Effect of ESWT Applied After Botulinum Toxin Injection on Ankle Spasticity in Stroke Patients. (NCT06126523) | Clinical Trial Compass
UnknownNot Applicable
Effect of ESWT Applied After Botulinum Toxin Injection on Ankle Spasticity in Stroke Patients.
Turkey (Türkiye)30 participantsStarted 2023-12-01
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient Evaluation Form
Timeframe: BEFORE TREATMENT
2
Modified Ashworth Scale (MAS)
Timeframe: BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT
3
Modified Tardieu Scale (MTS)
Timeframe: BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT
4
10m walking test
Timeframe: BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT
5
Timed Up and Go Test
Timeframe: BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT
6
Timed sit and stand test
Timeframe: BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT