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- Patient has already been included in the current study, but was subsequently withdrawn.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.
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) 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.
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)
Design Neuroscience
🇺🇸Doral, Florida, United States
Rehabilitation Institute of Chicago
🇺🇸Chicago, Illinois, United States
Kansas City Bone & Joint Clinic
🇺🇸Overland Park, Kansas, United States
Wake Forest School of Medicine
🇺🇸Winston-Salem, North Carolina, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
Epworth Rehabilitation Camberwell
🇦🇺Camberwell, Australia
St Vincent's Hospital
🇦🇺Darlinghurst, Australia
Austin Health Hospital
🇦🇺Heidelberg, Australia
Liverpool Brain Injury Rehabilitation Unit
🇦🇺Liverpool, Australia
Royal Melbourne Hospital
🇦🇺Parkville, Australia
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