NCT06638944

Wearable Biofeedback for Swallowing Disorders Rehabilitation in Stroke and Parkinson Disease

Recruiting now Phase 2 Last updated 12 January 2026

What this trial tests

Phase 2 trial testing In-person sEMG-biofeedback in Dysphagia in 120 participants. Currently enrolling.

Timeline

22 July 2025

Primary endpoint
31 December 2028

30 April 2029

Quick facts

Lead sponsor	Purdue University
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	120
Start date	22 July 2025
Primary completion	31 December 2028
Estimated completion	30 April 2029
Sites	1 location across United States

Drugs / interventions tested

• In-person sEMG-biofeedback
• Remote sEMG-biofeedback
• Standard-of-care treatment

Conditions studied

• Dysphagia — all drugs for Dysphagia →
• Stroke — all drugs for Stroke →
• Parkinson Disease — all drugs for Parkinson Disease →

Sponsor

Purdue University

Who can join

Adults 50 to 90, any sex, with Dysphagia or Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.