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 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT02839733
Eligibility Criteria:
* INCLUSION CRITERIA:
For all subjects:
1. Ages 5-25 inclusive
2. Able to follow the study protocol
3. Able to attend or perform the training sessions as scheduled
Additional criteria for subjects with CP:
1. Diagnosis of cerebral palsy
2. Gross Motor Functional Classification Scale Level I-II (able to walk at least 10 meters without an assistive device)
EXCLUSION CRITERIA:
For all subjects:
1\. Presence of an injury or other medical condition (besides CP) that would affect motor function or the ability to perform the motor training program.
Additional criteria for subjects with CP:
1. Less than 6 months after major surgery to their legs
2. Currently taking levodopa, trihexyphenidyl, methylphenidate or baclofen since these may affect dopamine transmission or neuroplasticity.
Additional criteria for those with CP who choose to have an MRI:
1\. Have any of the following contraindications to having an MRI scan:
1. Pregnancy
2. A ventriculo-peritoneal shunt
3. Have claustrophobia and not comfortable in small enclosed spaces
4. Have metal that would make an MRI scan unsafe such as: cardiac pacemaker, insulin infusion pump, implanted drug infusion devise, cochlear or ear implant, transdermal medication patch (nitroglycerine), any metallic implants or objects, body piercing that cannot be removed, bone or joint pin, screw, nail, plate, wire sutures or surgical staples, shunts, cerebral aneurysms clips, shrapnel or other metal embedded (such as from war wounds or accidents or previous work in metal fields or machines that may have left any metallic fragments in or near your eyes).
5. Excessive startle reaction to or fear of loud noises
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
25 Years
Study:
NCT02839733
Study Brief:
Protocol Section:
NCT02839733