A Study to Estimate How Often Post-stroke Spasticity Occurs and to Provide a Standard Guideline on the Best Way to Monitor Its Development
- Conditions
- Spasticity as Sequela of Stroke
- Registration Number
- NCT06055725
- Lead Sponsor
- Ipsen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1051
- 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) between Day 3 and day 14 after the stroke
- Capable of giving informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of participants at the Clinical Confirmation Visit (CCV) who have problematic spasticity and who the investigator considers would benefit from pharmacological therapy 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 Outcome Measures
Name Time Method Percentage of participants who develop clinically confirmed spasticity Week 2 to Month 14 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 Participants with clinically confirmed spasticity (MAS \> 0 in any muscle group of arm and/or leg) at the CCV will be asked to complete the SF-36 health survey to assess their general health and wellbeing. The SF-36 is a generic, multipurpose short form survey consisting of 36 questions. Most of the questions are answered based on how the participant has been feeling over the previous 4 weeks.
Time from first-ever stroke to onset of clinically confirmed problematic spasticity Week 2 to Month 18 Percentage of participants who develop signs of possible spasticity At Week 2, Month 1, Month 2, and every 3 months up to Month 12. Time from first ever stroke to onset of clinically confirmed spasticity Week 2 to Month 14 Distribution of spasticity (arm/leg, unilateral/bilateral, affected muscle groups) at the CCV Week 2 to Month 14 Percentage of participants who develop problematic spasticity At CCV and 4 months after the CCV Distribution of National Institutes of Health Stroke Scale (NIHSS) scores At enrollment Including description of score for each physical item (arm and leg motor scores) and total physical item score National Institutes of Health Stroke Scale (NIHSS) is a 15-item impairment scale, intended to evaluate neurologic outcome and degree of recovery for patients with stroke. The scale assesses level of consciousness, extraocular movements, visual fields, facial muscle function, extremity strength, sensory function, coordination (ataxia), language (aphasia), speech (dysarthria), and hemi-inattention (neglect) (Lyden, Lu, \& Jackson, 1999; Lyden, Lu, \& Levine, 2001). The higher the NIHSS score the worse the outcome for the participant. If the participant has a score greater than '0' they will satisfy Inclusion Criteria number 3.
Time from first ever stroke to detection of signs of possible spasticity Week 2 to Month12 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. MAS score per joint/muscle group and MAS total score by limb
MAS distribution of problematic spasticity at the CCV (overall and distribution by timing post-stroke) Week 2 to Month 18 Percentage of participants who develop problematic spasticity at the time of the confirmed diagnosis of spasticity at CCV Week 2 to Month 14 Severity of spasticity by Modified Ashworth Scale (MAS) at the CCV Week 2 to Month 14 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. Post-stroke Spasticity Monitoring Questionnaire (PSMQ) is a modified version (in local language) of a published 13-item patient reported screening questionnaire designed as a practical, easy-to-use tool to enable health care providers to identify patients with spasticity in need of treatment in routine clinical practice. The PSMQ will have an additional (14th) question for the participant to answer only if he/she has a total score for the first 13 questions of \> 0 and has given an identical pattern of responses for any previously answered questionnaire which led to a F2F visit where a result of Modified Ashworth Scale (MAS) = 0 was obtained. The higher the PSMQ or MAS score is the worse the outcome for the participant.
MAS distribution at the CCV (overall and distribution by timing post-stroke) Week 2 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 Stroke types Week 2 to Month 14 In terms of side (Left/Right), aetiology (Ischaemic/Haemorrhagic), and Bamford/Oxford classification (Total Anterior Circulation (TAC), Partial Anterior Circulation (PAC), Lacunar syndrome (LAC), Posterior Circulation syndrome (POC)).
Trial Locations
- Locations (41)
Nottingham University Hospitals NHS Trust - Nottingham City Hospital
🇬🇧Nottingham, United Kingdom
CHU Nantes
🇫🇷Saint-Jacques, France
Neuromotor And Cognitive Rehabilitation Research Centre; Dep. Of Neurological, Neuropsychological, Morphological And Movement Sciences; Univ. Of Verona - Neurological Rehabilitation Unit- Policlinico Borgo Roma
🇮🇹Verona, Italy
Loma Linda
🇺🇸Anderson, California, United States
University Of California, Los Angeles Medical Center
🇺🇸Los Angeles, California, United States
University of South Florida (USF) - Morsani Center (USF Health Carol and Frank Morsani Center for Advanced Healthcare)
🇺🇸Florida City, Florida, United States
Emory University Merge
🇺🇸Atlanta, Georgia, United States
Medstar Health Research Institute, Inc
🇺🇸Hyattsville, Maryland, United States
Spaulding Rehabilitation Hospital
🇺🇸Boston, Massachusetts, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University of Missouri Health Care
🇺🇸Columbia, Missouri, United States
Methodist Physicians Clinic
🇺🇸Omaha, Nebraska, United States
Duke University School of Medicine
🇺🇸Durham, North Carolina, United States
Moss Rehab
🇺🇸Elkins Park, Pennsylvania, United States
The University Of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
The University of Texas Health Science Center
🇺🇸San Antonio, Texas, United States
University Of Utah
🇺🇸Salt Lake City, Utah, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
CHU Bordeaux-Hopital Pellegrin
🇫🇷Bordeaux, France
CHU de Caen
🇫🇷Caen, France
CHU de Rennes, Hopital de Pontchaillou
🇫🇷Rennes, France
Hospices Civils de Lyon (HCL) - Hopital Henry Gabrielle
🇫🇷Saint-Genis-Laval, France
Universitaetsklinikum Essen
🇩🇪Essen, Germany
Universitaetsklinikum Schleswig-Holstein, UKSH-Campus Kiel
🇩🇪Kiel, Germany
Universitaetsklinikum Schleswig-Holstein Campus Luebeck
🇩🇪Luebeck, Germany
Universitaetsmedizin der Johannes - Gutenberg Universitaet Mainz
🇩🇪Mainz, Germany
Azienda Ospedaliero Universitaria OO RR di Foggia
🇮🇹Foggia, Italy
AOU maggiore della Carita'
🇮🇹Novara, Italy
AOU San giovanni di Dio e Ruggi d'aragona Univ. di Salerno
🇮🇹Salerno, Italy
Neurological Rehabilitation Unit- Policlinico Borgo Roma.
🇮🇹Verona, Italy
Hospital Mutua De Terrassa
🇪🇸Barcelona, Spain
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Complexo Hospitalario Universitario De Vigo - Hospital Do Mexoeiro
🇪🇸Vigo, Spain
Sodra Alvsborgs Sjukhus
🇸🇪Borås, Sweden
Skane University Hospital
🇸🇪Malmö, Sweden
Karnsjukhuset Skaraborg
🇸🇪Skövde, Sweden
Angelholm Northern Hospital
🇸🇪Ängelholm, Sweden
University Hospitals of Leicester NHS Trust - Leicester General Hospital (LGH)
🇬🇧Leicester, United Kingdom
The Walton Centre
🇬🇧Liverpool, United Kingdom
South Tees Hospitals Foundation Nhs Trust
🇬🇧Middlesbrough, United Kingdom