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:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07447934
Eligibility Criteria:
Inclusion Criteria:
* ≥6 months following neurologic diagnosis leading to spasticity
* Modified Ashworth Scale (MAS) score of 3 or lower on ankle plantar flexor.
* Ability to stand (with or without assistance) and lie supine.
* Able to understand and comply with study procedures.
Exclusion Criteria:
* Uncontrolled systemic illness or serious medical conditions that could interfere with study procedures.
* Previous surgery to treat spasticity in the affected lower limb.
* Prior Botulinum Toxin (BoNT) therapy in the target limb within 4 months.
* Unstable medication regimens for spasmolysis or muscle relaxation.
* Participation in tone-related treatments (e.g., physiotherapy, TENS, acupuncture) within 4 weeks prior to baseline. If ongoing treatment started more than 4 weeks before baseline, it should remain consistent throughout the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT07447934
Study Brief:
Protocol Section:
NCT07447934