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:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2025-12-24 @ 3:22 PM
NCT ID:
NCT04090892
Eligibility Criteria:
Inclusion Criteria:
* Scheduled for an selective percutaneous myofascial lengthening procedure,
* Between the ages of 4.0 and 20.11 years old,
* Lower extremity spasticity,
* Able to ambulate 50 feet without a rest, with or without an assistive device, and with or without ankle foot orthoses (AFOs) and
* Able to follow one step directions.
Exclusion Criteria:
* Botox injections into any lower extremity muscle within three months of the scheduled selective percutaneous myofascial lengthening procedure,
* Lower extremity orthopedic surgery within 6 months of the scheduled selective percutaneous myofascial lengthening procedure,
* Visual impairment that interferes with maintaining a straight path while ambulating,
* Uncontrolled seizure disorder
* A change in medication that affects spasticity or ability to follow one step directions within three months of the scheduled selective percutaneous myofascial lengthening procedure.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
21 Years
Study:
NCT04090892
Study Brief:
Protocol Section:
NCT04090892