Clinical Sciences/Health Conditions
Alessandro Picelli, MD
Physician
University of Verona
Verona, Veneto, Italy
Simon Page, PhD
Global Medical Affairs Director
Ipsen, London, United Kingdom
London, England, United Kingdom
Richard D. Zorowitz, MD
Physician
MedStar National Rehabilitation Network and Georgetown University School of Medicine
Washington, District of Columbia, United States
Laura Serrano Barrenechea, MD
Physician
Länssjukhuset
Ryhov, Jonkopings Lan, Sweden
Simon Butet, MD
Physician
CHU Pontchaillou
Rennes, Bretagne, France
David Hernández Herrero, MD
Physician
La Paz University Hospital
Madrid, Madrid, Spain
Rama Prasad, MD
Consultant
Leicester General Hospital
Leicester, England, United Kingdom
Pascal Lecomte, BA
Patient representative
Stroke & Go
Houyet, Brabant Wallon, Belgium
Sophie Vandenbremt, BA
Patient representative
Stroke & Go
Houyet, Brabant Wallon, Belgium
Mathieu Beneteau, BA
Biometry
Ipsen, Paris, France
Paris, Ile-de-France, France
Pascal Maisonobe, MS
Biometry
Ipsen
Paris, Ile-de-France, France
The EPITOME study (NCT06055725) evaluates how many stroke survivors with paresis develop problematic post-stroke spasticity (PSS) that may benefit from medication within one-year post-stroke. The study uses the 13-item Post-Stroke Spasticity Monitoring Questionnaire (PSMQ) for remote monitoring. This prespecified interim analysis measured predictiveness of PSMQ for spasticity detection and aimed to potentially simplify the PSMQ.
Participants (18-85y) were recruited ≤4 weeks after first-ever stroke with paresis ≤2 weeks. Participants complete the PSMQ at defined intervals up to one year. Participants whose PSMQ indicates the possible presence of spasticity (defined as a score ≥2) undergo a confirmatory assessment but continue monitoring if PSS is not clinically confirmed. For this analysis of the first 151 participants to reach month 3, all attended a clinic visit regardless of PSMQ score. Receiver operating characteristic (ROC) curve analyses evaluated which PSMQ items were most predictive of spasticity.
Of 151 participants, 99 (65.6%) had a PSMQ score of ≥2, and 69 (45.7%) had confirmed PSS. The sensitivity of the PSMQ was 81% but the specificity was 48%. ROCAUC analysis revealed item area-under-curve (AUC) in descending order: Q1 (stiffness/tightness) and Q2 (difficulty bending/flexing limb): 0.66; Q6 (symptoms >1 month): 0.61; Q10 (putting on coat): 0.60; Q9 (cleaning armpit), Q3 (spasms), Q8 (cleaning palm/fingers): 0.59; Q7 (hand clenching): 0.58; Q4 (pain): 0.56; Q13 (putting on trousers): 0.54; Q11 (toe curling/stuck): 0.52; Q5 (sleep): 0.51; and Q12 (walking): 0.50. Simplifying the PMSQ to to only Q1 and Q2 retained the predictiveness of the tool (ROCAUC of 0.69 with items 1+2 vs 0.66 with PSMQ-total score) while reducing the burden of questionnaire completion.
45.7% of stroke survivors with paresis developed PSS within one-year post-stroke. A simplified tool using only PMSQ Q1 and Q2 will be used in the study to improve monitoring while reducing patient burden.
