Shock wave therapy to reduce wrist muscle spasticity after stroke
Clinical and Ultrasonographic Evaluation of the Efficacy of Extracorporeal Shock Wave Therapy (ESWT) in Post-Stroke Spasticity: A Randomized Controlled Trial
This trial will try radial extracorporeal shock wave therapy to reduce wrist flexor spasticity in adults 35–65 who had a single stroke more than six months ago.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 35 Years to 65 Years |
| Sex | All |
| Sponsor | Pamukkale University Academic / other |
| Locations | 1 site (Denizli) |
| Trial ID | NCT07119801 on ClinicalTrials.gov |
What this trial studies
Chronic stroke patients with moderate wrist flexor spasticity will receive radial extracorporeal shock wave therapy in addition to conventional rehabilitation, and outcomes will be compared over short-term follow-up. Clinical spasticity will be measured with the Modified Ashworth Scale while ultrasound strain elastography and echogenicity will provide objective measures of muscle stiffness and tissue quality. The protocol excludes patients with fixed contractures, recent botulinum toxin or phenol injections, multiple strokes, or medical contraindications to ESWT. The study aims to correlate clinical changes with ultrasonographic biomarkers to provide more objective evidence of treatment effect.
Who should consider this trial
Good fit: Ideal candidates are adults aged 35–65, more than six months after a first-ever stroke, with wrist flexor spasticity rated MAS 1–3 and no contraindications to ESWT.
Not a fit: Patients with fixed wrist contractures, severe communication problems, multiple prior strokes, recent botulinum toxin/phenol injections, significant unstable medical conditions, or contraindications to ESWT are unlikely to benefit or to be eligible.
Why it matters
Potential benefit: If successful, ESWT could provide a noninvasive way to reduce wrist spasticity and improve comfort and function for chronic stroke survivors.
How similar studies have performed: Small trials and case series have reported reductions in post-stroke spasticity with ESWT, but larger, ultrasound-supported randomized data are limited so the approach is promising but not yet definitively proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 35 and 65 years. * First-ever stroke episode confirmed by MRI and/or CT scan. * Clinical diagnosis of hemiplegia. * More than 6 months post-stroke. * A Modified Ashworth Scale (MAS) score between 1 and 3 for wrist flexor spasticity. Exclusion Criteria: * History of more than one stroke episode * Stroke onset more than ten years ago * Stroke onset less than 6 months ago * Age over 65 (to limit the effects of aging on muscle structure) * Contraindications for ESWT (e.g., cancer, local tumor or active infection in the treatment area, pregnancy, coagulation disorders, pacemaker or other electronic/metallic implants) * Severe aphasia or serious communication problems * Presence of fixed contracture in the wrist * Patients who have received botulinum toxin or phenol nerve block injections within the last 6 months * Medically unstable patients (e.g., uncontrolled hypertension, diabetes mellitus, or severe cardiac, hepatic, or renal disease)
Where this trial is running
Denizli
- Pamukkale University — Denizli, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Meltem Güneş Akıncı, Assistant professor
- Email: meltem_aytekin@hotmail.com
- Phone: +905375145590
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.