Wearable Biofeedback for Swallowing Disorders Rehabilitation in Stroke and Parkinson Disease

Last updated: April 10, 2025
Sponsor: Purdue University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Heartburn

Treatment

Remote sEMG-biofeedback

In-person sEMG-biofeedback

Standard-of-care treatment

Clinical Study ID

NCT06638944
IRB-2024-2
1R01AG086371-01
  • Ages 50-90
  • All Genders

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 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 50-90 years old

  • a confirmed (by a neurologist/physician) diagnosis of stroke at least 3 months postevent, 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 eligibilityassessment by a certified and trained Speech Language Pathologist (SLP)

  • accuracy of exercise performance; as evaluated during the intervention eligibilityassessment by a certified and trained SLP

  • independent (or with caregiver support) use of i-Phagia system post pre-interventiontraining session; as evaluated during the intervention eligibility assessment by acertified and trained SLP

Exclusion

Exclusion Criteria:

  • known allergy to barium or known/suspected perforation or obstruction of thegastrointestinal (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 thein-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 conductivepaste used to help with sensors signal and adherence to the skin) and/or any of thesensor materials (gold/acrylic) that come into contact with the skin

  • no oropharyngeal dysphagia; as evaluated during the intervention eligibilityassessment by the certified and trained SLP

  • inability to perform the prescribed exercises accurately after a maximum of 12practice trials; as evaluated during the intervention eligibility VFSS assessment bythe certified and trained SLP

  • inability to use the system accurately post training (for i-Phagia groups); asevaluated during the intervention eligibility assessment by the certified andtrained SLP

  • inability to safely swallow (without aspiration) at least one consistency; asevaluated during the intervention eligibility assessment by the certified andtrained SLP

Study Design

Total Participants: 120
Treatment Group(s): 3
Primary Treatment: Remote sEMG-biofeedback
Phase:
Study Start date:
May 01, 2025
Estimated Completion Date:
April 30, 2029

Connect with a study center

  • Purdue University

    West Lafayette, Indiana 47907
    United States

    Active - Recruiting

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