Actively Recruiting

Phase 2
Age: 50Years - 90Years
All Genders
NCT06638944

Wearable Biofeedback for Swallowing Disorders Rehabilitation in Stroke and Parkinson Disease

Led by Purdue University · Updated on 2026-01-12

120

Participants Needed

1

Research Sites

196 weeks

Total Duration

On this page

Sponsors

P

Purdue University

Lead Sponsor

N

National Institute on Aging (NIA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Wearable Biofeedback for Swallowing Disorders Rehabilitation in Stroke and Parkinson Disease

Who Can Participate

Age: 50Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 50 and 90 years
  • Confirmed diagnosis of stroke at least 3 months prior or Parkinson's disease at Hoehn and Yahr Stages II-IV
  • Normal or mild cognitive function based on the Montreal Cognitive Assessment (MoCA)
  • Confirmed oropharyngeal dysphagia as evaluated by a certified Speech Language Pathologist (SLP)
  • Ability to perform swallowing exercises accurately as evaluated by a certified SLP
  • Ability to independently or with caregiver support use the i-Phagia system after training as evaluated by a certified SLP
Not Eligible

You will not qualify if you...

  • Allergy to barium or suspected gastrointestinal tract perforation or obstruction
  • History of pneumonia within the past 6 months
  • Previous head and neck surgery, radiation, or trauma
  • Moderate to severe cognitive impairment based on MoCA
  • Other neurological or neuromuscular disorders (e.g., multiple sclerosis, brain tumor, myositis)
  • Difficulty complying due to neuropsychological dysfunction
  • Current enrollment in swallow or speech therapy
  • Facial hair under the chin area if refusing to shave
  • Allergy to Ten20�ae Conductive Paste or any sensor materials contacting the skin
  • No oropharyngeal dysphagia as evaluated by a certified SLP
  • Inability to perform prescribed exercises accurately after up to 12 practice trials
  • Inability to use the i-Phagia system accurately after training
  • Inability to safely swallow at least one consistency without aspiration as evaluated by a certified SLP

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Purdue University

West Lafayette, Indiana, United States, 47907

Actively Recruiting

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Research Team

G

Georgia Malandraki, PhD

CONTACT

S

Shelley Reichelt, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Wearable Biofeedback for Swallowing Disorders Rehabilitation in Stroke and Parkinson Disease | DecenTrialz