Radial Extracorporeal Shock Wave Therapy as an Adjunct to Botulinum Toxin Type A for Post-Stroke Lower Limb Spasticity (SOLUTION)

Brief summary (registry, in English)

The goal of this pilot clinical trial is to determine whether radial extracorporeal shock wave therapy (rESWT), when used as an adjunct to ultrasound-guided botulinum toxin type A (BoNT-A) injections, can enhance the therapeutic effect of BoNT-A in adults with post-stroke lower-limb spasticity. The study will also evaluate the safety and tolerability of the combined treatment. The main questions it aims to answer are: * Does the addition of active rESWT to BoNT-A result in a greater improvement in lower-limb spasticity, measured by the change in Modified Ashworth Scale score from baseline to 5 weeks after treatment? * Does adjunctive rESWT improve other measures of muscle spasticity, ankle mobility, gait performance, perceived global improvement, and pain, and is the treatment safe and well tolerated? Researchers will compare BoNT-A combined with active rESWT with BoNT-A combined with sham rESWT to determine whether the addition of active rESWT provides greater clinical benefit. Participants will: * Receive ultrasound-guided BoNT-A injections according to the study protocol. * Receive either active rESWT or sham rESWT according to their randomly assigned treatment group. * Attend scheduled follow-up visits for assessment of spasticity, ankle range of motion, gait performance, muscle length, global clinical improvement, pain, and treatment safety. * Complete the planned assessments during the follow-up period, including evaluation at 5 weeks after treatment and subsequent follow-up assessments for up to 6 months.

What you commit to

• Study type: Interventional · Early phase 1
• Participants enrolled: 20
• From 1 Feb 2024 to the primary completion date, 4 Jul 2024
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

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Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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