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Wearable Biofeedback for Swallowing Disorders Rehabilitation in Stroke and Parkinson Disease

Impact of Wearable Biofeedback for the Rehabilitation and Tele-rehabilitation of Neurogenic Dysphagia

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years to 90 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether adding i-Phagia, a wearable sensor that gives feedback on muscle activity, to swallowing therapy improves swallowing. It is for adults ages 50–90 who have trouble swallowing after a stroke or with Parkinson’s disease. The study also compares therapy at home by video visits with therapy in a clinic.

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 with post-acute phase 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 with post-acute phase 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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 50–90 years old.
  • A doctor confirmed a stroke at least 3 months ago or Parkinson’s disease at stages II–IV on the Hoehn and Yahr scale.
  • Your thinking and memory test shows normal ability or mild problems.
  • A trained speech therapist confirms trouble swallowing in your mouth or throat.
  • A trained speech therapist confirms that you can do the exercises correctly.
  • After training, you can use i-Phagia on your own or with help from a caregiver.

Who can't join

  • You are allergic to barium, the sensor paste, or sensor materials that touch your skin, including gold or acrylic.
  • You have a known or suspected hole or blockage in your digestive tract, or had pneumonia in the past 6 months.
  • You have had head or neck surgery, radiation treatment, or injury.
  • You have moderate to severe thinking or memory problems, problems with brain function that make it hard to follow study steps, or another brain, nerve, or muscle disorder.
  • You are currently getting swallowing or speech therapy, or have hair under your chin and will not shave it.
  • A speech therapist finds that you do not have trouble swallowing in your mouth or throat.
  • You cannot do the exercises correctly after up to 12 practice tries, or cannot use i-Phagia correctly after training if assigned to use it.
  • You cannot safely swallow any tested food or liquid thickness without it entering your airway.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 50-90 years old * a confirmed (by a neurologist/physician) diagnosis of stroke and completion of acute inpatient medical care, as documented by discharge from the acute care setting, or of PD (Hoehn and Yahr Stages II-IV) * 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 * 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

Study sites (2)

IL

IN