DysphagiaPhase 2NCT06638944
Wearable Biofeedback for Swallowing Disorders Rehabilitation in Stroke and Parkinson Disease
A Phase 2 study testing In-person sEMG-biofeedback, Remote sEMG-biofeedback and Standard-of-care treatment in people with Dysphagia and Stroke, run by University of Illinois at Urbana-Champaign at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Dysphagia, Stroke, Parkinson Disease
- What is being tested?
- In-person sEMG-biofeedback, Remote sEMG-biofeedback and Standard-of-care treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Jul 2025to 30 Apr 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Illinois Urbana-Champaign
Champaign, Illinois, 61820
Georgia Malandraki, PhD, 217-265-7561, georgiam@illinois.edu
Jaime Bauer Malandraki, MS, 217-265-7561, jaimebm@illinois.edu
- Recruiting
Purdue University
West Lafayette, Indiana, 47907
Shelley Reichelt, MS, 765-496-0207, sreichel@purdue.edu
About this study
Official title: Impact of Wearable Biofeedback for the Rehabilitation and Tele-rehabilitation of Neurogenic Dysphagia
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.
Read more
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.
- Conditions
- Dysphagia, Stroke, Parkinson Disease
- Being tested
- In-person sEMG-biofeedback, Remote sEMG-biofeedback, Standard-of-care treatment
- Keywords
- biofeedback, dysphagia, oropharyngeal dysphagia, Parkinson disease, stroke, telehealth, wearable
- Medical subject headings
- Deglutition Disorders, Stroke, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-person sEMG-biofeedbackBehavioural
Participants in this intervention complete a standardized behavioral swallowing rehabilitation protocol for 12 weeks with weekly (once per week) treatment sessions in the clinic and 3 days of home practice per week using the i-Phagia sEMG system. The protocol includes oropharyngeal strength training and skill-based practice exercises. For this group, patients use the sensor patch and the software guides them on how to complete the exercises and receive feedback.
Remote sEMG-biofeedbackBehavioural
Participants in this intervention complete a standardized behavioral swallowing rehabilitation protocol for 12 weeks with weekly (once per week) treatment sessions completed remotely (via telehealth) and 3 days of home practice per week. The protocol includes oropharyngeal strength training and skill-based practice exercises. For this group, patients also use the sensor patch and the software guides them on how to complete the exercises and receive feedback.
Standard-of-care treatmentBehavioural
Participants in this intervention will complete the same standardized behavioral swallowing rehabilitation protocol and in the same frequency as the sEMG biofeedback intervention groups but WITHOUT a device. That is, they will complete the protocol for 12 weeks with weekly (once per week) treatment sessions completed in-person and 3 days of home practice per week. For this intervention group, patients use a visual analog scale and a timer as feedback tools, as frequently done in clinical practice where sEMG devices are not widely available.
| Study group | Role | What they receive |
|---|---|---|
| IN-person i-Phagia | Experimental | The treatment group assigned to the IN-PERSON i-Phagia service delivery will use the system to complete a standardized swallowing rehabilitation protocol for 12 weeks with weekly (once per week) treatment sessions in the clinic and 3 days of home practice per week. Receives: Behavioral: In-person sEMG-biofeedback |
| Remote i-Phagia | Active comparator | The treatment group assigned to the REMOTE i-Phagia service delivery will use the i-Phagia system to complete a standardized swallowing rehabilitation protocol for 12 weeks with weekly (once per week) treatment sessions completed remotely (via telehealth) and 3 days of home practice per week. Receives: Behavioral: Remote sEMG-biofeedback |
| Standard-of-Care (SOC) Swallow Treatment | Other | The treatment group assigned to the SOC service delivery will complete the same standardized swallowing rehabilitation protocol and in the same frequency as the i-Phagia groups but without the device. That is, they will complete the protocol for 12 weeks with weekly (once per week) treatment sessions completed in-person and 3 days of home practice per week. Receives: Behavioral: Standard-of-care treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Penetration-Aspiration Scale (PAS)
The Penetration Aspiration Scale (PAS) is an 8-point scale, where 1 indicates a completely safe swallow without any penetration or aspiration present, and 8 indicates the most severe degree of aspiration with no attempt to clear the aspirated material. The PAS will be rated by trained investigators blinded to group/arm and time.
Measured: Pre-treatment; up to 1 week post-treatment; and at a 12-week follow-up
Functional Oral Intake Scale (FOIS)
The Functional Oral Intake Scale (FOIS) is a 7-point ordinal scale (1 indicating nothing by mouth-NPO; and 7 indicating eating without restrictions). It will be rated by the evaluating speech-language pathologist/investigator based on patient report of current diet, to assess functional ability for oral intake.
Measured: Pre-treatment; up to 1 week post-treatment; and at a 12-week follow-up
Normalized sEMG amplitude
Normalized surface electromyography (sEMG) amplitude values during standardized swallow tasks and maneuvers will be collected at the evaluation time points. The sEMG data will be analyzed by blinded to group/arm and time investigators using a custom-made EMG analysis Matlab script.
Measured: Pre-treatment; up to 1 week post-treatment; and at a 12-week follow-up
Secondary outcomes (3)
Swallowing-related Quality of Life (SWAL-QOL)
The SWAL-QOL is a 44-item tool/survey consisting of 10 multi-item scales (food selection, burden, mental health, social functioning, fear, eating duration, eating desire, communication, sleep, and fatigue) ranging in score from 0-100. Higher scores indicate better quality of life.
Measured: Pre-treatment; up to 1 week post-treatment; and at a 12-week follow-up
Patient Satisfaction
Satisfaction and ease-of-use/comfort with the modality (in-person; remote), and materials used (e.g., i-Phagia), will be examined as a secondary variable using a 10-item survey with a positive centered 10-point Likert scale. Possible scores 0-100. Higher values indicate better or higher satisfaction/comfort scores.
Measured: From date of treatment initiation until the date of the post-treatment evaluation, assessed up to 13 weeks
Treatment adherence
Treatment adherence will be calculated as a percent - number of treatment days when all exercises are completed over the total number of treatment days.
Measured: From date of treatment initiation until the date of the post-treatment evaluation, assessed up to 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start22 Jul 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Purdue University
- Responsible party
- Principal investigator, Georgia Malandraki, University of Illinois at Urbana-Champaign
- Investigators
- Georgia Malandraki, PhD, Principal investigator, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06638944
- Sponsor's protocol ID
- IRB-2024-2
- Other IDs
- 1R01AG086371-01
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the NIH approved data management and sharing plan, all de-identified demographic, clinical (cognitive, psychological), VFSS, quality of life, satisfaction, safety, treatment adherence and stimulability, and electromyographic data will be shared. All data will be shared in their raw pre-processed format. Respondent identifiers will not be shared. All data will be deidentified prior to receipt by the repository. In addition to the subject level data described above, the VFSS and EMG protocol designs and the treatment protocol will be shared as well, to facilitate replication. This project will use the Purdue University Research Repository (PURR) to publicly share, archive, and preserve the data. PURR utilizes a web-mediated software platform designed for archiving and sharing of scientific data and meets the standards for ISO 16363 Trusted Digital Repositories. Through PURR, investigators that wish to access the data do not need to be affiliated with Purdue University.