i-BiSSkApp for Swallowing Rehabilitation in Parkinson's Disease

April 19, 2023 updated by: University of South Florida

At-Home Skill Training Using Biofeedback for Swallowing Rehabilitation in Parkinson's Disease

Aspiration pneumonia due to dysphagia is a leading cause of death in Parkinson's disease (PD). Dysphagia intervention in the United States involves evaluation at onset of dysphagia symptoms followed by short-term therapy. Traditional therapy relies on verbal instruction and low-tech at-home exercise regimens without visual biofeedback; lacking a monitoring of accuracy or strength of exercise. Available biofeedback is office-based, bulky and expensive, thus, not readily used. The Biofeedback in Strength and Skill Training (BiSSKit) is a well-researched office based biofeedback system that has recently been converted into an affordable and accessible home-based application. This study aims to investigate the impact of swallowing therapy using the BiSSKit app on airway protective outcomes in patients with PD. Thirty participants with PD and dysphagia will be recruited for this study. Participants will undergo a baseline-modified barium swallowing (MBS) evaluation followed by 12 weekly sessions of swallowing therapy. Participants will be randomized to two swallowing therapy groups (1) traditional (2) BiSSKit app. Participants will undergo MBS following therapy completion. Outcome measures include swallowing safety, pharyngeal kinematics, and swallowing-related quality of life. We hypothesize that use of the BiSSKit will result in improved swallowing function compared to the traditional swallowing therapy group.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Dysphagia, or disordered swallowing, is prevalent in almost all neurodegenerative conditions and results in the inability to effectively protect the lower airways from foreign (i.e., food/liquid) and endogenous (i.e., saliva) material [1-3]. An unfortunate consequence of dysphagia is aspiration pneumonia, which is a leading cause of death in Parkinson's disease (PD) [4-6]. Swallowing therapy has proven to be effective for the management of dysphagic symptoms in PD. Treatment is most often delivered in clinics once/week over short time periods with the expectation that exercises be completed at-home. However, these paradigms lack biofeedback to assess the accuracy and strength of the prescribed exercise and accountability to ensure completion of the exercise program. Without biofeedback or options for long-term therapeutic intervention at-home, patients often regress to baseline levels [7-9]. The proposed research project seeks to test the effectiveness of a novel at-home surface electromyography (sEMG) biofeedback therapy tool called Biofeedback in Strength and Skill Training (BiSSKit) on swallowing safety and efficiency in patients with PD. The significance of this project lies in the fact that dysphagia is expensive in terms of patient quality of life, health outcomes, and healthcare costs [10, 11] often increasing hospital costs by approximately 40% [12]. Thus, a targeted swallowing therapy system with biofeedback that can be utilized at-home may reduce hospitalizations secondary to dysphagia, help maintain therapeutic gains, and reduce the burden that dysphagia places on our healthcare system.

sEMG is a therapy tool that has been used in rehabilitation practice for decades. Use of sEMG during swallowing therapy involves placement of electrodes under the chin (overlying the anterior belly of the digastric, mylohyoid and geniohyoid muscles) [13]. While the patient completes a swallowing task, electrodes detect collective muscle contractions associated with hyolaryngeal excursion - a biomechanical event critically important to airway safety and swallowing efficiency [14]. The patient can then see the waveform of the swallow displayed on a computer monitor. Measures of swallowing "strength" are derived from the amplitude of the waveform. sEMG hardware and associated software available in the marketplace today is cost prohibitive and thus, in the United States, only available for office-based swallowing intervention.

sEMG provides external biofeedback regarding swallowing parameters by activating neural networks controlling both motor execution and imagery of the act of swallowing including the pre- and postcentral gyrus, inferior frontal gyrus, basal ganglia, insula, and cerebellum [15]. Research has shown that exercise programs incorporating biofeedback promote significant physiologic change that is maintained over time in patients with dysphagia [14, 16-18]. Patients with PD benefit greatly from biofeedback exercises for respiratory muscle strength and lingual strengthening programs and have even been found to maintain the gains made in therapy with at-home programs [7, 16, 19].

