Clinical trial NCT06638944: Wearable Biofeedback for Swallowing Disorders Rehabilitation in Stroke and Parkinson Disease
Official title: Impact of Wearable Biofeedback for the Rehabilitation and Tele-rehabilitation of Neurogenic Dysphagia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dysphagia
Stroke
Parkinson Disease
Keywords: biofeedback
dysphagia
oropharyngeal dysphagia
Parkinson disease
stroke
telehealth
wearable
Lead sponsor: Purdue University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2024-10-15
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Penetration-Aspiration Scale (PAS)
timeFrame: Pre-treatment; up to 1 week post-treatment; and at a 12-week follow-up
measure: Functional Oral Intake Scale (FOIS)
timeFrame: Pre-treatment; up to 1 week post-treatment; and at a 12-week follow-up
measure: Normalized sEMG amplitude
timeFrame: Pre-treatment; up to 1 week post-treatment; and at a 12-week follow-up
Secondary outcomes:
measure: Swallowing-related Quality of Life (SWAL-QOL)
timeFrame: Pre-treatment; up to 1 week post-treatment; and at a 12-week follow-up
measure: Patient Satisfaction
timeFrame: From date of treatment initiation until the date of the post-treatment evaluation, assessed up to 13 weeks
measure: Treatment adherence
timeFrame: From date of treatment initiation until the date of the post-treatment evaluation, assessed up to 13 weeks
Other outcomes:
measure: Stimulability
timeFrame: Pre-treatment
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
affiliation: Purdue University
name: Georgia Malandraki, PhD
role: PRINCIPAL_INVESTIGATOR
References: