Spasticity and Treatment Satisfaction Among Stroke Survivors

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.

Full Title of Study: “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.”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 12, 2020

Clinical Trial Outcome Measures

Primary Measures

  • Degree of functional limitations in daily life activities
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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 Measures

  • Burden of spasticity/treatment
    • 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
    • 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
    • Time Frame: 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
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Investigator Details

  • Lead Sponsor
    • Ipsen
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ipsen Medical Director, Study Director, Ipsen

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