Spasticity and Treatment Satisfaction Among Stroke Survivors

NCT03995524 | Completed

• 1 other identifier: F-FR-52120-258
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Spasticity as Sequela of Stroke

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (3)

• 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

• Patients' satisfaction

  weekly for 12 weeks or until end of injection cycle whichever occurs first. Opening and closing interview will also explore this

• Comparison of feedback between caregivers and stroke survivors

  opening ( before week 1) and ending ( 2 weeks after end of injection cycle) qualitative interviews

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

40 Adults subjects (male or female) suffering from post-stroke spasticity (the US, UK, France, and Italy), who are treated with BoNT-A in the course of routine clinical practice for focal spasticity

You may qualify if:

• 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)

You may not qualify if:

• Neurological disorder other than stroke
• 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

Sponsors & Collaborators

• Ipsen: lead

Study Sites (1)

Ipsen Central Contact

Paris, France

Location

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: June 24, 2019
• Study Start: July 20, 2019
• Primary Completion: May 12, 2020
• Study Completion: May 12, 2020
• Last Updated: June 1, 2020

Record last verified: 2020-05

Locations

FR (1)