Effect of ESWT Applied After Botulinum Toxin Injection on Ankle Spasticity in Stroke Patients.
NCT ID: NCT06126523
Last Updated: 2023-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
30 participants
INTERVENTIONAL
2023-12-01
2024-03-01
Brief Summary
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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.
Detailed Description
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Patients who meet the inclusion criteria for the study will be seperated into three groups with the randomizer.org randomization program.
Group I: A single session of rESWT will be applied on the same day after BTX-A injection.
Group II: 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 injection.
Group III: A single session of placebo rESWT will be applied after BTX-A injection.
BTX-A injections to gastrocnemius and soleus muscles will be performed under ultrasonography guidance. rESWT will be applied to the injection points in gastrocnemius and soleus muscles.
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) Patients will be evaluated by the same researcher before treatment, 2 weeks after treatment, 1 month after treatment and 3 months after treatment.
Patients will be evaluated using the Modified Ashworth Scale, Modified Tardieu Scale, Visual Analog Scale, 10 m walk test, Timed Up and Go Test, Timed Sit and Go Test, Barthel Activities of Daily Living Index, Functional Ambulation Scale, Brunnstrom Staging.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ESWT once
A single session of rESWT will be applied on the same day after BTX-A injection.
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.
ESWT twice
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.
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.
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.
Sham ESWT
A single session of placebo rESWT will be applied after BTX-A injection.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* Patients with ankle plantar flexor spasticity MAS score \> 1 and patients who received BTX-A injection due to spasticity
* Stroke history of at least 3 months
Exclusion Criteria
* Compared to the unaffected side; More than 50% reduction in dorsiflexion range of motion of the affected side
* Dynamic ankle contracture
* Affected side lower extremity surgery in the last 12 months
* Having Botox or phenol application to the affected gastrocnemius in the last 3 months
* Change in the dose of antispastic medication used in the last 3 months
* Infection/wound in the affected lower extremity
* Contraindications for ESWT (pregnancy, cancer, bleeding disorders, inflammatory disease, pacemakers or other electronic implants).
* Significant muscle atrophy or fibrosis of the target muscle (Heckmatt scale III and IV)
18 Years
75 Years
ALL
No
Sponsors
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Saglik Bilimleri Universitesi
OTHER
Responsible Party
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Zeynep Selimoğlu Ayneli
Lecturer PHD
Locations
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SaglikBilimleriU
Istanbul, , Turkey (Türkiye)
Countries
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Other Identifiers
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ZSAYNELI
Identifier Type: -
Identifier Source: org_study_id