NCT06638944RecruitingPhase 2
Wearable Biofeedback for Swallowing Disorders Rehabilitation in Stroke and Parkinson Disease
Impact of Wearable Biofeedback for the Rehabilitation and Tele-rehabilitation of Neurogenic Dysphagia
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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 with post-acute phase 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 with post-acute phase 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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 7 Oct 2024
- Start date
- 22 Jul 2025
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Diseases
- Stroke, Parkinson disease
- NCT number
- NCT06638944
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 120
- From 22 Jul 2025 to the primary completion date, 31 Dec 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- head and neck surgery, radiation or trauma
- currently enrolled in swallow or speech therapy
Other illness
- known allergy to barium or known/suspected perforation or obstruction of the gastrointestinal (GI) tract
- recent history of pneumonia (past 6 months)
- other neurological/neuromuscular disorders (e.g., multiple sclerosis, brain tumor, myositis, etc)
- 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
Other
- difficulty complying due to neuropsychological dysfunction determined during the in-house screening
- facial hair in the submental (under the chin) area and refusing to shave.
- 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
Who the study is looking for
- 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
Age in the registry: 50 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Illinois Urbana-Champaign Coordinator of this site? Confirm its status | Champaign | United States | Recruiting |
| Purdue University Coordinator of this site? Confirm its status | West Lafayette | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.