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 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT05384951
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with cerebral palsy
* Spastic or mixed tone
* GMFCS Level I-III (i.e., ambulatory)
* 13-17 years old
* Physical training level expected to remain relatively constant over the study period
* Ability to follow directions, including swallowing multiple pills daily and complying with reproductive risk recommendations (post-menarchal females)
* Within reasonable driving distance to the University of Minnesota - Twin Cities
* Reads English
Exclusion Criteria:
* Pregnant, lactating, or trying to become pregnant
* Surgery in the past 9 months
* Botulinum toxin injections in past 3 months
* Selective dorsal rhizotomy in the past 12 months
* Upcoming invasive treatment within the study period that may affect strength or functional mobility (e.g., surgery, botulinum toxin injections, intrathecal baclofen pump or dosage change)
* Liver disease or liver disorder
* Kidney disease or disorder
* Prescription drug or nutrition supplement contraindications
* Excessive research or medical-related radiation exposure in the past 12 months (approximately 500 mrem or greater)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
17 Years
Study:
NCT05384951
Study Brief:
Protocol Section:
NCT05384951