A Phase 2 interventional study of In-person sEMG-biofeedback and Remote sEMG-biofeedback in Dysphagia, Stroke and Parkinson Disease, sponsored by University of Illinois at Urbana-Champaign. Recruiting at 2 sites in United States. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by University of Illinois at Urbana-Champaign · Phase 2, Interventional, and Treatment
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 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:
Participants will:
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.
871 studies on the registry are indexed under Deglutition Disorders; 237 are open to participants now.
This study's planned enrollment of 120 is above the median of 60 across 578 interventional studies indexed under Deglutition Disorders.
Browse Deglutition Disorders studies →University of Illinois at Urbana-Champaign is the lead sponsor of 191 studies on the registry; 29 are open to participants now.
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The criteria were revised on the registry on Oct 16, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Behavioral: In-person sEMG-biofeedback
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.
Behavioral: Remote sEMG-biofeedback
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.
Behavioral: Standard-of-care treatment
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.
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: Pre-treatment; up to 1 week post-treatment; and at a 12-week follow-up
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.
Time frame: 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.
Time frame: 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.
Time frame: From date of treatment initiation until the date of the post-treatment evaluation, assessed up to 13 weeks
Stimulability
Stimulability is operationally defined as the ability to accurately perform the swallowing maneuvers/exercises immediately or quickly when provided with cues or a model. The number of practice trials required to reach accuracy before treatment is initiated will be recorded, and this number will be used for post-hoc analyses on factors influencing treatment response.
Time frame: Pre-treatment
Plan to share: 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.
Supporting information: Study protocol
Time frame: The data will be published, archived, and freely available to the public at the time of an associated publication or the end of the performance period, whichever comes first. The repository will provide bit-level preservation activities, representation information, and sustained monitoring by repository managers for a period of at least ten years and longer as needed or when required by policy.
Access criteria: A. Factors affecting subsequent access, distribution, or reuse of scientific data: In order to ensure participant consent for data sharing, IRB paperwork and informed consent documents will include language describing plans for data management and sharing data, describing the motivation for sharing, and explaining that personal identifying information will be removed. B. Whether access to scientific data will be controlled: Access to data will be freely available, however researchers will be asked to cite the data source in their publications. C. Protections for privacy, rights, and confidentiality of human research participants: Data will be fully de-identified before being uploaded to PURR. No identifying data will be made available at any time.
No publications or documents are linked to this record.
Started Jul 2025 (actual). Primary completion is estimated for Dec 2028, 41 months after the start.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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