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 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 1:14 AM
NCT ID:
NCT05126693
Eligibility Criteria:
Inclusion Criteria:
* Confirmed diagnosis of spastic cerebral palsy
* Aged 4-11 years
* GMFCS levels I-III (GMFCS = Gross Motor Function Classification Score, expressing the overall functional level of impairment)
* Sufficient cooperation to comprehend and complete the test procedure
* Additional exclusion criterion for the intervention group specifically: Indication for BoNT injections
Exclusion Criteria:
* Non-ambulatory
* Botulinum toxin A injections six months prior to enrollment
* Lower limb surgery two years prior to enrollment
* Previous selective dorsal rhizotomy
* Presence of ataxia or dystonia
* Cognitive problems that impede measurements
* Severe co-morbidities (severe epilepsy, non-correctable visual impairment, autism spectrum disorders, mental problems that prevent comprehensiveness of the tasks)
* Hospitalization after the BoNT treatment for intensive physical therapy
* Intrathecal baclofen pump
* For the control group: new intervention planned within 3 months
* Additional exclusion criterion for the control group specifically: new intervention planned within 3 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
11 Years
Study:
NCT05126693
Study Brief:
Protocol Section:
NCT05126693