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

August 1, 2019 updated by: Ipsen

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1004

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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 Clínicas 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
        • Hopital Raymond Poincare
      • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To document the baseline patient characteristics and disease history.
Time Frame: Baseline
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.
Time Frame: From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)
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.
Time Frame: From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)
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.
Time Frame: From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)
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)
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).
Time Frame: From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)
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
Time Frame: From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)
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
Time Frame: From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ipsen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 3, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 3, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 27, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Y-79-52120-206

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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