Wearable biofeedback device for improving swallowing in stroke and Parkinson's patients
Impact of Wearable Biofeedback for the Rehabilitation and Tele-rehabilitation of Neurogenic Dysphagia
This study tests a new wearable device that helps stroke and Parkinson's patients improve their swallowing by giving them real-time feedback during therapy sessions.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 50 Years to 90 Years |
| Sex | All |
| Sponsor | Purdue University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (West Lafayette, Indiana) |
| Trial ID | NCT06638944 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50-90 with a confirmed diagnosis of stroke or Parkinson's disease and experiencing oropharyngeal dysphagia.
Not a fit: Patients with recent pneumonia, gastrointestinal tract issues, or significant cognitive impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance swallowing function and quality of life for patients with dysphagia due to neurological conditions.
How similar studies have performed: While the use of biofeedback in dysphagia treatment is emerging, this specific approach with the i-Phagia device is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
West Lafayette, Indiana
- Purdue University — West Lafayette, Indiana, United States (Recruiting)
Study contacts
- Principal investigator: Georgia Malandraki, PhD — Purdue University
- Study coordinator: Georgia Malandraki, PhD
- Email: malandraki@purdue.edu
- Phone: 765-496-0207
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.