Spasticity and Treatment Satisfaction Among Stroke Survivors

Study Overview
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Brief Summary
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To investigate, through ethnography, changes in symptom burden and disability and their effects/interference on patient functioning, ability to perform activities of daily living (ADL) and quality of life (QoL) throughout the duration of one BoNT-A treatment cycle.

Official Title
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Perceived Spasticity and Treatment Satisfaction Among Stroke Survivors Over the Course of a Complete Treatment Cycle With Botulinum Neurotoxin A (BoNT-A): an Ethnographic Study.

Conditions
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Spasticity as Sequela of Stroke

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnostic of post-stroke spasticity more than three months prior to inclusion At least 6 months on treatment (or two treatment cycles) with BoNT-A injections for spasticity according to the decision of the physician Previous BoNT-A injection cycles did not last for more than 16 weeks Ambulatory (use of walking aids is acceptable) Exclusion Criteria: Neurological disorder other than stroke Spasticity-specific treatment changes within 3 months prior to inclusion Patients who had undergone neurolysis or surgery to the affected limb within 6 months Concurrent participation in a clinical trial for the treatment of spasticity

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of functional limitations in daily life activities | Degree of functional limitations in daily life activities (i.e. physical functioning) associated with post-stroke spasticity as assessed by using WHODAS parameters, and identification of their characteristics and changes over time | monthly for 12 Weeks, or until end of injection cycle whichever occurs first | 
| Health status in subjects with post-stroke spasticity | Health status in subjects with post-stroke spasticity as assessed by using EQ-5D-5L parameters, and identification of their characteristics and changes over time | weekly for 12 Weeks, or until end of injection cycle whichever occurs first | 
| Severity of Pain | Severity of Pain as per EQ-5D-5L and a sliding scale. This is a descriptive scale that covers 5 dimensions: mobility, self-care, usual activities,pain/discomfort and anxiety/depression. the scale consist of 5 levels, where level one corresponds to no problems and level 5 corresponds to extreme problem. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Burden of spasticity/treatment | Themes/domains related to the everyday life experiences of subjects with post-stroke spasticity (e.g. burden disease/treatment) through qualitative analysis of in-depth open-ended interviews | Opening interview and ending qualitative interviews, ethnography data which will be provided at discretion of patient/caregiver for 12 weeks or duration of treatment, whichever occurs first, may also support these qualitative analyses | 
| Patients' satisfaction | Subjects Report of Satisfaction with Treatment and their perception/desire of more tailored treatment options | weekly for 12 weeks or until end of injection cycle whichever occurs first. Opening and closing interview will also explore this | 
| Comparison of feedback between caregivers and stroke survivors | Agreement between the themes elicited from semi-structured interviews between caregivers and subjects | opening ( before week 1) and ending ( 2 weeks after end of injection cycle) qualitative interviews |