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 @ 12:17 AM
Ignite Modification Date:
2025-12-25 @ 12:17 AM
NCT ID:
NCT06840158
Eligibility Criteria:
Inclusion Criteria:
All patients were checked for compliance with the following inclusion criteria:
* Written and dated Informed consent of the child's parent to participate in the clinical trial; The age of the child is from 2 to 12 years (2 years 0 months 0 days - 11 years 11 months 29 days);
* Focal spasticity associated with dynamic foot deformity of the "horse foot" type due to spasticity in children with cerebral palsy undergoing outpatient treatment;
* The degree of spasticity on the modified Ashworth scale (MAS) 2 or more;
* Grade level on the scale of basic motor functions for cerebral palsy, extended and refined version (GMFCS - E\&R) I - III;
* Children and their parents who are able to fulfill the requirements of the Protocol (i.e., fill out a self-observation diary, come to control visits).
Exclusion Criteria:
During the study, patients were excluded if any of the following criteria were present:
* Withdrawal of Informed consent by the patient's parent;
* Serious adverse events or adverse events that do not meet the criteria of severity, in the development of which, in the opinion of the researcher, further participation in the study may be detrimental to the health or well-being of the patient;
* The need for procedures and/or drug treatment that are not permitted by the Protocol of this study;
* The patient was included in violation of the criteria for inclusion/non-inclusion of the Protocol;
* The appearance of non-inclusion criteria during the study;
* The need for surgical intervention.
* The patient's incompetence with the examination procedures.
* Any condition of the patient that requires, in the reasonable opinion of the research physician, the withdrawal of the patient from the study;
* The patient refuses to cooperate or is undisciplined (for example, the patient does not show up for a scheduled visit without warning the researcher and/or loss of communication with the patient);
* The patient is out of observation;
* Non-compliance by the patient with the established Protocol requirements, rules of stay at the clinical base; For administrative reasons (termination of the study by the Sponsor or regulatory authorities), as well as in case of gross violations of the Protocol that may affect the results of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
12 Years
Study:
NCT06840158
Study Brief:
Protocol Section:
NCT06840158