Wearable Biofeedback for Swallowing Disorders Rehabilitation in Stroke and Parkinson Disease

Summary

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.

Conditions

• Dysphagia
• Stroke
• Parkinson Disease

Interventions

BEHAVIORAL

In-person sEMG-biofeedback

Participants in this intervention complete a standardized behavioral swallowing rehabilitation protocol for 12 weeks with weekly (once per week) treatment sessions in the clinic and 3 days of home practice per week using the i-Phagia sEMG system. The protocol includes oropharyngeal strength training and skill-based practice exercises. For this group, patients use the sensor patch and the software guides them on how to complete the exercises and receive feedback.

BEHAVIORAL

Remote sEMG-biofeedback

Participants in this intervention complete a standardized behavioral 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. The protocol includes oropharyngeal strength training and skill-based practice exercises. For this group, patients also use the sensor patch and the software guides them on how to complete the exercises and receive feedback.

BEHAVIORAL

Standard-of-care treatment

Participants in this intervention will complete the same standardized behavioral swallowing rehabilitation protocol and in the same frequency as the sEMG biofeedback intervention groups but WITHOUT a 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. For this intervention group, patients use a visual analog scale and a timer as feedback tools, as frequently done in clinical practice where sEMG devices are not widely available.

Sponsors & Collaborators

• National Institute on Aging (NIA)

  collaborator NIH

• Purdue University

  lead OTHER

Principal Investigators

• Georgia Malandraki, PhD · Purdue University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-22

Primary Completion

2028-12-31

Completion

2029-04-30

Countries

• United States

Study Locations