Spasticity and Treatment Satisfaction Among Stroke Survivors

Spasticity as Sequela of Stroke Clinical Trial

— REBOT  

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03995524
• Other study ID #: F-FR-52120-258
• Status: Completed
• Start date: July 20, 2019
• Est. completion date: May 12, 2020

Study information

• Verified date: May 2020
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 12, 2020
• Est. primary completion date: May 12, 2020
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Spasticity
• Spasticity as Sequela of Stroke
• Stroke

Locations

Country	Name	City	State
France	Ipsen Central Contact	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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