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Effect of ESWT Applied After Botulinum Toxin Injection on Ankle Spasticity in Stroke Patients.

NCT06126523 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-12-26

No results posted yet for this study

Summary

Stroke is the second most common cause of death and the third most important cause of disability worldwide, with an annual death rate of 5.5 million. Spasticity is a common condition in stroke patients and has a negative impact on daily living activities. BTX-A has been successfully used in the treatment of spasticity in patients with stroke. ESWT is a physical therapy method applying high intensity pressure waves.

ESWT has been increasingly used in the management of spasticity as a safe and effective method, but the literature about ESWT in spasticity is heterogeneous and the treatment protocols are not very clear about the number of applications.

The aim of this study is to determine the effects of rESWT treatment on ankle plantar flexors spasticity applied after BTX-A injection.

Conditions

  • Stroke
  • Spasticity as Sequela of Stroke

Interventions

DEVICE

Radial Extracorporeal Shock Wave Therapy ONCE

rESWT application ONCE The points where rESWT will be applied will be determined under ultrasonography guidance. The pressure pulses will be focused on the injection site in the medial and lateral heads of the gastrocnemius muscle and the soleus muscle. Number of pulses: 1500 pulses Frequency: 6 Hz Energy level/Pressure: 2.2 bar air pressure Duration: 12 minutes Device to be used in research ELMED VIBROLITH ESWT SW. Give. 3.3 It is based on the principle that currents produced outside the body spread in the tissue in the form of sound waves.

DEVICE

Radial Extracorporeal Shock Wave Therapy TWİCE

rESWT application TWİCE The points where rESWT will be applied will be determined under ultrasonography guidance. The pressure pulses will be focused on the injection site in the medial and lateral heads of the gastrocnemius muscle and the soleus muscle. A total of 2 sessions of rESWT will be applied on the same day after BTX-A injection and on the 7th day after BTX-A. Number of pulses: 1500 pulses Frequency: 6 Hz Energy level/Pressure: 2.2 bar air pressure Duration: 12 minutes Device to be used in research ELMED VIBROLITH ESWT SW. Give. 3.3 It is based on the principle that currents produced outside the body spread in the tissue in the form of sound waves.

DEVICE

Radial Extracorporeal Shock Wave Therapy SHAM

Radial Extracorporeal Shock Wave Therapy- SHAM The points where rESWT will be applied will be determined under ultrasonography guidance. The pressure pulses will be focused on the injection site in the medial and lateral heads of the gastrocnemius muscle and the soleus muscle. Sham ESWT will be administered with the r-ESWT probe. The device will be switched on, the frequency, pressure and duration values will be set and then the device will be switched off and the probe will be kept in equal time with the active treatment, by playing a sound previously recorded during the real application.

Sponsors & Collaborators

  • Saglik Bilimleri Universitesi

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2024-02-26
Completion
2024-03-01

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06126523 on ClinicalTrials.gov