Spasticity and Treatment Satisfaction Among Stroke Survivors

Completed

• Conditions: Spasticity as Sequela of Stroke

• Registration Number: NCT03995524
• Lead Sponsor: Ipsen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-29
• Study First Submitted QC: 2019-06-19
• Study First Posted: 2019-06-24
• Study Start: 2019-07-20
• Status Verified: 2020-05
• Primary Completion: 2020-05-12
• Study Completion: 2020-05-12
• Last Update Submitted: 2020-05-29
• Last Update Posted: 2020-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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".
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

Secondary Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Ipsen Central Contact; 🇫🇷 Paris, France