Wearable Biofeedback for Swallowing Disorders Rehabilitation in Stroke and Parkinson Disease
{ "Wearable Biofeedback for Swallowing Disorders in Stroke and Parkinson Disease", "This study is testing new ways to help people with swallowing difficulties (dysphagia) caused by stroke or Parkinson's disease. Researchers are comparing a wearable device called i-Phagia, which uses surface electromyography (sEMG) biofeedback to help you practice swallowing, against standard care. You would either use the i-Phagia device in person at a clinic, use it remotely from home with telehealth, or receive standard swallowing therapy without the device. The study aims to see if these methods improve your swallowing ability and how well you can eat by mouth. To join, you need to be between 50 and 90 years old, have a confirmed diagnosis of stroke (at least 3 months ago) or Parkinson's disease, and have confirmed swallowing difficulties.", "design": "This interventional study plans to enroll 120 participants. It compares three different approaches to swallowing rehabilitation.", "commitments": "Participants will complete a standardized swallowing rehabilitation program for 12 weeks. This includes weekly treatment sessions and 3 days of home practice per week.", "compensation": "Not stated in the trial record.", "follow_up": "Your swallowing ability will be checked before treatment, up to one week after treatment, and again 12 weeks after treatment.", }
- Study design
- Not specified.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Not specified.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Wearable Biofeedback for Swallowing Disorders Rehabilitation in Stroke and Parkinson Disease
At a glance
Conditions
NCT06638944
Where you'd take part
This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Purdue University
West Lafayette, Indianastudy coordinator listed
Recruiting
University of Illinois Urbana-Champaign
Champaign, Illinoisstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Georgia Malandraki, PhD · PRINCIPAL_INVESTIGATOR · University of Illinois at Urbana-Champaign
Who to contact
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Inclusion
Exclusion
What this trial measures
- Penetration-Aspiration Scale (PAS)Pre-treatment; up to 1 week post-treatment; and at a 12-week follow-up
The Penetration Aspiration Scale (PAS) is an 8-point scale, where 1 indicates a completely safe swallow without any penetration or aspiration present, and 8 indicates the most severe degree of aspiration with no attempt to clear the aspirated material. The PAS will be rated by trained investigators blinded to group/arm and time.
- Functional Oral Intake Scale (FOIS)Pre-treatment; up to 1 week post-treatment; and at a 12-week follow-up
The Functional Oral Intake Scale (FOIS) is a 7-point ordinal scale (1 indicating nothing by mouth-NPO; and 7 indicating eating without restrictions). It will be rated by the evaluating speech-language pathologist/investigator based on patient report of current diet, to assess functional ability for oral intake.
- Normalized sEMG amplitudePre-treatment; up to 1 week post-treatment; and at a 12-week follow-up
Normalized surface electromyography (sEMG) amplitude values during standardized swallow tasks and maneuvers will be collected at the evaluation time points. The sEMG data will be analyzed by blinded to group/arm and time investigators using a custom-made EMG analysis Matlab script.