Functional Oral-Pharyngeal Rehabilitation of Patients With Dysphagia Using Ice-chips, a Prospective Randomized Study

Overseen By Zoltan Nemeth, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Atlantic Health System

Disqualifiers: Aphonic, Prior dysphagia, Oral thrush, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 5-10 days

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing two ways to help ICU patients who have just had a breathing tube removed to start swallowing safely again. One group will do traditional swallowing exercises, and the other group will eat small amounts of ice chips. Both methods aim to strengthen the muscles used for swallowing and help patients start eating and drinking safely sooner.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Functional Oral-Pharyngeal Rehabilitation, Ice chips?

Research shows that oral and pharyngeal motor exercises can help improve swallowing in people recovering from strokes and those with swallowing difficulties after cancer treatment. These exercises are part of the broader category of treatments that aim to improve swallowing function, suggesting potential benefits for similar therapies. ^{1 2 3 4 5}

Is the treatment generally safe for humans?

The research does not provide specific safety data for the treatment under the names Functional Oral-Pharyngeal Rehabilitation or Ice chips, but rehabilitation interventions for head and neck cancer survivors, which may include similar therapies, are generally considered safe and beneficial for improving swallowing and quality of life. ^{1 5 6 7 8}

How is Functional Oral-Pharyngeal Rehabilitation different from other treatments for oral and pharyngeal issues?

Functional Oral-Pharyngeal Rehabilitation is unique because it focuses on exercises and therapies that target the muscles in the mouth and throat to improve functions like swallowing and speech, especially after events like a stroke or surgery. Unlike other treatments that might use medication or surgery, this approach uses exercises and sometimes prosthetic devices to directly support and retrain the affected muscles, leading to improved function and patient satisfaction. ^{1 2 5 9 10}

Eligibility Criteria

Inclusion Criteria

Has been extubated

Is on room air, nasal cannula, or high flow oxygen

You have been on a breathing machine for more than 48 hours (about 2 days).

Exclusion Criteria

You have difficulty managing your own body fluids.

You are unable to speak.

You have a history of difficulty swallowing.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Participants receive a Clinical Dysphagia Evaluation and a Fiberoptic Endoscopic Evaluation of Swallowing (FEES) by a Speech-Language Pathologist

1 day

1 visit (in-person)

Treatment

Participants are randomly assigned to Group A or B. Group A receives traditional dysphagia exercises, while Group B consumes ice chips with supervision, both three times a day.

5-10 days

Daily in-person sessions

Follow-up

Participants are monitored for the return of swallowing function, assessed by FEES or barium swallow study

1-2 weeks

Treatment Details

Interventions

• Functional Oral-Pharyngeal Rehabilitation
• Ice chips

Participant Groups

Group I: Group B - Ice Chip Treatment Experimental Treatment 1 Intervention

Group B will serve as the experimental group. In place of traditional dysphagia exercises, participants in Group B will receive oral hygiene and will consume small amounts of ice chips with supervision, three times a day. The ice chip protocol is based on the same findings as the Frazier Free Water Protocol, in that small amounts of clean water or ice chips are not harmful to the lungs and relatively benign if aspirated. Ice chips provide additional advantages in rehabilitating dysphagia as they are a cohesive bolus that are easier for patients with severe dysphagia to control in their mouth and swallow.

Group II: Group A - Standard Dysphagia Treatment Active Control 1 Intervention

Group A will serve as the control group. This group will receive oral hygiene followed by traditional dysphagia exercises, including effortful swallow, Masako Maneuver, and Tongue Press.

Who Is Running the Clinical Trial?

Atlantic Health System

Lead Sponsor

Trials

58

Recruited

9,400+

Findings from Research

The modified jaw opening exercise (MJOE) was found to be safe and feasible for post-stroke patients with dysphagia, with no reported pain during the exercise regimen.

After six weeks of MJOE, participants showed significant improvements in hyoid displacement during swallowing, indicating its effectiveness in enhancing swallowing function compared to a control exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proposal for a Modified Jaw Opening Exercise for Dysphagia: A Randomized, Controlled Trial. Koyama, Y., Sugimoto, A., Hamano, T., et al.[2017]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect of Intensive Oropharyngeal Training on Radiotherapy-Related Dysphagia in Nasopharyngeal Carcinoma Patients. [2022]

2. England pubmed.ncbi.nlm.nih.gov

The role of oral and pharyngeal motor exercises in post-stroke recovery: A scoping review. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Behavioural Interventions in People with Oropharyngeal Dysphagia: A Systematic Review and Meta-Analysis of Randomised Clinical Trials. [2022]

4. Brazil pubmed.ncbi.nlm.nih.gov

Analysis of the level of Dysphagia, anxiety, and nutritional status before and after speech therapy in patients with stroke. [2020]

5. Japan pubmed.ncbi.nlm.nih.gov

Proposal for a Modified Jaw Opening Exercise for Dysphagia: A Randomized, Controlled Trial. [2017]

6. England pubmed.ncbi.nlm.nih.gov

A scoping review of rehabilitation interventions for survivors of head and neck cancer. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Management of isolated cricopharyngeal dysfunction: systematic review. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

The effect of nasopharyngoscopic biofeedback in patients with cleft palate and velopharyngeal dysfunction. [2009]

9. United States pubmed.ncbi.nlm.nih.gov

Prosthetic functional therapy. A new method for rehabilitation of the orally handicapped patient. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

The dental prosthesis used for intraoral muscle therapy in the rehabilitation of the stroke patient. A preliminary research study. [2016]