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 @ 12:52 AM
Ignite Modification Date:
2025-12-25 @ 12:52 AM
NCT ID:
NCT02917967
Eligibility Criteria:
Inclusion Criteria:
* Children with CP over the age of 2 years
* The spasticity is thought to interfere motor learning or cause abnormal posture and movement patterns by "management algorithm" of international consensus.
1. MAS ≥ 1+ at hamstrings
2. Dynamic spasticity rather than fixed contracture: Difference between Xv1 and Xv3 is at least 15 degrees in MTS at hamstrings
* I to III levels of GMFCS
Exclusion Criteria:
* Children who received interventions such as chemical nerve block or casting within 6 months
* Children who had baclofen pump
* Children who experienced the adverse reactions from previous BoNT-A injections
* Children who have a mixed type of CP (Athetosis, dystonia) or other movement disorder (eg. ataxia)
* Children who are participating in other investigational study at the moment
* Children who are not suitable for this study according to the investigator's discretion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
18 Years
Study:
NCT02917967
Study Brief:
Protocol Section:
NCT02917967