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 @ 2:29 PM
Ignite Modification Date:
2025-12-24 @ 2:29 PM
NCT ID:
NCT04524559
Eligibility Criteria:
Inclusion criteria
* Diagnosed as spastic quadrilepgic CP
* Both genders
* Aged from 12 to 48 months
* Scored ≤ 10 on an initial evaluation of Oral Motor Assessment Scale.
* Having at least a problem of oral motor functions (drooling, swallowing, and/or sucking); independent feeding
* Grade ≥ 2 spasticity according to the MAS
* Level IV and V motor function according to the GMFCS-R\&E.
* Partial head and trunk control. Exclusion criteria
* Gum and/or dental problems
* Congenital problems of mouth and soft plate
* Uncontrolled seizures
* Any metabolic disorders
* Cardiopulmonary disorders
* Significant mental problems.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Months
Maximum Age:
48 Months
Study:
NCT04524559
Study Brief:
Protocol Section:
NCT04524559