Attainment of Person-centred Goals After Botulinum Toxin Treatment for Upper Limb Spasticity in Real Life Practice
- Conditions
- Upper Limb Spasticity
- Registration Number
- NCT02454803
- Lead Sponsor
- Ipsen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1004
- 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.
- 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- Patient has already been included in the current study, but was subsequently withdrawn.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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patient centred goal attainment will be assessed using the cumulated Goal Attainment Scale Total Score (GAS T score). 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.
- Secondary Outcome Measures
Name Time Method To document the baseline patient characteristics and disease history. 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.
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) Using Goal Attainment Scaling Evaluation of Intensity (GASeous) and standardised outcome measures.
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) Assessed using the cumulated GAS T score of all goals assessed within each goal area.
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) Evaluation of change from baseline in the four domains of Disability Assessment Scale (DAS) as well as in the Principal Target of Treatment (PTT). 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.
Evolution of quality of life 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).
Health economic 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.
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) BoNT-A injection practices, concomitant drug and non-drug therapies.
Trial Locations
- Locations (57)
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
Gaitlal-Klinik Hermagor
🇦🇹Hermagor, Austria
Hospital Egas Moniz
🇵🇹Lisboa, Portugal
Krasnoyarsks State Medical University
🇷🇺Krasnoyarsk, Russian Federation
Veteran General Hospital
🇨🇳Taipei, Taiwan
Federal State Hospital for Treatment and Rehabilitation
🇷🇺Moscow, Russian Federation
Metropolitan Medical Center
🇵🇭Manila, Philippines
Academy of Neurology
🇵🇱Krakow, Poland
Regional State Budgetary Healthcare Institution "City Hospital N°5"
🇷🇺Barnaul, Russian Federation
Bonacha
🇵🇱Warsaw, Poland
Pavlov First Saint-Petersburg State Medical University
🇷🇺Saint Petersburg, Russian Federation
China Medical University Hospital
🇨🇳Taichung, Taiwan
Alcoitao Rehabilitation Centre
🇵🇹Alcoitao, Portugal
Hospital de Faro
🇵🇹Faro, Portugal
Rehabilitation Institute of Chicago
🇺🇸Chicago, Illinois, United States
Design Neuroscience
🇺🇸Doral, Florida, United States
Wake Forest School of Medicine
🇺🇸Winston-Salem, North Carolina, United States
Kansas City Bone & Joint Clinic
🇺🇸Overland Park, Kansas, United States
St Vincent's Hospital
🇦🇺Darlinghurst, Australia
Epworth Rehabilitation Camberwell
🇦🇺Camberwell, Australia
Austin Health Hospital
🇦🇺Heidelberg, Australia
Prince of Wales Hospital
🇦🇺Randwick, Australia
Liverpool Brain Injury Rehabilitation Unit
🇦🇺Liverpool, Australia
Royal Melbourne Hospital
🇦🇺Parkville, Australia
Centre Régional de Rééducation et Réadaptation Fonctionnelle
🇫🇷Angers, France
CHU Pellegrin
🇫🇷Bordeaux, France
Hospital dos Clinicas Universitaria de Sao Paulo
🇧🇷Sao Paulo, Brazil
Princess Alexandra Hospital
🇦🇺Woolloongabba, Australia
Fundacao Faculdade Regional de Medicina
🇧🇷São José do Rio Preto, Brazil
Westmead Hospital
🇦🇺Westmead, Australia
Hôpital Raymond Poincaré
🇫🇷Garches, France
CHU Grenoble Hôpital Sud
🇫🇷Grenoble, France
Institut Universitaire de Réadaptation de Clémenceau
🇫🇷Strasbourg, France
Universitaets-Klinikum Erlangen
🇩🇪Erlangen, Germany
Universitaetsklinikum Leipzig
🇩🇪Leipzig, Germany
Schoen Klinik Muenchen Schwabing
🇩🇪Munich, Germany
Klinikum rechts der Isar der Technischen Universitaet Muenchen
🇩🇪Munich, Germany
Universitaetsklinikum Wuerzburg
🇩🇪Wuerzburg, Germany
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
🇮🇹Ancona, Italy
Azienda Ospedaliero Universitaria Consorziale Policlinico
🇮🇹Bari, Italy
Azienda Ospedaliero Universitaria di Ferrara
🇮🇹Ferrara, Italy
Ospedale Valduce - Villa Beretta
🇮🇹Costa Masnaga, Italy
Fondazione Santa Lucia, I.R.C.C.S.
🇮🇹Roma, Italy
Azienda Ospedaliero Universitaria Policlinico "G Martino"
🇮🇹Messina, Italy
Fondazione Don Carlo Gnocchi Onlus
🇮🇹Sarzana, Italy
Hospital Angeles Clinica Londres
🇲🇽Ciudad de México, Mexico
National Institute of Neurology/Rehabilitation
🇲🇽Mexico, Mexico
Grupo Torre Medica
🇲🇽Mexico, Mexico
Perpetual Succour Hospital
🇵🇭Cebu City, Philippines
Public Hospital Wojewodzki
🇵🇱Warsaw, Poland
Interregional Cinical and Diagnostic Centre
🇷🇺Kazan, Russian Federation
Kemerovo Regional Clinical Hospital
🇷🇺Kemerovo, Russian Federation
Federal State Budgetary Institution
🇷🇺Saint-Petersburg, Russian Federation
Hospital de Clinicas da UFPR
🇧🇷Curitiba, Brazil
RPAH
🇦🇺Sidney, Australia
Rehabilitation Centre
🇲🇽Queretaro, Mexico
Tung Wah Hospital
🇭🇰Hong Kong, Hong Kong