RECRUITING

Wearable Biofeedback for Swallowing Disorders Rehabilitation in Stroke and Parkinson Disease

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-04-15
Study Completion:2029-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06638944

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 50-90 years old
  2. * a confirmed (by a neurologist/physician) diagnosis of stroke at least 3 months post event, or of PD (Hoehn and Yahr Stages II-IV)
  3. * score in the normal/mild range on the Montreal Cognitive Assessment (MoCA), determined during an in-house screening
  4. * confirmed oropharyngeal dysphagia, as evaluated during the intervention eligibility assessment by a certified and trained Speech Language Pathologist (SLP)
  5. * accuracy of exercise performance; as evaluated during the intervention eligibility assessment by a certified and trained SLP
  6. * 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
  1. * known allergy to barium or known/suspected perforation or obstruction of the gastrointestinal (GI) tract
  2. * recent history of pneumonia (past 6 months)
  3. * head and neck surgery, radiation or trauma
  4. * a score in the moderate-severe range on MoCA (screened during in-house screening)
  5. * other neurological/neuromuscular disorders (e.g., multiple sclerosis, brain tumor, myositis, etc)
  6. * difficulty complying due to neuropsychological dysfunction determined during the in-house screening
  7. * currently enrolled in swallow or speech therapy
  8. * facial hair in the submental (under the chin) area and refusing to shave.
  9. * 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
  10. * no oropharyngeal dysphagia; as evaluated during the intervention eligibility assessment by the certified and trained SLP
  11. * 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
  12. * 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
  13. * inability to safely swallow (without aspiration) at least one consistency; as evaluated during the intervention eligibility assessment by the certified and trained SLP

Contacts and Locations

Study Contact

Georgia Malandraki, PhD
CONTACT
765-496-0207
malandraki@purdue.edu
Shelley Reichelt, MS
CONTACT
765-496-0207
sreichel@purdue.edu

Principal Investigator

Georgia Malandraki, PhD
PRINCIPAL_INVESTIGATOR
Purdue University

Study Locations (Sites)

Purdue University
West Lafayette, Indiana, 47907
United States

Collaborators and Investigators

Sponsor: Purdue University

  • Georgia Malandraki, PhD, PRINCIPAL_INVESTIGATOR, Purdue University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-15
Study Completion Date2029-04-30

Study Record Updates

Study Start Date2025-04-15
Study Completion Date2029-04-30

Terms related to this study

Keywords Provided by Researchers

  • biofeedback
  • dysphagia
  • oropharyngeal dysphagia
  • Parkinson disease
  • stroke
  • telehealth
  • wearable

Additional Relevant MeSH Terms

  • Dysphagia
  • Stroke
  • Parkinson Disease