Exploring the time to onset and early predictors of Post-stroke spasticity combined with surface electromyography (sEMG): study protocol for a nested case-control (Preprint)

Abstract

Post-stroke spasticity (PSS) is a frequent sequela in patients who have suffered a stroke. This form of paralysis is more prevalent compared to other post-stroke sequelae and is among the most challenging and complex symptoms to manage. Surface electromyography (sEMG) can reflect the physiological information of muscles in real time and is highly beneficial in diagnosing neuromuscular diseases in clinical medicine. This study aimed to investigate the timing of post-stroke limb spasms using a nested case-control study combined with sEMG and to identify and predict factors of PSS at an early stage.

This clinical study aimed to improve the prognosis of patients with PSS by exploring the time of PSS occurrence through a nested case-control study, early identification, and prediction of PSS factors.

This was a nested case-control study. Participants were assessed within 24 h of the onset of hospitalization using a standardized case report form to evaluate general patient information and clinical data related to cerebral infarction and imaging. Upon inclusion, patients were assessed after 1, 2, 4, 8, and 12 weeks, using the Modified Ashworth Scale (MAS) for spasticity severity, root mean square (RMS) values from (sEMG) for limb spasm severity, and the simplified Fugl-Meyer Assessment (S-FM) for limb motor function. Patients who experienced spasticity within 12 weeks were assigned to the spasticity group, whereas those who did not experience spasticity were assigned to the control group. Unmatched case grouping was implemented. Data with normal distribution was analyzed using the t-test, while data with non-normal distribution was analyzed using the rank-sum test; categorical data was analyzed using the chi-square test, rank-sum test, or Fisher's exact test. Logistic regression analysis was used to investigate factors affecting treatment outcomes. Data processing, analysis, and visualization were conducted using Statistical Package for the Social Sciences software (version 26.0).

The patient is still being recruited

The patient is still being recruited

Ethics and dissemination: The study has been approved by the Ethics Committee of the Affiliated Hospital of Hunan Academy of Traditional Chinese Medicine (approval number: [202371]). All patients were required to provide a written informed consent before enrollment. The findings of this investigation were mandated for publication in peer-reviewed journals. Clinical trial registration: ClinicalTrials.gov ChiCTR2300077121.