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

Study Overview
=================
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.

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

Conditions
-----------------
Upper Limb Spasticity

Participation Criteria
=================
Eligibility Criteria
-----------------
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 Patient has already been included in the current study, but was subsequently withdrawn.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline | 
| To document the clinical management of the upper limb spasticity. | 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. | 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. |  | 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. | 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. | 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). | 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. | From visit 1 (injection 1) and up to the end of the study (maximum 24 months after first injection) |