How many stroke survivors develop problematic spasticity requiring pharmacological therapy? An international (Europe and USA) observational study protocol
Introduction Current care plans for stroke survivors typically focus on acute management, resulting in many stroke survivors being discharged to their communities without adequate follow-up, despite their often experiencing significant post-stroke complications, such as post-stroke spasticity (PSS)....
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BMJ Publishing Group
2025-01-01
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| author | Pascal Maisonobe Sergiu Groppa Simon Page Richard D Zorowitz Laura Serrano Barrenechea Simon Butet David Hernández Herrero Rama Prasad Susan Sandars Seema Meloni Alessandro Picelli |
| author_facet | Pascal Maisonobe Sergiu Groppa Simon Page Richard D Zorowitz Laura Serrano Barrenechea Simon Butet David Hernández Herrero Rama Prasad Susan Sandars Seema Meloni Alessandro Picelli |
| author_sort | Pascal Maisonobe |
| collection | DOAJ |
| description | Introduction Current care plans for stroke survivors typically focus on acute management, resulting in many stroke survivors being discharged to their communities without adequate follow-up, despite their often experiencing significant post-stroke complications, such as post-stroke spasticity (PSS). While studies have explored the incidence and prevalence of PSS, little is known about how early PSS develops and how many stroke survivors develop ‘problematic’ PSS that would benefit from pharmacological treatment.Methods and analysis EPITOME is a prospective, international, observational, epidemiological study of participants (aged 18–90 years) who develop paresis within days 3–14 of a first-ever stroke that occurred within the past 4 weeks. Participants at sites across seven different countries are monitored remotely at 2 weeks and 1, 2, 3, 6, 9 and 12 months post-stroke to detect the possible onset of PSS using the Post-stroke Spasticity Monitoring Questionnaire (PSMQ). If the PSMQ indicates the possible presence of PSS, participants undergo a full in-clinic assessment to confirm the presence of PSS. For participants with confirmed PSS, the severity and distribution of spasticity is documented, and the investigator assesses whether the participant has spasticity that could benefit from pharmacological therapy. Participants without clinically confirmed PSS return to remote monitoring.Ethics and dissemination Ethics approval was obtained in all seven participating countries. Results will be published at international meetings and in an international peer-reviewed journal. Lay summaries will be prepared to accompany the primary paper and will also be provided to study participants.Trial registration number ClinicalTrials.gov NCT06055725. |
| format | Article |
| id | doaj-art-3693861e68cb4e6480eeb7603f32edd3 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-3693861e68cb4e6480eeb7603f32edd32025-01-17T23:50:09ZengBMJ Publishing GroupBMJ Open2044-60552025-01-0115110.1136/bmjopen-2024-087404How many stroke survivors develop problematic spasticity requiring pharmacological therapy? An international (Europe and USA) observational study protocolPascal Maisonobe0Sergiu Groppa1Simon Page2Richard D Zorowitz3Laura Serrano Barrenechea4Simon Butet5David Hernández Herrero6Rama Prasad7Susan Sandars8Seema Meloni9Alessandro Picelli1010 Biostatistics & Data Management, Ipsen Pharma, Boulogne-Billancourt, France4 University Medicine Mainz, Mainz, Germany9 Ipsen Group, Slough, UK1 MedStar National Rehabilitation Network and Georgetown University School of Medicine, Washington, District of Columbia, USA2 Southern Älvsborg Hospital, Borås, Sweden3 CHU Pontchaillou, Rennes, France5 La Paz University Hospital, Madrid, Spain6 Leicester General Hospital, Leicester, UK7 Different Strokes, Gloucester, UK8 Ipsen, Cambridge, Massachusetts, USA11 University of Verona, Verona, ItalyIntroduction Current care plans for stroke survivors typically focus on acute management, resulting in many stroke survivors being discharged to their communities without adequate follow-up, despite their often experiencing significant post-stroke complications, such as post-stroke spasticity (PSS). While studies have explored the incidence and prevalence of PSS, little is known about how early PSS develops and how many stroke survivors develop ‘problematic’ PSS that would benefit from pharmacological treatment.Methods and analysis EPITOME is a prospective, international, observational, epidemiological study of participants (aged 18–90 years) who develop paresis within days 3–14 of a first-ever stroke that occurred within the past 4 weeks. Participants at sites across seven different countries are monitored remotely at 2 weeks and 1, 2, 3, 6, 9 and 12 months post-stroke to detect the possible onset of PSS using the Post-stroke Spasticity Monitoring Questionnaire (PSMQ). If the PSMQ indicates the possible presence of PSS, participants undergo a full in-clinic assessment to confirm the presence of PSS. For participants with confirmed PSS, the severity and distribution of spasticity is documented, and the investigator assesses whether the participant has spasticity that could benefit from pharmacological therapy. Participants without clinically confirmed PSS return to remote monitoring.Ethics and dissemination Ethics approval was obtained in all seven participating countries. Results will be published at international meetings and in an international peer-reviewed journal. Lay summaries will be prepared to accompany the primary paper and will also be provided to study participants.Trial registration number ClinicalTrials.gov NCT06055725.https://bmjopen.bmj.com/content/15/1/e087404.full |
| spellingShingle | Pascal Maisonobe Sergiu Groppa Simon Page Richard D Zorowitz Laura Serrano Barrenechea Simon Butet David Hernández Herrero Rama Prasad Susan Sandars Seema Meloni Alessandro Picelli How many stroke survivors develop problematic spasticity requiring pharmacological therapy? An international (Europe and USA) observational study protocol BMJ Open |
| title | How many stroke survivors develop problematic spasticity requiring pharmacological therapy? An international (Europe and USA) observational study protocol |
| title_full | How many stroke survivors develop problematic spasticity requiring pharmacological therapy? An international (Europe and USA) observational study protocol |
| title_fullStr | How many stroke survivors develop problematic spasticity requiring pharmacological therapy? An international (Europe and USA) observational study protocol |
| title_full_unstemmed | How many stroke survivors develop problematic spasticity requiring pharmacological therapy? An international (Europe and USA) observational study protocol |
| title_short | How many stroke survivors develop problematic spasticity requiring pharmacological therapy? An international (Europe and USA) observational study protocol |
| title_sort | how many stroke survivors develop problematic spasticity requiring pharmacological therapy an international europe and usa observational study protocol |
| url | https://bmjopen.bmj.com/content/15/1/e087404.full |
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