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

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

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.

Study Overview

• Status: Completed
• Conditions: Upper Limb Spasticity

• Study Type: Observational
• Enrollment (Actual): 1004

Contacts and Locations

Study Locations

• Australia
  • Camberwell, Australia, 03124
    • Epworth Rehabilitation Camberwell
  • Darlinghurst, Australia
    • St Vincent's Hospital
  • Heidelberg, Australia, VIC 3084
    • Austin Health Hospital
  • Liverpool, Australia, NSW2170
    • Liverpool Brain Injury Rehabilitation Unit
  • Parkville, Australia, 3052
    • Royal Melbourne Hospital
  • Randwick, Australia, 02232
    • Prince of Wales Hospital
  • Sidney, Australia, 02050
    • RPAH
  • Westmead, Australia, NWS 2145
    • Westmead Hospital
  • Woolloongabba, Australia, QLD 4102
    • Princess Alexandra Hospital
• Austria
  • Hermagor, Austria, 09620
    • Gaitlal-Klinik Hermagor
• Brazil
  • Curitiba, Brazil
    • Hospital de Clinicas da UFPR
  • Sao Paulo, Brazil, 05403-000
    • Hospital dos Clinicas Universitaria de Sao Paulo
  • São José do Rio Preto, Brazil, 15091-240
    • Fundacao Faculdade Regional de Medicina
• France
  • Angers, France
    • Centre Régional de Rééducation et Réadaptation Fonctionnelle
  • Bordeaux, France
    • CHU Pellegrin
  • Garches, France
    • Hôpital Raymond Poincaré
  • Grenoble, France
    • CHU Grenoble Hôpital Sud
  • Strasbourg, France
    • Institut Universitaire de Réadaptation de Clémenceau
• Germany
  • Erlangen, Germany
    • Universitaets-Klinikum Erlangen
  • Leipzig, Germany
    • Universitaetsklinikum Leipzig
  • Munich, Germany
    • Klinikum Rechts der Isar der Technischen Universitaet Muenchen
  • Munich, Germany
    • Schoen Klinik Muenchen Schwabing
  • Wuerzburg, Germany
    • Universitaetsklinikum Wuerzburg
• Hong Kong
  • Hong Kong, Hong Kong
    • Tung Wah Hospital
• Italy
  • Ancona, Italy
    • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
  • Bari, Italy
    • Azienda Ospedaliero Universitaria Consorziale Policlinico
  • Costa Masnaga, Italy
    • Ospedale Valduce - Villa Beretta
  • Ferrara, Italy
    • Azienda Ospedaliero Universitaria di Ferrara
  • Messina, Italy
    • Azienda Ospedaliero Universitaria Policlinico "G Martino"
  • Roma, Italy
    • Fondazione Santa Lucia, I.R.C.C.S.
  • Sarzana, Italy
    • Fondazione Don Carlo Gnocchi Onlus
• Mexico
  • Ciudad de México, Mexico, 06700
    • Hospital Angeles Clinica Londres
  • Mexico, Mexico
    • Grupo Torre Medica
  • Mexico, Mexico
    • National Institute of Neurology/Rehabilitation
  • Queretaro, Mexico
    • Rehabilitation Centre
• Philippines
  • Cebu City, Philippines
    • Perpetual Succour Hospital
  • Manila, Philippines
    • Metropolitan Medical Center
• Poland
  • Krakow, Poland
    • Academy of Neurology
  • Warsaw, Poland
    • Bonacha
  • Warsaw, Poland
    • Public Hospital Wojewodzki
• Portugal
  • Alcoitao, Portugal
    • Alcoitao Rehabilitation Centre
  • Faro, Portugal
    • Hospital de Faro
  • Lisboa, Portugal
    • Hospital Egas Moniz
• Russian Federation
  • Barnaul, Russian Federation
    • Regional State Budgetary Healthcare Institution "City Hospital N°5"
  • Kazan, Russian Federation
    • Interregional Cinical and Diagnostic Centre
  • Kemerovo, Russian Federation
    • Kemerovo Regional Clinical Hospital
  • Krasnoyarsk, Russian Federation
    • Krasnoyarsks State Medical University
  • Moscow, Russian Federation
    • Federal State Hospital for Treatment and Rehabilitation
  • Saint Petersburg, Russian Federation
    • Pavlov First Saint-Petersburg State Medical University
  • Saint-Petersburg, Russian Federation
    • Federal State Budgetary Institution
• Taiwan
  • Taichung, Taiwan
    • China Medical University Hospital
  • Taipei, Taiwan
    • Veteran General Hospital
• United States
  • Florida
    • Doral, Florida, United States, 33172
      • Design Neuroscience
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Rehabilitation Institute of Chicago
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Kansas City Bone & Joint Clinic
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest School of Medicine
  • Tennessee
    • Nashville, Tennessee, United States, 37235
      • Vanderbilt University

Participation Criteria

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

Patient suffering from upper limb spasticity (ULS) seen in clinic, hospital and/or rehabilitation centers.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Ipsen

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): June 3, 2019
• Study Completion (Actual): June 3, 2019

Study Registration Dates

• First Submitted: May 22, 2015
• First Submitted That Met QC Criteria: May 22, 2015
• First Posted (Estimate): May 27, 2015

Study Record Updates

• Last Update Posted (Actual): August 5, 2019
• Last Update Submitted That Met QC Criteria: August 1, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Muscle Spasticity
• Other Study ID Numbers: Y-79-52120-206