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 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT03226860
Eligibility Criteria:
Inclusion Criteria:
* Children who are:
1. Are age 5-18 years
2. Have been walking independently (no walker or cane) for at least 18 months.
3. Use co-contraction of DF and PF during walking based upon surface electromyography.
4. Have a diagnosis of spastic hemiplegic CP, Gross Motor Function Classification System (GMFCS) Levels I-II
Exclusion Criteria:
* Children who:
1. Have passive ankle range \<5 DF or \< 10 PF with hip and knee extended.
2. Report uncontrolled seizures.
3. Had orthopedic surgery (for example heel cord or hamstring lengthening)
4. Have used tone reducing medications (Botox, Baclofen) in the last 6 months.
5. Wear ankle foot orthoses that limit DF/PF motion.
6. Have low motivation/tolerance for electrical stimulation.
7. Have parents/caregivers who are not able or willing to assist with the protocol for 6 months.
8. Have low tolerance to electrical stimulation in screening process.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
18 Years
Study:
NCT03226860
Study Brief:
Protocol Section:
NCT03226860