Wearable Biofeedback for Swallowing Disorders Rehabilitation in Stroke and Parkinson Disease

NCT06638944 | Recruiting Phase 2 DMC

• 2 other identifiers: IRB-2024-21R01AG086371-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysphagia; Stroke; Parkinson Disease

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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)

  Pre-treatment; up to 1 week post-treatment; and at a 12-week follow-up

• Patient Satisfaction

  From date of treatment initiation until the date of the post-treatment evaluation, assessed up to 13 weeks

• Treatment adherence

  From date of treatment initiation until the date of the post-treatment evaluation, assessed up to 13 weeks

Other Outcomes (1)

• Stimulability

  Pre-treatment

Study Arms (3)

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.

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.

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.

Behavioral: Standard-of-care treatment

Interventions

In-person sEMG-biofeedback BEHAVIORAL

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.

IN-person i-Phagia

Remote sEMG-biofeedback BEHAVIORAL

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.

Remote i-Phagia

Standard-of-care treatment BEHAVIORAL

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.

Standard-of-Care (SOC) Swallow Treatment

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Purdue University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders; Stroke; Parkinson Disease

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Georgia Malandraki, PhD

  Purdue University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Georgia Malandraki, PhD

CONTACT

765-496-0207; malandraki@purdue.edu

Shelley Reichelt, MS

CONTACT

765-496-0207; sreichel@purdue.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 15, 2024
• Study Start: July 22, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): April 30, 2029
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (1)