Upper Limb SpasticityULIS IIINCT02454803
Attainment of Person-centred Goals After Botulinum Toxin Treatment for Upper Limb Spasticity in Real Life Practice
An observational study of Upper Limb Spasticity, run by Ipsen at 57 sites in 14 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Limb Spasticity
- How many people
- 1,004 participants
- Where
- 57 sitesin 14 countries
- Study dates
- Jan 2015to 3 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient suffering from upper limb spasticity (ULS) seen in clinic, hospital and/or rehabilitation centers.
Who may be able to join
- 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.
Who cannot join
- 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- Patient has already been included in the current study, but was subsequently withdrawn.
Trial locations and contacts
57 sites in 14 countries.
57 sites in 14 countries
Australia9 sites
Epworth Rehabilitation Camberwell
Camberwell, 03124
St Vincent's Hospital
Darlinghurst
Austin Health Hospital
Heidelberg, VIC 3084
Liverpool Brain Injury Rehabilitation Unit
Liverpool, NSW2170
Royal Melbourne Hospital
Parkville, 3052
Prince of Wales Hospital
Randwick, 02232
RPAH
Sydney, 02050
Westmead Hospital
Westmead, NWS 2145
Princess Alexandra Hospital
Woolloongabba, QLD 4102
Italy7 sites
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
Ancona
Azienda Ospedaliero Universitaria Consorziale Policlinico
Bari
Ospedale Valduce - Villa Beretta
Costa Masnaga
Azienda Ospedaliero Universitaria di Ferrara
Ferrara
Azienda Ospedaliero Universitaria Policlinico "G Martino"
Messina
Fondazione Santa Lucia, I.R.C.C.S.
Roma
Fondazione Don Carlo Gnocchi Onlus
Sarzana
Russia7 sites
Regional State Budgetary Healthcare Institution "City Hospital N°5"
Barnaul
Interregional Cinical and Diagnostic Centre
Kazan'
Kemerovo Regional Clinical Hospital
Kemerovo
Krasnoyarsks State Medical University
Krasnoyarsk
Federal State Hospital for Treatment and Rehabilitation
Moscow
Federal State Budgetary Institution
Saint Petersburg
Pavlov First Saint-Petersburg State Medical University
Saint Petersburg
United States5 sites
Rehabilitation Institute of Chicago
Chicago, Illinois, 60611
Design Neuroscience
Doral, Florida, 33172
Vanderbilt University
Nashville, Tennessee, 37235
Kansas City Bone & Joint Clinic
Overland Park, Kansas, 66211
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157
France5 sites
Centre Régional de Rééducation et Réadaptation Fonctionnelle
Angers
CHU Pellegrin
Bordeaux
Hôpital Raymond Poincaré
Garches
CHU Grenoble Hôpital Sud
Grenoble
Institut Universitaire de Réadaptation de Clémenceau
Strasbourg
Germany5 sites
Universitaets-Klinikum Erlangen
Erlangen
Universitaetsklinikum Leipzig
Leipzig
Klinikum rechts der Isar der Technischen Universitaet Muenchen
Munich
Schoen Klinik Muenchen Schwabing
Munich
Universitaetsklinikum Wuerzburg
Würzburg
Mexico4 sites
Grupo Torre Medica
México
National Institute of Neurology/Rehabilitation
México
Hospital Angeles Clinica Londres
Mexico City, 06700
Rehabilitation Centre
Querétaro
Brazil3 sites
Hospital de Clinicas da UFPR
Curitiba
Fundacao Faculdade Regional de Medicina
São José do Rio Preto, 15091-240
Hospital dos Clinicas Universitaria de Sao Paulo
São Paulo, 05403-000
Poland3 sites
Academy of Neurology
Krakow
Bonacha
Warsaw
Public Hospital Wojewodzki
Warsaw
Portugal3 sites
Alcoitao Rehabilitation Centre
Alcoitão
Hospital de Faro
Faro
Hospital Egas Moniz
Lisbon
Philippines2 sites
Perpetual Succour Hospital
Cebu City
Metropolitan Medical Center
Manila
Taiwan2 sites
China Medical University Hospital
Taichung
Veteran General Hospital
Taipei
About this study
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
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.
- Conditions
- Upper Limb Spasticity
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)
Secondary outcomes (8)
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.
Measured: Baseline
To document the clinical management of the upper limb spasticity.
BoNT-A injection practices, concomitant drug and non-drug therapies.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startJan 2015
- Primary completion3 Jun 2019
- Study completion3 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Upper Limb SpasticityStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,004 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02454803
- Sponsor's protocol ID
- Y-79-52120-206
- Acronym
- ULIS III
- Status last verified
- Aug 2019
- First submitted
- 22 May 2015
- Last updated
- 5 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 34932284Turner-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.
PubMed 33206198Turner-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.
PubMed 27315835
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02454803
- Acronym / sponsor ID
- ULIS III / Y-79-52120-206
- Conditions
- Upper Limb Spasticity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,004 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- 3 Jun 2019 (actual)
- Study completion
- 3 Jun 2019 (actual)
- First posted
- 27 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient suffering from upper limb spasticity (ULS) seen in clinic, hospital and/or rehabilitation centers.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient centred goal attainment will be assessed using the cumulated Goal Attainment Scale Total Score (GAS T score).
Time frame: From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)
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.
8 secondary outcomes
To document the baseline patient characteristics and disease history.
Time frame: Baseline
To document the clinical management of the upper limb spasticity.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)
Evolution of quality of life
Time frame: From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)
Health economic
Time frame: From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
- Derived from this study: PubMed 34932284Khat'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.
- Derived from this study: PubMed 33206198Turner-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.
- Derived from this study: PubMed 27315835Turner-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
57 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Limb Spasticity, run by Ipsen at 57 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in Australia, Italy, Russia, United States, France and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient centred goal attainment will be assessed using the cumulated Goal Attainment Scale Total Score (GAS T score). (time frame: From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02454803, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2019.