Wearable Biofeedback for Swallowing Disorders Rehabilitation in Stroke and Parkinson Disease

Phase 2RecruitingNCT06638944

Purdue University120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

Interventions

In-person sEMG-biofeedbackBEHAVIORAL

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-biofeedbackBEHAVIORAL

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 treatmentBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Wearable Biofeedback for Swallowing Disorders Rehabilitation in Stroke and Parkinson Disease

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts