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

NCT02454803 | Completed

• 1 other identifier: Y-79-52120-206
• Study Type: observational
• Target: 1,004
• Locations: 13 countries
• Sites: 48

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.

Conditions

Upper Limb Spasticity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• To document the baseline patient characteristics and disease history.

  Baseline

• To document the clinical management of the upper limb spasticity.

  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.

  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.

  From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Patient has already been included in the current study, but was subsequently withdrawn.

Sponsors & Collaborators

• Ipsen: lead

Study Sites (57)

Design Neuroscience

Doral, Florida, 33172, United States

Location

Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

Location

Kansas City Bone & Joint Clinic

Overland Park, Kansas, 66211, United States

Location

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

Vanderbilt University

Nashville, Tennessee, 37235, United States

Location

Epworth Rehabilitation Camberwell

Camberwell, 03124, Australia

Location

St Vincent's Hospital

Darlinghurst, Australia

Location

Austin Health Hospital

Heidelberg, VIC 3084, Australia

Location

Liverpool Brain Injury Rehabilitation Unit

Liverpool, NSW2170, Australia

Location

Royal Melbourne Hospital

Parkville, 3052, Australia

Location

Prince of Wales Hospital

Randwick, 02232, Australia

Location

RPAH

Sydney, 02050, Australia

Location

Westmead Hospital

Westmead, NWS 2145, Australia

Location

Princess Alexandra Hospital

Woolloongabba, QLD 4102, Australia

Location

Gaitlal-Klinik Hermagor

Hermagor, 09620, Austria

Location

Hospital de Clinicas da UFPR

Curitiba, Brazil

Location

Fundacao Faculdade Regional de Medicina

São José do Rio Preto, 15091-240, Brazil

Location

Hospital dos Clinicas Universitaria de Sao Paulo

São Paulo, 05403-000, Brazil

Location

Centre Régional de Rééducation et Réadaptation Fonctionnelle

Angers, France

Location

CHU Pellegrin

Bordeaux, France

Location

Hôpital Raymond Poincaré

Garches, France

Location

CHU Grenoble Hôpital Sud

Grenoble, France

Location

Institut Universitaire de Réadaptation de Clémenceau

Strasbourg, France

Location

Universitaets-Klinikum Erlangen

Erlangen, Germany

Location

Universitaetsklinikum Leipzig

Leipzig, Germany

Location

Klinikum rechts der Isar der Technischen Universitaet Muenchen

Munich, Germany

Location

Schoen Klinik Muenchen Schwabing

Munich, Germany

Location

Universitaetsklinikum Wuerzburg

Würzburg, Germany

Location

Tung Wah Hospital

Hong Kong, Hong Kong

Location

Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

Ancona, Italy

Location

Azienda Ospedaliero Universitaria Consorziale Policlinico

Bari, Italy

Location

Ospedale Valduce - Villa Beretta

Costa Masnaga, Italy

Location

Azienda Ospedaliero Universitaria di Ferrara

Ferrara, Italy

Location

Azienda Ospedaliero Universitaria Policlinico "G Martino"

Messina, Italy

Location

Fondazione Santa Lucia, I.R.C.C.S.

Roma, Italy

Location

Fondazione Don Carlo Gnocchi Onlus

Sarzana, Italy

Location

Hospital Angeles Clinica Londres

Mexico City, 06700, Mexico

Location

Grupo Torre Medica

México, Mexico

Location

National Institute of Neurology/Rehabilitation

México, Mexico

Location

Rehabilitation Centre

Querétaro, Mexico

Location

Perpetual Succour Hospital

Cebu City, Philippines

Location

Metropolitan Medical Center

Manila, Philippines

Location

Academy of Neurology

Krakow, Poland

Location

Bonacha

Warsaw, Poland

Location

Public Hospital Wojewodzki

Warsaw, Poland

Location

Alcoitao Rehabilitation Centre

Alcoitão, Portugal

Location

Hospital de Faro

Faro, Portugal

Location

Hospital Egas Moniz

Lisbon, Portugal

Location

Regional State Budgetary Healthcare Institution "City Hospital N°5"

Barnaul, Russia

Location

Interregional Cinical and Diagnostic Centre

Kazan', Russia

Location

Kemerovo Regional Clinical Hospital

Kemerovo, Russia

Location

Krasnoyarsks State Medical University

Krasnoyarsk, Russia

Location

Federal State Hospital for Treatment and Rehabilitation

Moscow, Russia

Location

Federal State Budgetary Institution

Saint Petersburg, Russia

Location

Pavlov First Saint-Petersburg State Medical University

Saint Petersburg, Russia

Location

China Medical University Hospital

Taichung, Taiwan

Location

Veteran General Hospital

Taipei, Taiwan

Location

Related Publications (3)

• 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.

  PMID: 34932284 DERIVED

• 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.

  PMID: 33206198 DERIVED

• 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.

  PMID: 27315835 DERIVED

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2015
• First Posted: May 27, 2015
• Study Start: January 1, 2015
• Primary Completion: June 3, 2019
• Study Completion: June 3, 2019
• Last Updated: August 5, 2019

Record last verified: 2019-08

Locations

FR (5); BR (3); US (5); AU (1); DE (5); HK (1); IT (7); PH (2); RU (7); ME (4); PL (3); PT (3); TW (2)