Wearable Biofeedback for Swallowing Disorders

Recruiting in Palo Alto (17 mi)

Overseen byGeorgia Malandraki, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Purdue University

Stay on Your Current Meds

No Placebo Group

Trial Summary

What is the purpose of this trial?

Dysphagia, or difficulty swallowing, is a common symptom of many neurological diseases but its treatment is not well established or easily accessible. To start addressing this gap, the researchers developed and validated a cost-effective wearable surface electromyography (sEMG) biofeedback sensor technology (i-Phagia), optimized to record muscle activity from the head/neck and provide biofeedback to patients and adherence data to clinicians during swallow therapy. This system has been developed with commercially available and widely used materials and the Purdue University IRB has determined that the device is non-significant risk device. The goal of this clinical trial is to learn if this biofeedback (using this new technology/i-Phagia) when used as an adjunct to a standard swallow therapy protocol works to improve swallowing function in patients post chronic stroke or diagnosed with Parkinson's disease. It will also help the investigators learn whether this therapy protocol is equally effective when provided in-person versus via telehealth. Finally, it will determine which patient factors may influence how well the treatment works. The main questions it aims to answer are: * Does biofeedback (using this new technology/i-Phagia) when used as an adjunct to a standard swallow therapy protocol works better than a standard of care treatment to improve swallowing function in patients post chronic stroke or diagnosed with Parkinson's disease? * Is completing the swallow therapy protocol at home (via telehealth) as effective as completing it in-person (in the clinic)? * What factors related to the patients (e.g., age, diagnosis, etc.) may influence how well the treatment works? Participants will: * Complete a 12-week swallow treatment protocol (12 treatment visits) either in-person or at home (via telehealth) * Complete 3 in-person evaluations (pre-treatment; post-treatment; and at a 12-week post treatment follow-up time point) * Exercise at home several days per week and keep a diary/log of their home exercise The hypothesis is that upon study completion, the efficacy of sEMG biofeedback-facilitated swallow therapy for both in-person and telehealth service delivery in two neurogenic dysphagia populations will have been established, and variables determining response to treatment will begin to be identified.

Eligibility Criteria

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.

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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

I have had pneumonia in the last 6 months.

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Treatment Details

Interventions

sEMG-biofeedback (Behavioral Intervention)

Trial OverviewThe 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.

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Group I: Standard-of-Care (SOC) Swallow TreatmentExperimental Treatment1 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-PhagiaExperimental Treatment1 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-PhagiaActive Control1 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.