Wearable Biofeedback for Swallowing Disorders

Overseen By Shelley Reichelt, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Purdue University

Disqualifiers: Recent pneumonia, Head/neck surgery, Others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 14

Duration: 12 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if a new wearable technology, i-Phagia, can improve swallowing ability, particularly for individuals who have had a stroke or have Parkinson's disease and experience dysphagia. The trial will also compare the effectiveness of telehealth therapy at home with in-person therapy. Individuals diagnosed with a stroke at least three months ago or with Parkinson's disease who have swallowing difficulties may be suitable for this study. Participants will engage in a 12-week program with regular therapy sessions and home exercises, using sEMG-biofeedback, a type of biofeedback therapy. As an unphased trial, this study offers a unique opportunity to explore innovative therapy methods that could enhance quality of life.

Will I have to stop taking my current medications?

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 prior data suggests that this wearable biofeedback device is safe for treating swallowing disorders?

A previous study demonstrated that using surface electromyographic (sEMG) biofeedback improves swallowing exercises by boosting muscle activity during swallowing. This method benefits people with dysphagia, a condition that makes swallowing difficult. The device used in this trial, called i-Phagia, consists of common materials and has been deemed a low-risk device by the Purdue University IRB, indicating it is expected to be safe for humans.

Research also shows that combining sEMG biofeedback with game-based training can greatly enhance swallowing function in stroke patients. This suggests that the treatment is not only safe but also effective in aiding recovery. Overall, the evidence supports the safety and potential benefits of using sEMG biofeedback for swallowing problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of wearable biofeedback for swallowing disorders because it introduces a tech-driven approach with the i-Phagia system. Unlike traditional therapy that relies solely on in-person techniques, this system uses surface electromyography (sEMG) biofeedback to help patients understand and improve their swallowing function. The i-Phagia system can be used both in-person and remotely via telehealth, offering flexibility and potentially increasing accessibility for patients. This innovative method could enhance patient engagement and improve outcomes by providing real-time feedback, making it a promising development in the treatment of swallowing disorders.

What evidence suggests that this biofeedback device is effective for improving swallowing function in patients with dysphagia?

Research has shown that sEMG biofeedback, available to participants in this trial through the i-Phagia system, can aid in improving swallowing. In one study, participants with swallowing problems improved after biofeedback sessions, enabling them to eat normally again. Another study found that this technology enhanced swallowing and quality of life for individuals with Parkinson's disease and swallowing difficulties. The biofeedback provides real-time information about muscle activity, helping individuals learn better swallowing techniques. Overall, early results suggest this method could be effective in enhancing swallowing therapy. ^{2 6 7 8 9}

Who Is on the Research Team?

Georgia Malandraki, PhD

Principal Investigator

Purdue University

Are You a Good Fit for This Trial?

This trial is for individuals with swallowing difficulties after a stroke or those diagnosed with Parkinson's Disease. Participants will undergo a 12-week swallow therapy protocol and must be able to attend three in-person evaluations. They should also commit to exercising at home and maintaining an exercise diary.

Inclusion Criteria

Score in the normal/mild range on the Montreal Cognitive Assessment (MoCA) determined during an in-house screening

I am between 50 and 90 years old.

I was diagnosed with a stroke or Parkinson's disease (stages II-IV) over 3 months ago.

Exclusion Criteria

Known allergies relating to the Ten20® Conductive Paste or sensor materials (gold/acrylic) used in the study

Inability to perform prescribed exercises accurately after a maximum of 12 practice trials as evaluated by the certified and trained SLP during the intervention VFSS assessment

Difficulty complying due to neuropsychological dysfunction determined during the in-house screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete a 12-week swallow treatment protocol using the i-Phagia system, either in-person or via telehealth, with weekly treatment sessions and home exercises.

12 weeks

12 treatment visits (in-person or virtual), 3 in-person evaluations

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluations at 1 week and 12 weeks post-treatment.

12 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• sEMG-biofeedback

Trial Overview The study tests if using wearable biofeedback technology (i-Phagia) alongside standard swallow therapy improves swallowing function better than standard treatment alone, both in-person and via telehealth. It also examines which patient factors affect the success of the treatment.

How Is the Trial Designed?

Group I: Standard-of-Care (SOC) Swallow Treatment Experimental Treatment 1 Intervention

The treatment group assigned to the SOC service delivery will complete the same standardized swallowing rehabilitation protocol and in the same frequency as the i-Phagia groups but without the device. That is, they will complete the protocol for 12 weeks with weekly (once per week) treatment sessions completed in-person and 3 days of home practice per week.

Group II: IN-person i-Phagia Experimental Treatment 1 Intervention

The treatment group assigned to the IN-PERSON i-Phagia service delivery will use the system to complete a standardized swallowing rehabilitation protocol for 12 weeks with weekly (once per week) treatment sessions in the clinic and 3 days of home practice per week.

Group III: Remote i-Phagia Active Control 1 Intervention

The treatment group assigned to the REMOTE i-Phagia service delivery will use the i-Phagia system to complete a standardized swallowing rehabilitation protocol for 12 weeks with weekly (once per week) treatment sessions completed remotely (via telehealth) and 3 days of home practice per week.

Who Is Running the Clinical Trial?

Purdue University

Lead Sponsor

Trials

239

Recruited

72,200+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06638944

Wearable Biofeedback for Swallowing Disorders ... The hypothesis is that upon study completion, the efficacy of sEMG biofeedback-facilitated swallow therapy for both in-person and telehealth service delivery ...

2. reporter.nih.gov reporter.nih.gov/project-details/10858369

Impact of wearable biofeedback for the rehabilitation and ... The aims of this study are to: 1) compare the safety, satisfaction, and efficacy of sEMG biofeedback as adjunct to in-person swallow treatment and a standard- ...

3. leader.pubs.asha.org leader.pubs.asha.org/doi/10.1044/leader.FTR2.09132004.2

Treating Dysphagia With sEMG Biofeedback After nine weeks and 27 sessions of treatment, the client's swallowing had improved and she was able to resume functional oral intake. Note that the biofeedback ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/1460-6984.12824

An intensive neurorehabilitation programme with sEMG ... Biofeedback has positive effects on increasing swallowing function and quality of life in people with IPD and dysphagia. sEMG is the most common ...

5. trialx.com trialx.com/clinical-trials/listings/309450/wearable-biofeedback-for-swallowing-disorders-rehabilitation-in-stroke-and-parkinson-disease/?&radius=50

Wearable Biofeedback for Swallowing Disorders ... The hypothesis is that upon study completion, the efficacy of sEMG biofeedback-facilitated swallow therapy for both in-person and telehealth ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8004490/

Surface Electromyographic Biofeedback and the Effortful ... The ES is a physiologically beneficial dysphagia exercise, increasing muscle activity during swallowing. sEMG biofeedback further enhances performance.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0197457223003038

Efficacy of game training combined with surface ... Game training combined with surface electromyography biofeedback can significantly improve the swallowing function of patients with dysphagia after stroke.

8. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1649961/full

a systematic review and network meta-analysis Surface electromyography biofeedback (sEMG-BF) therapy, a novel rehabilitation technique, has gained increasing attention and demonstrated ...

9. swallowingdisorderfoundation.com swallowingdisorderfoundation.com/swallowing-exercise-with-biofeedback/

Swallowing Exercise with Biofeedback sEMG biofeedback is a nice enhancement to swallowing exercise because it offers a means to engage with your exercises and challenge yourself.