💬In plain words
What the trial is, and whether it could suit you
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 diagno
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
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