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 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 12:05 AM
NCT ID:
NCT07007858
Eligibility Criteria:
Inclusion Criteria:
* Children aged 2 to 8 years diagnosed with cerebral palsy of the hemiplegic or diplegic type according to the Rosenbaum criteria
* Presence of spasticity in the ankle plantar flexors with a Modified Ashworth Scale (MAS) score of 1, 1+, 2, or 3, and a clinical indication for BoNT-A injection into the gastrocnemius or gastrocnemius/soleus muscles at this stage of treatment
* Gross Motor Function Classification System (GMFCS) levels of 1, 2, or 3 (ambulatory)
Exclusion Criteria:
* Having a neuromuscular disorder other than cerebral palsy
* Presence of a fixed foot deformity
* Receiving serial casting or spasticity treatments (e.g., baclofen or BoNT-A) within the past 6 months
* History of surgery
* Having intellectual or behavioral difficulties, or comorbid conditions (such as cardiac, respiratory disorders or uncontrolled seizures) that prevent safe participation in exercise
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
8 Years
Study:
NCT07007858
Study Brief:
Protocol Section:
NCT07007858