The Effects of Oral Facial Facilitation and Oral Motor Therapy in Dysphagia (NCT06785220) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Effects of Oral Facial Facilitation and Oral Motor Therapy in Dysphagia
13 participantsStarted 2025-02-01
Plain-language summary
The objective of this research is to investigate the impact of oral facial facilitation and oral motor therapy dysphagia in individuals with spastic cerebral palsy. Specifically, the study aims to:
* Evaluate changes in dysphagia and severity following a regimen of oral motor therapy and oral facial facilitation.
* Assess improvements in swallowing function, including ease of swallowing and reduction in dysphagia symptoms, after implementing oral motor therapy and oral facial facilitation.
Who can participate
Age range
3 Years – 7 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
functional oral intake scale
Timeframe: through study completion, an average of 6 months
2
Simplified dysphagia severity rating scale
Timeframe: through study completion, an average of 6 months
3
Eating Assessment Tool-10
Timeframe: through study completion, an average of 6 months