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 @ 4:29 AM
Ignite Modification Date:
2025-12-25 @ 4:29 AM
NCT ID:
NCT06785220
Eligibility Criteria:
Inclusion Criteria:
* 1\. Confirmed diagnosis of spastic cerebral palsy (CP) by a qualified medical professional.
2\. Participants aged 3 to 7 years, as this is a common demographic affected by spastic CP.
3\. Clinical diagnosis of dysphagia, confirmed by a speech-language pathologist or related healthcare provider.
4\. No recent significant changes in neurological status or medical condition within the last six months.
5\. Sufficient cognitive ability to follow simple instructions during therapy sessions, as assessed by a qualified professional.
6\. Parental or guardian consent obtained for participants under 18, along with assent from participants when appropriate.
7\. No recent (within the last three months) oral motor therapy interventions that could confound results.
8\. Willingness and ability of the participant to engage in therapy sessions consistently.
9\. Clearance from a physician to participate in oral motor therapy and related interventions.
Exclusion Criteria:
* 1\. Diagnosis of other neurological disorders or conditions that may affect swallowing or motor skills.
2\. Serious medical conditions or comorbidities that could interfere with therapy (e.g., severe respiratory issues).
3\. Any surgical interventions affecting the oral or pharyngeal region within the last year.
4\. Concurrent participation in other clinical trials or interventions that could affect swallowing outcomes.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
7 Years
Study:
NCT06785220
Study Brief:
Protocol Section:
NCT06785220