Wearable biofeedback device for improving swallowing in stroke and Parkinson's patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of a novel wearable biofeedback device, i-Phagia, designed to assist patients with swallowing disorders resulting from stroke or Parkinson's disease. The device utilizes surface electromyography (sEMG) to monitor muscle activity in the head and neck, providing real-time feedback to patients during swallow therapy. Participants will receive both in-person and remote biofeedback sessions, alongside standard care, to evaluate improvements in swallowing function. The study aims to validate this technology as a cost-effective adjunct to traditional therapy protocols.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 50-90 years old
* a confirmed (by a neurologist/physician) diagnosis of stroke and completion of acute inpatient medical care, as documented by discharge from the acute care setting, or of PD (Hoehn and Yahr Stages II-IV)
* confirmed oropharyngeal dysphagia, as evaluated during the intervention eligibility assessment by a certified and trained Speech Language Pathologist (SLP)
* accuracy of exercise performance; as evaluated during the intervention eligibility assessment by a certified and trained SLP
* independent (or with caregiver support) use of i-Phagia system post pre-intervention training session; as evaluated during the intervention eligibility assessment by a certified and trained SLP

Exclusion Criteria:

* known allergy to barium or known/suspected perforation or obstruction of the gastrointestinal (GI) tract
* recent history of pneumonia (past 6 months)
* head and neck surgery, radiation or trauma
* other neurological/neuromuscular disorders (e.g., multiple sclerosis, brain tumor, myositis, etc)
* difficulty complying due to neuropsychological dysfunction determined during the in-house screening
* currently enrolled in swallow or speech therapy
* facial hair in the submental (under the chin) area and refusing to shave.
* known allergies relating to the Ten20® Conductive Paste (this is the conductive paste used to help with sensors signal and adherence to the skin) and/or any of the sensor materials (gold/acrylic) that come into contact with the skin
* no oropharyngeal dysphagia; as evaluated during the intervention eligibility assessment by the certified and trained SLP
* inability to perform the prescribed exercises accurately after a maximum of 12 practice trials; as evaluated during the intervention eligibility VFSS assessment by the certified and trained SLP
* inability to use the system accurately post training (for i-Phagia groups); as evaluated during the intervention eligibility assessment by the certified and trained SLP
* inability to safely swallow (without aspiration) at least one consistency; as evaluated during the intervention eligibility assessment by the certified and trained SLP

Where it's running

• University of Illinois Urbana-Champaign
  Champaign, Illinois, United States Recruiting
• Purdue University
  West Lafayette, Indiana, United States Recruiting

Study contacts

• Principal investigator: Georgia Malandraki, PhD — University of Illinois at Urbana-Champaign
• Study coordinator: Georgia Malandraki, PhD
• Email: georgiam@illinois.edu
• Phone: 217-265-7561

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.