Wearable Biofeedback for Swallowing Disorders Rehabilitation in Stroke and Parkinson Disease

Launched by PURDUE UNIVERSITY · Oct 10, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new device called i-Phagia, which is a wearable technology that helps people with swallowing difficulties, known as dysphagia. This condition is common in individuals who have had a stroke or have Parkinson’s disease. The main goal of the trial is to see if using this device along with standard swallow therapy improves swallowing function better than just the standard treatment alone. The researchers also want to find out if doing this therapy at home through telehealth is as effective as going to a clinic for in-person sessions.

To participate in the trial, individuals need to be between 50 and 90 years old and have a confirmed diagnosis of stroke or Parkinson’s disease. They should also be experiencing difficulty swallowing and be able to complete the required exercises at home. Participants will follow a 12-week treatment plan, attending sessions either in person or via telehealth, and will be asked to keep track of their exercises in a diary. Throughout the trial, they will undergo evaluations to measure their progress. This study aims to learn more about how well the new technology works and what factors might affect its success.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 50-90 years old
• • a confirmed (by a neurologist/physician) diagnosis of stroke at least 3 months post event, 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 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
• • 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 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