Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-25 @ 2:54 AM
NCT ID:
NCT05196633
Eligibility Criteria:
Inclusion Criteria:
* a hemorrhagic or ischemic stroke in acute, subacute or chronic phase;
* no history of previous stroke;
* lower limb post-stroke spasticity and spasticity grade ≥1 on the Modified Ashworth Scale (MAS);
* pain intensity measured on Visual Analogue Scale (VAS) ≥1;
* ability to stand unassisted in upright position for 30 seconds;
* no change in anti-spastic drug dose or treatment and no changes in analgesic medication, as it could affect the results on the Modified Ashworth Scale and the Visual Analogue Scale
* adult patients (\>18 years old)
Exclusion Criteria:
* other neurological and orthopaedic disorders or lower limb deformities that could in-terfere with motor performance and balance;
* myopathies;
* severe cognitive impairment, severe aphasia or inability to understand instructions;
* severe spasticity;
* visual field conditions or hemineglect;
* patients unable to undergo follow-up evaluation and excluded from the final analysis;
* anticoagulant medication or any contraindication to receive radial extracorporeal shockwave therapy (rESWT), or any contraindication to physical therapy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05196633
Study Brief:
Protocol Section:
NCT05196633