury Rehabilitation Unit
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
city: Randwick
country: Australia
facility: Prince of Wales Hospital
city: Sidney
country: Australia
facility: RPAH
city: Westmead
country: Australia
facility: Westmead Hospital
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
city: Hermagor
country: Austria
facility: Gaitlal-Klinik Hermagor
city: Curitiba
country: Brazil
facility: Hospital de Clinicas da UFPR
city: Sao Paulo
country: Brazil
facility: Hospital dos Clinicas Universitaria de Sao Paulo
city: São José do Rio Preto
country: Brazil
facility: Fundacao Faculdade Regional de Medicina
city: Angers
country: France
facility: Centre Régional de Rééducation et Réadaptation Fonctionnelle
city: Bordeaux
country: France
facility: CHU Pellegrin
city: Garches
country: France
facility: Hôpital Raymond Poincaré
city: Grenoble
country: France
facility: CHU Grenoble Hôpital Sud
city: Strasbourg
country: France
facility: Institut Universitaire de Réadaptation de Clémenceau
city: Erlangen
country: Germany
facility: Universitaets-Klinikum Erlangen
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig
city: Munich
country: Germany
facility: Klinikum rechts der Isar der Technischen Universitaet Muenchen
city: Munich
country: Germany
facility: Schoen Klinik Muenchen Schwabing
city: Wuerzburg
country: Germany
facility: Universitaetsklinikum Wuerzburg
city: Hong Kong
country: Hong Kong
facility: Tung Wah Hospital
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
city: Bari
country: Italy
facility: Azienda Ospedaliero Universitaria Consorziale Policlinico
city: Costa Masnaga
country: Italy
facility: Ospedale Valduce - Villa Beretta
city: Ferrara
country: Italy
facility: Azienda Ospedaliero Universitaria di Ferrara
city: Messina
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico "G Martino"
city: Roma
country: Italy
facility: Fondazione Santa Lucia, I.R.C.C.S.
city: Sarzana
country: Italy
facility: Fondazione Don Carlo Gnocchi Onlus
city: Ciudad de México
country: Mexico
facility: Hospital Angeles Clinica Londres
city: Mexico
country: Mexico
facility: Grupo Torre Medica
city: Mexico
country: Mexico
facility: National Institute of Neurology/Rehabilitation
city: Queretaro
country: Mexico
facility: Rehabilitation Centre
city: Cebu City
country: Philippines
facility: Perpetual Succour Hospital
city: Manila
country: Philippines
facility: Metropolitan Medical Center
city: Krakow
country: Poland
facility: Academy of Neurology
city: Warsaw
country: Poland
facility: Bonacha
city: Warsaw
country: Poland
facility: Public Hospital Wojewodzki
city: Alcoitao
country: Portugal
facility: Alcoitao Rehabilitation Centre
city: Faro
country: Portugal
facility: Hospital de Faro
city: Lisboa
country: Portugal
facility: Hospital Egas Moniz
city: Barnaul
country: Russian Federation
facility: Regional State Budgetary Healthcare Institution "City Hospital N°5"
city: Kazan
country: Russian Federation
facility: Interregional Cinical and Diagnostic Centre
city: Kemerovo
country: Russian Federation
facility: Kemerovo Regional Clinical Hospital
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsks State Medical University
city: Moscow
country: Russian Federation
facility: Federal State Hospital for Treatment and Rehabilitation
city: Saint Petersburg
country: Russian Federation
facility: Pavlov First Saint-Petersburg State Medical University
city: Saint-Petersburg
country: Russian Federation
facility: Federal State Budgetary Institution
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei
country: Taiwan
facility: Veteran General Hospital
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.