How many stroke survivors develop problematic spasticity requiring pharmacological therapy? An international (Europe and USA) observational study protocol

Abstract

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.

Keywords: EPIDEMIOLOGIC STUDIES; Rehabilitation medicine; Stroke.

Figure 1. Screenshots from the Post-stroke Spasticity Monitoring Questionnaire adapted for use in remote monitoring. (A) Question 1. (B) Question 2. Each item is rated on a scale from 0 (not present) to 4 (worst possible). Participants have the choice of completing their remote monitoring by telephone calls or by electronic questionnaire (by themselves or with caregiver assistance), depending on their ability to use equipment and personal preferences.

Figure 2. Operationalisation of an ICF-based definition of problematic spasticity. ICF, International Classification of Functioning, Disability and Health.