A Study to Estimate How Often Post-stroke Spasticity Occurs and to Provide a Standard Guideline on the Best Way to Monitor Its Development

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Multicountry Study to Estimate the Incidence of and Provide a Best Practice Model for Monitoring the Development of Post-Stroke Spasticity

Conditions
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Spasticity as Sequela of Stroke

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant must be aged 18 to 85 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants at the Clinical Confirmation Visit (CCV) who have problematic spasticity and who the investigator considers would benefit from pharmacological therapy | 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. | At the Clinical Confirmation Visit (CCV) up to maximum 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of National Institutes of Health Stroke Scale (NIHSS) scores | 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. | 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) | 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. | 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 | MAS score per joint/muscle group and MAS total score by limb | At Week 2, Month 1, Month 2, and every 3 months up to Month 14. | 
| MAS distribution of problematic spasticity at the CCV (overall and distribution by timing post-stroke) |  | Week 2 to Month 18 | 
| 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 | 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. | 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 | 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)). | Week 2 to Month 14 |