Spasticity and Treatment Satisfaction Among Stroke Survivors

Ipsen30 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Spasticity as Sequela of Stroke

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Ipsen Central Contact

Paris, France

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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".

Time frame: 12 weeks

Secondary Outcomes

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

Time frame: 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

Time frame: weekly for 12 weeks or until end of injection cycle whichever occurs first. Opening and closing interview will also explore this

Data from ClinicalTrials.gov

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