Recruiting · registry statusUsing a wearable device to support swallowing practice
Researchers are studying a wearable feedback device for swallowing rehabilitation in people with Parkinson’s or stroke.
Testing a treatment or activity · Study reference: NCT06638944
Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓
Open the official registry record ↗Who can join?
Ages 50 years to 90 years · Does not accept healthy volunteers
These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.
Read all the rules for taking part
Sex eligibility reported by registry: all
Inclusion Criteria:
* 50-90 years old
* a confirmed (by a neurologist/physician) diagnosis of stroke at least 3 months post event, or of PD (Hoehn and Yahr Stages II-IV)
* score in the normal/mild range on the Montreal Cognitive Assessment (MoCA), determined during an in-house screening
* 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
* a score in the moderate-severe range on MoCA (screened during in-house screening)
* 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
Full study name & original research details
Official study title
Impact of Wearable Biofeedback for the Rehabilitation and Tele-rehabilitation of Neurogenic Dysphagia
Short title used by the registry
Wearable Biofeedback for Swallowing Disorders Rehabilitation in Stroke and Parkinson Disease
Original 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.
Conditions reported: Dysphagia; Stroke; Parkinson Disease
- Study type
- Interventional
- Interventions
- In-person sEMG-biofeedback; Remote sEMG-biofeedback; Standard-of-care treatment
- Phases
- PHASE2
- Sponsor
- University of Illinois at Urbana-Champaign
- Start date reported by registry
- 2025-07-22 (actual)
Registry updated: 2026-09-11 · Status last verified by the registry submitter: 2026-09
Registry records retrieved 2026-10-11 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.
Contact the research team
Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.
Georgia Malandraki, PhD · 217-265-7561 · georgiam@illinois.edu
Jaime Bauer Malandraki, MS · 217-265-7561 · jaimebm@illinois.edu
Study locations
Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.
University of Illinois Urbana-Champaign
Champaign, Illinois, United States
RecruitingGeorgia Malandraki, PhD · 217-265-7561 · georgiam@illinois.edu
Jaime Bauer Malandraki, MS · 217-265-7561 · jaimebm@illinois.edu
Georgia Malandraki, PhD
Purdue University
West Lafayette, Indiana, United States
RecruitingShelley Reichelt, MS · 765-496-0207 · sreichel@purdue.edu
The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.