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Wearable Biofeedback for Swallowing Disorders Rehabilitation in Stroke and Parkinson Disease

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Minor Site details revised at 1 of 2 sitesv10
  2. Notable Sponsor changed: Purdue University to University of Illinois at Urbana-Champaign
    • Site contacts updated at 2 of 2 sites
    • Collaborators: 1 to 2
    v9
  3. Minor Study sites: 1 to 2v8
  4. Notable Phase: Not applicable to Phase 2v7
  5. Minor Start date changed from estimate of Jul 21, 2025 to Jul 22, 2025v6
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  1. Notable Start date: May 2025 to Jul 21, 2025v5
  2. Minor Start date: Apr 15, 2025 to May 2025v4
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v3
  4. Notable Start date: Jan 1, 2025 to Apr 15, 2025
    • Primary completion date: Oct 15, 2028 to Dec 31, 2028
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06638944
Lead Sponsor University of Illinois at Urbana-Champaign
Collaborators: National Institute on Aging (NIA), Purdue University
Conditions
(from sponsor)
Dysphagia, Stroke, Parkinson Disease
Related terms Deglutition Disorders, Parkinson Disease, Stroke
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov