NCT06055725Active, not recruitingNot Applicable
A Prospective, Multicountry Study to Estimate the Incidence of and Provide a Best Practice Model for Monitoring the Development of Post-Stroke Spasticity
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Ipsen
- Enrollment
- 1,057
- Locations
- 55
- Primary Endpoint
- Percentage of participants at the Clinical Confirmation Visit (CCV) who have problematic spasticity and who the investigator considers would benefit from pharmacological therapy
Study Overview
Brief Summary
This study will monitor patients during the first year following their stroke.
Stroke is a very serious condition where there is a sudden interruption of blood flow in the brain.
The main aim of the study will be to find out how many of those who experience their first-ever stroke then go on to develop spasticity that would benefit from treatment with medication.
Spasticity is a common post-stroke condition that causes stiff or ridged muscles.
The results of this study will provide a standard guideline on the best way to monitor the development of post-stroke spasticity.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participant must be aged 18 to 90 years at the time of providing informed consent
- •First-ever clinical stroke, defined according to World Health Organization criteria as rapidly developing clinical signs of focal (at times global) disturbance of cerebral function lasting more than 24 hours, within the past 4 weeks;
- •Confirmed paresis of the arms and/or legs which does not resolve within 1 day, according to the NIHSS score (a score of > 0 on Question 5 or 6 of the scale) within 2 weeks after the stroke
- •Capable of giving informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
Exclusion Criteria
- •Upper or lower extremity functional impairment prior to stroke per investigator judgement (e.g., modified Rankin Scale >2);
- •Presence of significant/major neurological impairment that might affect muscle tone (other than limb paresis);
- •Severe multi-impairment or diminished physical condition before stroke that could have caused paresis/spasticity/motor deficit per investigator judgement;
- •Life expectancy of less than 12 months as a result of severity of stroke or other illnesses (e.g. cardiac disease, malignancy, etc.)
- •Participation in any interventional study
Outcomes
Primary Outcomes
Percentage of participants at the Clinical Confirmation Visit (CCV) who have problematic spasticity and who the investigator considers would benefit from pharmacological therapy
Time Frame: At the Clinical Confirmation Visit (CCV) up to maximum 18 months
This is based on the investigator's clinical judgement and could include spasticity characterised by any of the following criteria aligned with the World Health Organization International Classification of Functioning, Disability and Health in three dimensions: Impairment, Activity limitations \& Restriction on participation.
Secondary Outcomes
- MAS distribution of problematic spasticity at the CCV (overall and distribution by timing post-stroke)(Week 2 to Month 18)
- Distribution of National Institutes of Health Stroke Scale (NIHSS) scores(At enrollment)
- Percentage of participants who develop signs of possible spasticity(At Week 2, Month 1, Month 2, and every 3 months up to Month 12.)
- Percentage of participants who develop clinically confirmed spasticity(Week 2 to Month 14)
- Time from first ever stroke to detection of signs of possible spasticity(Week 2 to Month12)
- Time from first ever stroke to onset of clinically confirmed spasticity(Week 2 to Month 14)
- Time from first-ever stroke to onset of clinically confirmed problematic spasticity(Week 2 to Month 18)
- Description of signs of possible spasticity from the Post-stroke Spasticity Monitoring Questionnaire (PSMQ)(At Week 2, Month 1, Month 2, and every 3 months up to Month 12.)
- MAS distribution at the CCV (overall and distribution by timing post-stroke)(Week 2 to Month 14)
- Distribution of spasticity (arm/leg, unilateral/bilateral, affected muscle groups) at the CCV(Week 2 to Month 14)
- Severity of spasticity by Modified Ashworth Scale (MAS) at the CCV(Week 2 to Month 14)
- MAS distribution (overall and distribution by timing post stroke) at the CCV(At Week 2, Month 1, Month 2, and every 3 months up to Month 14.)
- Distribution of problematic spasticity (arm/leg, unilateral/bilateral, affected muscle groups) Severity of problematic spasticity by MAS at the CCV(Week 2 to Month 18)
- Distribution of 36-Item Short-form Health Survey (SF-36) quality of life questionnaire scores in participants with clinically confirmed spasticity[c] at the CCV(Week 2 to Month 14)
- Percentage of participants who develop problematic spasticity at the time of the confirmed diagnosis of spasticity at CCV(Week 2 to Month 14)
- Percentage of participants who develop problematic spasticity(At CCV and 4 months after the CCV)
- Stroke types(Week 2 to Month 14)
Investigators
Study Sites (55)
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