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 @ 11:20 PM
Ignite Modification Date:
2025-12-24 @ 11:20 PM
NCT ID:
NCT05722756
Eligibility Criteria:
Inclusion criteria:
* CCD (central coordination disorders) diagnosis based on the paediatrician's opinion with a decision that the child needs rehabilitation;
* a score of 8- 10 on the APGAR scale in the first minute of life;
* no major birth defects documented that can push the diagnosis into the diagnosis of genetic disorders;
* the age of the child at the time of the assessment of its eligibility for rehabilitation: 1-6 months (of life), calculated based on completed months of life;
* available information regarding an abnormal result of the Vojta test, defined as at least 6 abnormal reactions (marked as abnormal \[AN\], or delayed \[OP\] in the test report) with abnormal muscle tension, which indicates moderate to severe CCD;
* available information regarding the first medical examination (during the first visit (W0)), and a follow-up visit after 6 months (W6) on the determined date, maintaining the defined timeframe (5.5-6 months after W0).
Exclusion criteria (medical history was excluded from the analysis even if one of the following exclusion criteria was met):
* children who obtained a score of \< 8 points on the APGAR scale in the first minute of life;
* suspicion of any major (significant) birth defect, congenital defect syndrome (e.g. Down syndrome, Sotos syndrome) and/or indications for consultation at Genetics Clinic based on paediatric records;
* age \< 1 month or \> 6 months;
* \< 6 abnormal reactions during the Vojta test at the first eligibility visit, which indicates mild or very mild CCD.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Month
Maximum Age:
6 Months
Study:
NCT05722756
Study Brief:
Protocol Section:
NCT05722756