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

NCT06126523 | Unknown

• 1 other identifier: ZSAYNELI
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

spasticity; ESWT; Botulinum Toxin

Outcome Measures

Primary Outcomes (8)

• Patient Evaluation Form

  Demographic information, stroke history, and medications used by all stroke patients included in the study will be recorded.

  BEFORE TREATMENT

• Modified Ashworth Scale (MAS)

  It is a method used to determine the severity of spasticity. It is based on the subjective rating of the resistance felt during the examination Modified Ashworth Scale is graded between 0 and 4 points. 0: No increase in muscle tone, 4: affected part is rigid in flexion or extension. It means that the higher the score the patient receives, the higher the degree of spasticity.

  BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT

• Modified Tardieu Scale (MTS)

  The severity of muscle tone is evaluated at different determined speeds. The first angle at which an increase in resistance is detected in the joint is recorded. The range of motion is compared with the angle at completion.The minimum value in evaluating the joint angle is 0 degrees.The maximum value varies depending on the patient's joint.Higher angle value means worse result. Modified Tardieu Scale is rated between 0 and 5 points. 0: no resistance during passive motion, 5: The joint can not be moved. It means that the higher the score the patient receives, the higher the degree of spasticity.

  BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT

• 10m walking test

  Subjects are asked to walk at maximum speed in a 10-meter corridor. The time it takes them to complete the distance is measured in seconds with a stopwatch. The measurement is repeated three times and the average time of the three measurements is recorded.

  BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT

• Timed Up and Go Test

  The person is asked to get up from the chair, walk 3 meters at a safe and normal pace, turn, walk back and sit on the chair, and the time is recorded in seconds.

  BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT

• Timed sit and stand test

  It is a test that evaluates the patient's sit-to-stand activity, lower extremity strength and dynamic balance. The number of times the patient sits and stands up within 30 seconds gives the test score.

  BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT

• Barthel Activities of Daily Living Index

  It is used to measure the independence of the individual in daily living activities.

  BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT

• Functional Ambulation Scale

  It classifies individuals between 0 and 5 according to the basic motor skills required for functional ambulation.

  BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT

Secondary Outcomes (2)

• Visual Analog Scale (VAS)

  BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT

• Brunnstrom Staging

  BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT

Study Arms (3)

ESWT once

ACTIVE COMPARATOR

A single session of rESWT will be applied on the same day after BTX-A injection.

Device: Radial Extracorporeal Shock Wave Therapy ONCE

ESWT twice

ACTIVE COMPARATOR

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.

Device: Radial Extracorporeal Shock Wave Therapy ONCE; Device: Radial Extracorporeal Shock Wave Therapy TWİCE

Sham ESWT

SHAM COMPARATOR

A single session of placebo rESWT will be applied after BTX-A injection.

Device: Radial Extracorporeal Shock Wave Therapy SHAM

Interventions

Radial Extracorporeal Shock Wave Therapy ONCE DEVICE

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 once; ESWT twice

Radial Extracorporeal Shock Wave Therapy TWİCE DEVICE

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.

ESWT twice

Radial Extracorporeal Shock Wave Therapy SHAM DEVICE

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.

Sham ESWT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having an ischemic or hemorrhagic stroke, in subacute or chronic phase,
• 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

You may not qualify if:

• History of neuromuscular disease
• 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)

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

SaglikBilimleriU

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke; Muscle Spasticity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer PHD

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 13, 2023
• Study Start: December 1, 2023
• Primary Completion: February 26, 2024
• Study Completion: March 1, 2024
• Last Updated: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)