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

Upper Limb Spasticity Clinical Trial

— ULIS III  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02454803
• Other study ID #: Y-79-52120-206
• Status: Completed
• Start date: January 2015
• Est. completion date: June 3, 2019

Study information

• Verified date: August 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1004
• Est. completion date: June 3, 2019
• Est. primary completion date: June 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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• Patient has already been included in the current study, but was subsequently withdrawn.

Related Conditions & MeSH terms

• Muscle Spasticity
• Upper Limb Spasticity

Locations

Country	Name	City	State
Australia	Epworth Rehabilitation Camberwell	Camberwell
Australia	St Vincent's Hospital	Darlinghurst
Australia	Austin Health Hospital	Heidelberg
Australia	Liverpool Brain Injury Rehabilitation Unit	Liverpool
Australia	Royal Melbourne Hospital	Parkville
Australia	Prince of Wales Hospital	Randwick
Australia	RPAH	Sidney
Australia	Westmead Hospital	Westmead
Australia	Princess Alexandra Hospital	Woolloongabba
Austria	Gaitlal-Klinik Hermagor	Hermagor
Brazil	Hospital de Clinicas da UFPR	Curitiba
Brazil	Fundacao Faculdade Regional de Medicina	São José do Rio Preto
Brazil	Hospital dos Clinicas Universitaria de Sao Paulo	Sao Paulo
France	Centre Régional de Rééducation et Réadaptation Fonctionnelle	Angers
France	CHU Pellegrin	Bordeaux
France	Hôpital Raymond Poincaré	Garches
France	CHU Grenoble Hôpital Sud	Grenoble
France	Institut Universitaire de Réadaptation de Clémenceau	Strasbourg
Germany	Universitaets-Klinikum Erlangen	Erlangen
Germany	Universitaetsklinikum Leipzig	Leipzig
Germany	Klinikum rechts der Isar der Technischen Universitaet Muenchen	Munich
Germany	Schoen Klinik Muenchen Schwabing	Munich
Germany	Universitaetsklinikum Wuerzburg	Wuerzburg
Hong Kong	Tung Wah Hospital	Hong Kong
Italy	Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona	Ancona
Italy	Azienda Ospedaliero Universitaria Consorziale Policlinico	Bari
Italy	Ospedale Valduce - Villa Beretta	Costa Masnaga
Italy	Azienda Ospedaliero Universitaria di Ferrara	Ferrara
Italy	Azienda Ospedaliero Universitaria Policlinico "G Martino"	Messina
Italy	Fondazione Santa Lucia, I.R.C.C.S.	Roma
Italy	Fondazione Don Carlo Gnocchi Onlus	Sarzana
Mexico	Hospital Angeles Clinica Londres	Ciudad de México
Mexico	Grupo Torre Medica	Mexico
Mexico	National Institute of Neurology/Rehabilitation	Mexico
Mexico	Rehabilitation Centre	Queretaro
Philippines	Perpetual Succour Hospital	Cebu City
Philippines	Metropolitan Medical Center	Manila
Poland	Academy of Neurology	Krakow
Poland	Bonacha	Warsaw
Poland	Public Hospital Wojewodzki	Warsaw
Portugal	Alcoitao Rehabilitation Centre	Alcoitao
Portugal	Hospital de Faro	Faro
Portugal	Hospital Egas Moniz	Lisboa
Russian Federation	Regional State Budgetary Healthcare Institution "City Hospital N°5"	Barnaul
Russian Federation	Interregional Cinical and Diagnostic Centre	Kazan
Russian Federation	Kemerovo Regional Clinical Hospital	Kemerovo
Russian Federation	Krasnoyarsks State Medical University	Krasnoyarsk
Russian Federation	Federal State Hospital for Treatment and Rehabilitation	Moscow
Russian Federation	Pavlov First Saint-Petersburg State Medical University	Saint Petersburg
Russian Federation	Federal State Budgetary Institution	Saint-Petersburg
Taiwan	China Medical University Hospital	Taichung
Taiwan	Veteran General Hospital	Taipei
United States	Rehabilitation Institute of Chicago	Chicago	Illinois
United States	Design Neuroscience	Doral	Florida
United States	Vanderbilt University	Nashville	Tennessee
United States	Kansas City Bone & Joint Clinic	Overland Park	Kansas
United States	Wake Forest School of Medicine	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Brazil,  France,  Germany,  Hong Kong,  Italy,  Mexico,  Philippines,  Poland,  Portugal,  Russian Federation,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient centred goal attainment will be assessed using the cumulated Goal Attainment Scale Total Score (GAS T score).	Goal attainment will be recorded on a five point numerical scale (range -2 to +2) and goal scores combined to give an aggregated T score.	From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)
Secondary	To document the baseline patient characteristics and disease history.	Muscle tone will be evaluated using the Modified Ashworth Scale (MAS). Severity of different aspects of impairment in patients with neurological damage will be evaluated using the Upper Limb Spasticity Neurological Impairment Scale (ULS-NIS) recorded for both upper limbs.	Baseline
Secondary	To document the clinical management of the upper limb spasticity.	BoNT-A injection practices, concomitant drug and non-drug therapies.	From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)
Secondary	Patient centred goal attainment by goal area.	Assessed using the cumulated GAS T score of all goals assessed within each goal area.	From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)
Secondary	Evolution of goal changes across the study will be recorded alongside changes from baseline in the standardised outcome measures.		From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)
Secondary	Assessment of the correlations between patient centred goals and related standardised rating scales.	Using Goal Attainment Scaling Evaluation of Intensity (GASeous) and standardised outcome measures.	From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)
Secondary	Evaluation of change from baseline in the four domains of Disability Assessment Scale (DAS) as well as in the Principal Target of Treatment (PTT).	The DAS will be used at each visit to determine the extent of functional impairment in four domains: hygiene, dressing, limb position and pain. Impairment is assessed on a four point scale (range 0 to 3, where 0=no disability, and 3=severe disability). The PTT will be defined at each visit, based on one of the four DAS domains.	From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)
Secondary	Evolution of quality of life	Assessed at each visit in a subpopulation of English-native speaker patients in Anglophone countries based on two different quality of life instruments, EuroQol 5 Dimensions, 5 levels (EQ 5D 5L) and Spasticity Related Quality of Life Tool (SQoL 6D).	From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)
Secondary	Health economic	Health economic analysis will include changes in concomitant treatments, changes in patient employment status, maintenance of health care (by nurse, caregiver etc) and utility data derived from EQ-5D 5L, DAS, GAS and SQoL-6D.	From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)