Spasticity as Sequela of Stroke
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Ipsen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of functional limitations in daily life activities | monthly for 12 Weeks, or until end of injection cycle whichever occurs first | 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 |
| Health status in subjects with post-stroke spasticity | weekly for 12 Weeks, or until end of injection cycle whichever occurs first | 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 |
| Severity of Pain | 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Burden of spasticity/treatment | 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 | 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 |
| Patients' satisfaction | weekly for 12 weeks or until end of injection cycle whichever occurs first. Opening and closing interview will also explore this | Subjects Report of Satisfaction with Treatment and their perception/desire of more tailored treatment options |
| Comparison of feedback between caregivers and stroke survivors | opening ( before week 1) and ending ( 2 weeks after end of injection cycle) qualitative interviews | Agreement between the themes elicited from semi-structured interviews between caregivers and subjects |
Countries
France
Outcome results
None listed