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OpenTrials
Completed

NCT Number: NCT03995524

Spasticity and Treatment Satisfaction Among Stroke Survivors

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.

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Key information

Conditions

Spasticity as Sequela of Stroke

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ipsen Central Contact

Paris, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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 outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

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.

Acronym: REBOT

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 24, 2019
Registry last updated
Jun 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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