NCT07119801 Clinical and Ultrasonographic Evaluation of the Efficacy of Extracorporeal Shock Wave Therapy (ESWT) in Post-Stroke Spasticity
| NCT ID | NCT07119801 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pamukkale University |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2025-09-05 |
| Primary Completion | 2026-04-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 32 participants in total. It began in 2025-09-05 with a primary completion date of 2026-04-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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)
Contact & Investigator
Meltem Güneş Akıncı, Assistant professor
STUDY DIRECTOR
Pamukkale University
Frequently Asked Questions
Who can join the NCT07119801 clinical trial?
This trial is open to participants of all sexes, aged 35 Years or older, up to 65 Years, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07119801 currently recruiting?
Yes, NCT07119801 is actively recruiting participants. Contact the research team at meltem_aytekin@hotmail.com for enrollment information.
Where is the NCT07119801 trial being conducted?
This trial is being conducted at Denizli, Turkey (Türkiye).
Who is sponsoring the NCT07119801 clinical trial?
NCT07119801 is sponsored by Pamukkale University. The principal investigator is Meltem Güneş Akıncı, Assistant professor at Pamukkale University. The trial plans to enroll 32 participants.
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