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Wearable Biofeedback for Swallowing Disorders Rehabilitation in Stroke and Parkinson Disease
NCT06638944 · View on ClinicalTrials.gov ↗
Study Summary
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 we
Conditions Studied
Interventions
- BEHAVIORAL In-person sEMG-biofeedback
- BEHAVIORAL Remote sEMG-biofeedback
- BEHAVIORAL Standard-of-care treatment
Study Locations (1)
Indiana
- Purdue University — West Lafayette
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2025-07-22 |
| Est. Completion | 2029-04-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06638944
The ClinicalTrials.gov registry entry for NCT06638944 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Purdue University, which has 100 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Stroke appearing as the primary indexed condition, and to 3 interventions — of which In-person sEMG-biofeedback is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06638944 reports 1 study location spanning 1 distinct geographic area — top geographies include Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06638944 about?
NCT06638944 is a clinical study titled "Wearable Biofeedback for Swallowing Disorders Rehabilitation in Stroke and Parkinson Disease". 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 t...
What is the current status of trial NCT06638944?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2025-07-22. Estimated completion is 2029-04-30.
What conditions does trial NCT06638944 study?
This clinical trial studies the following conditions: Stroke, Parkinson Disease, Dysphagia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06638944?
The interventions under investigation include: In-person sEMG-biofeedback (BEHAVIORAL), Remote sEMG-biofeedback (BEHAVIORAL), Standard-of-care treatment (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06638944?
This trial is sponsored by Purdue University, which has 100 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06638944 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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