The Passy Muir Swallowing Self Training Device to Enhance Recovery Post Stroke (PMSST)
The purpose of this study is to develop a vibratory self-trainer for the treatment of dysphagia post-stroke.
The aim is to identify the optimal stimulation characteristics for use with participants with swallowing problems including:
- Frequency of vibration
- Mode of vibration either continuous or pulsed
- Pressure of device against the neck
- Duration of vibration to allow a participant to initiate a swallow
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Pass-Muir Swallowing Self Training Device to Enhance Recovery Post Stroke|
- Frequency of swallowing [ Time Frame: During intervention. Each experimental session will last no more than 1 hour, participants can volunteer for 1-3 sessions. ] [ Designated as safety issue: No ]Outcome measure for Aim 1. Frequency of swallowing and time to initiate a swallow with stimulation will be measured to determine optimal stimulation characteristics of the vibratory device.
- Perceived urge to swallow [ Time Frame: During intervention. Each experimental session will last no more than 1 hour, participants can volunteer for 1-3 sessions. ] [ Designated as safety issue: No ]Outcome measure for Aim 1. Participants will mark on a VAS scale their perceived urge to swallow to determine optimal characteristics of the vibratory self-trainer.
|Study Start Date:||January 2013|
|Study Completion Date:||January 2016|
|Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
|Participants with swallowing deficits post stroke||
Device: Passy Muir Swallowing Self-Trainer
Comparison of the effects of different vibratory characteristics on the frequency of swallowing, time of initiation of swallowing with stimulation and urge to swallow. Will compare frequency of vibration, mode of vibration, pressure of device against neck, and duration of vibration. Each session will last no more than 1 hour with short breaks. Each participant can volunteer for up to three nonconsecutive sessions.
This study investigates the use of self-training device to improve swallowing post-stroke. The device has motors placed on the neck over each side of the thyroid cartilage and provides noninvasive vibratory stimulation. The vibration penetrates through the neck to the tissues in the larynx to activate mechanoreceptors innervated by the internal branch of the superior laryngeal nerve, which when stimulated will trigger swallowing at the brain stem level. The outcomes of this research will be used to develop a device for use by the patients for daily swallowing self-training in their own environment.
Site monitoring and auditing will be conducted at crucial time points during the study, including just prior to participant enrollment. Auditing will be conducted by Julie Kobak, Vice President for Clinical Education of Passy Muir , Inc.
Source data verification will be comparing raw data forms to electronic case report forms.
Standard operating procedures are in place for participant recruitment, data collection, data management, data analysis, and reporting adverse events.
Sample size assessment: Based on previous studies in healthy volunteers contrasting air puff stimulation on the rate of swallowing (1, 2) the expected change in rate of swallowing will be from 1.2 swallows/minute without stimulation to 2.0 swallows/minute with stimulation with a standard deviation of the differences being 0.9. Using a Bonferroni corrected alpha of 0.025 (to test 2 measures) at 0.80 power with an effect size of 0.88, the number of participants needed will be 15 per experiment. Allowing for some participants to participate in several studies, the investigators plan to recruit between 30 and 40 participants with risk of aspiration post stroke.
Potential problems and alternative strategies: Anticipated problems include difficulties with recruiting an adequate sample. There are 3 rooms available for participant testing at Rockingham Memorial Hospital to support multiple participants being tested simultaneously. Furthermore, all the equipment is portable including Powerlab, a laptop, the amplifier system, the Kistler accelerometers, and Inductive plethysmography so participants can be tested in rehabilitation settings and/or in their own home. Advertisements and a website have also been created.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01765673
|United States, Virginia|
|James Madison University and Rockingham Memorial Hospital|
|Harrisonburg, Virginia, United States, 22801|
|Principal Investigator:||Christy L Ludlow, PhD||James Madison University|