Actively Recruiting

Phase Not Applicable
Age: 35Years - 65Years
All Genders
NCT07119801

Clinical and Ultrasonographic Evaluation of the Efficacy of Extracorporeal Shock Wave Therapy (ESWT) in Post-Stroke Spasticity

Led by Pamukkale University · Updated on 2025-09-29

32

Participants Needed

1

Research Sites

49 weeks

Total Duration

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AI-Summary

What this Trial Is About

This research evaluate the effectiveness of Extracorporeal Shock Wave Therapy (ESWT) for treating spasticity in the wrist flexor muscles (flexor carpi ulnaris - FCU and flexor carpi radialis - FCR) of chronic stroke patients. Spasticity, a common complication after a stroke, causes muscle stiffness, pain, and functional limitation, leading to increased healthcare costs and a lower quality of life. Current treatments like medication and injections have significant drawbacks, such as side effects and high costs, creating a need for new, non-invasive, and effective methods. The study highlights that traditional methods for assessing spasticity, like the Modified Ashworth Scale (MAS), are subjective. It proposes using objective, non-invasive ultrasound techniques-specifically strain elastography (to measure muscle stiffness) and echogenicity (to assess muscle tissue quality)-for a more reliable evaluation. The primary goal of this research is to be the first to investigate the short- and long-term effects of ESWT on the FCR and FCU muscles using these objective ultrasound measures alongside traditional clinical scales. The findings are expected to help standardize ESWT treatment protocols and promote the use of objective ultrasound data for the management and follow-up of post-stroke spasticity.

CONDITIONS

Official Title

Clinical and Ultrasonographic Evaluation of the Efficacy of Extracorporeal Shock Wave Therapy (ESWT) in Post-Stroke Spasticity

Who Can Participate

Age: 35Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
  • Modified Ashworth Scale score between 1 and 3 for wrist flexor spasticity.
Not Eligible

You will not qualify if you...

  • History of more than one stroke episode.
  • Stroke onset more than ten years ago.
  • Stroke onset less than 6 months ago.
  • Age over 65 years.
  • Contraindications for ESWT such as cancer, local tumor or active infection in treatment area, pregnancy, coagulation disorders, pacemaker or other electronic/metallic implants.
  • Severe aphasia or serious communication problems.
  • Presence of fixed contracture in the wrist.
  • Received botulinum toxin or phenol nerve block injections within the last 6 months.
  • Medically unstable conditions like uncontrolled hypertension, diabetes mellitus, or severe cardiac, hepatic, or renal disease.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Pamukkale University

Denizli, Turkey (Türkiye)

Actively Recruiting

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Research Team

M

Meltem Güneş Akıncı, Assistant professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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