A limitation of the currently available sEMG programs is that research studies have solely focus on the strength aspects of the swallowing (amplitude of the waveform) while failing to address the dynamic, skill-based parameters such as timing and volitional initiation that is captured in waveform morphology. Skill based swallowing training focuses on the precision of movements; and this is especially important for patients with PD [14]. Additionally, traditional sEMG systems in the US lack the ability for clinicians to modulate swallowing targets during tasks, which, according to principles of neuroplasticity, is essential for maximizing therapeutic results. The BiSSKit program is a well-researched office-based biofeedback system that adheres to principles of neuroplasticity and incorporates skill training in addition to strength training [14]. Developed in New Zealand and recently approved by the US FDA, this program has been converted into an affordable and accessible home-based application for tablet computers. This hybrid BiSSKiT system incorporates clinical visits and home-based skill/strength training and shows promise to change current therapy delivery models. Although exciting, there is a paucity of data regarding the use of the BiSSKiT with daily home therapy focused on strength and skill based swallowing training on changes to swallowing safety and efficiency in people with PD. This study seeks to evaluate the impact of this device on swallowing outcomes compared to traditional swallowing therapy models in PD.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • Univerity of South Florida
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Diagnosis of PD by a fellowship trained movement disorders neurologist
  2. Able to provide informed consent.
  3. Older than 18 years of age.
  4. Evidence of oropharyngeal swallowing deficits as determined during a standard of care MBSS.

Exclusion Criteria:

  1. Show evidence of cognitive impairment prohibiting completion of self-informed consent.
  2. Have a history of stroke or other traumatic brain injury.
  3. Have a history of previous dysphagia treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: i-BiSSkApp Group
This group will complete daily swallowing behavioral exercises with simultaneous at-home sEMG biofeedback using a tablet application. Participants will participate in weekly clinic visits and at-home therapy for 12 weeks.
Device: i-BiSSkApp (tablet application) with swallowing therapy
The device, "International Biofeedback Strength and Skill App (i-BiSSkApp)" is an at-home swallowing biofeedback tool (hardware and software) to target rehabilitation of both skill and strength of swallowing function. The program utilizes submental surface electromyography coupled with a user-friendly interface to display visual feedback of swallowing strength and timing.
Active Comparator: Traditional Treatment
This group will receive traditional swallowing therapy once a week for 12 weeks using standard therapy practices. They will also complete at-home daily practice of these exercises.
Behavioral: Traditional behavioral swallowing therapy
Participants will receive standard behavioral swallowing exercises based on the results of a swallowing evaluation. Participants will complete daily at-home exercises with written and verbal instructions and return weekly to clinic for 12 weeks of therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Penetration Aspiration Scale Score (PAS)
Time Frame: Baseline
8 point ordinal scale to assess swallowing safety.
Baseline
Penetration Aspiration Scale Score (PAS)
Time Frame: Post-12 weeks of intervention
8 point ordinal scale to assess swallowing safety.
Post-12 weeks of intervention
Total Pharyngeal Residue
Time Frame: Baseline
This is the amount of residue within the valleculae and piriform sinuses after the completion of a swallow.
Baseline
Total Pharyngeal Residue
Time Frame: Post-12 weeks of intervention
This is the amount of residue within the valleculae and piriform sinuses after the completion of a swallow.
Post-12 weeks of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eating Assessment Tool-10 (EAT-10)
Time Frame: Baseline
Validated quality of life measure of swallowing function.
Baseline
Eating Assessment Tool-10 (EAT-10)
Time Frame: Post-12 weeks of intervention
Validated quality of life measure of swallowing function.
Post-12 weeks of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Florida

Investigators

  • Principal Investigator: Stephanie Watts, PhD, University of South Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 15, 2023

Primary Completion (Anticipated)

May 31, 2024

Study Completion (Anticipated)

May 31, 2024

Study Registration Dates

First Submitted

April 6, 2023

First Submitted That Met QC Criteria

April 19, 2023

First Posted (Actual)

May 1, 2023

Study Record Updates

Last Update Posted (Actual)

May 1, 2023

Last Update Submitted That Met QC Criteria

April 19, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY005198

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data that underlie results reported in an article, after deidentification (text, tables, figures, and appendices). No specific data will be shared outside of study investigators.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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