Accepted for/Published in: JMIR Research Protocols
Date Submitted: Nov 25, 2025
Open Peer Review Period: Nov 25, 2025 - Jan 20, 2026
Date Accepted: Jul 30, 2026
(closed for review but you can still tweet)
Effects of Different Numbers of Stimulations in Single-Session Radial Extracorporeal Shockwave Therapy on Spasticity Improvement in Individuals With Subacute Hemiparetic Stroke: Protocol for a Pilot Randomized Controlled Trial
ABSTRACT
Background:
Radial extracorporeal shockwave therapy (rESWT) is effective for treating lower-limb spasticity after stroke. The effect of stimulation numbers in single-session rESWT on improving spasticity in subacute hemiparetic stroke remains unclear.
Objective:
We aim to clarify the effect of rESWT stimulation numbers on spasticity improvement and assess the feasibility of the evaluation and treatment procedures in subacute stroke.
Methods:
This single-center, open-label, pilot, randomized controlled trial will enroll 24 individuals with subacute stroke and spasticity, who will be randomly assigned to either the rESWT 3,000- or the 6,000-stimulation group for one treatment at the triceps surae muscle, with stimulation applied at three locations: the medial and lateral heads of the gastrocnemius muscle and the triceps surae muscle–Achilles tendon junction. The stimulation intensity will be the maximum intensity tolerated by the individual (≤3.0 bar), with a 10-Hz fixed frequency. Evaluations will be performed the day before treatment; immediately before and after treatment; at 1 and 8 h post-treatment; and at 1, 2, 3, 5, 7, and 14 days post-treatment. The primary clinical outcome is the intergroup difference in the Modified Ashworth Scale (MAS) score of the triceps surae immediately after treatment. Secondary clinical outcomes include intergroup differences in MAS scores at 1 and 8 h and on days 1, 2, 3, 5, 7, and 14 post-treatment, as well as intragroup differences from baseline to each evaluation point. Additional measures include the range of motion, angle of catch, tendon reflexes, and clonus scores. Safety will be assessed by recording the occurrence of serious and treatment-related adverse events.
Results:
This study was approved by the Fujita Health University Institutional Review Board on September 26, 2024 (CR24-033) and registered in the Japan Registry of Clinical Trials on October 4, 2024 (jRCTs042240098). Participant enrollment commenced on November 19, 2024 and, as of November 25, 2025, 14 participants have been enrolled. Data analysis has not commenced, and the results will be reported, in 2026, in a separate article.
Conclusions:
This pilot study provides the first evidence that the number of stimulations delivered in a single session of radial extracorporeal shockwave therapy may influence short-term improvements in spasticity after subacute hemiparetic stroke, with detailed temporal assessments and multidimensional measures suggesting potential effects on both neural and non-neural components. However, given the single-center, open-label design, these findings should be interpreted with caution and validated in larger, controlled studies. Clinical Trial: jRCTs042240098
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.