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Search / Trial NCT06311526

Mechanism of Action of Focal Extracorporeal Shock Waves as a Treatment of Upper Limb Stroke Spasticity: a Pilot Study

Launched by ISTITUTO AUXOLOGICO ITALIANO · Mar 8, 2024

Trial Information

Current as of July 25, 2025

Recruiting

Keywords

Spasticity Stroke Extracorporeal Shockwave Therapy Stroke Upper Limb Impairment Neurophysiology Musculoskeletal Ultrasound

ClinConnect Summary

This clinical trial is exploring a new treatment for spasticity in the arms that can occur after a stroke. Spasticity makes muscles stiff and can make daily activities like eating and dressing difficult and painful. The study is looking at a therapy called focal extracorporeal shock wave therapy, which uses sound waves to help improve muscle function. The researchers want to understand how these shock waves work—whether they change the physical properties of the muscles or affect how the nervous system controls the muscles.

To participate, individuals must be over 18 years old, have had their first stroke at least six months ago, and experience moderate spasticity in their arm muscles. They should not have received any botulinum toxin treatments in the past six months. During the trial, participants will receive shock wave therapy and may see improvements in muscle stiffness and movement. The study is currently recruiting and aims to provide more information on how this treatment can help those with stroke-related spasticity.

Gender

ALL

Eligibility criteria

  • Inclusion criteria
  • age \> 18 years
  • first hemispheric stroke at least six months ago
  • spasticity of wrist and elbow flexors muscles with grade 1 to 3 of the Modified Ashworth Scal
  • no botulinum toxin injection in the previous six months
  • ability to give informed consent
  • Exclusion criteria
  • anticoagulant medicine
  • presence of a pacemaker, an implantable cardioverter defibrillator or other medical devices
  • active cancer
  • skin lesions at the site of shock wave administration
  • an major neurological disease in addition to the hemiparesis (e.g. spastic hemiparesis in a patient who had Parkinson's disease before their stroke).

About Istituto Auxologico Italiano

Istituto Auxologico Italiano is a prominent Italian research institute dedicated to advancing medical science and improving patient care through innovative clinical research. With a strong focus on metabolic diseases, cardiovascular health, and neuropsychological disorders, the institute integrates clinical practice with cutting-edge research to foster the development of new therapeutic strategies. Committed to ethical standards and patient safety, Istituto Auxologico Italiano collaborates with various national and international partners, contributing significantly to the global medical community while ensuring high-quality care and support for its patients.

Locations

Milano, Mi, Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported