Deglutition Disorders
Conditions
Brief summary
Wearable tele-rehabilitation technology allows for the efficient provision of rehabilitation services from a distance, facilitating tele-management of many disorders. The proposed research will develop and validate a set of mechanically compliant, easy-to-use, and inexpensive wearable tele-monitoring systems, for future use in the rehabilitation of swallowing disorders (dysphagia). The hypothesis is that the newly developed wearable sensors will have equal or better performance than traditional wired sensors used today in clinical practice. Factors related to signal quality and patient reported outcomes (e.g., satisfaction/comfort level, adverse effects etc.) will be examined.
Interventions
DEVICETele-EaT Sensors
Two iterations of a wearable surface EMG (sEMG) sensors patch we developed will be tested against commercially available wired devices. The first iteration of the wearable sensor patch is an ultrathin patch with a honeycomb-inspired design that included sEMG and strain sensors in order to capture muscle activity and thyroid movement signals from the submental area during swallows and swallow maneuvers/exercises. The second iteration is a more durable slightly thicker flexible, non-stretchable, and double-sided thin sEMG patch. Participants will perform standardized swallow tasks while wearing the device.
DEVICEConventional Sensors
Conventional sensors will include snap-on wired electrodes as the control condition. The same set of standardized swallow tasks will be completed with the conventional and commercially available devices as well.
Sponsors
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Purdue University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Experiments will follow a within-subject randomized cross-over design. The purpose is to develop devices that are optimized for their use. To achieve this goal, for each new iteration of the devices, at least ten new participants will be tested using the current prototypes and the commercially available counterpart sensors in counterbalanced order. Results will be analyzed and discussed in regards to design improvements before the next iteration of development. The plan to recruit a large number of total subjects allows for several pre-clinical experiments to be conducted until the final versions of both devices are optimized.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion criteria for healthy adults: * Age 18-30 OR 50-90 years of age * No history of dysphagia * No history of a neurological disorder * A score in the normal/mild range on the Montreal Cognitive Assessment (MoCA): * A score of \<3 on the Eating Assessment Tool-10 (EAT-10, a self-report screening for dysphagia). Inclusion criteria for patients with dysphagia: * Age 18-90 years of age * Diagnoses of dysphagia as a result of a neurological disorder (e.g., stroke, Parkinson's disease). * A score in the normal/mild range on the Montreal Cognitive Assessment (MoCA). * A score of ≥3 on the Eating Assessment Tool-10 (EAT-10, a self-report screening for dysphagia).
Exclusion criteria
• Significant cognitive impairment (a score in the moderate-severe range on MoCA):
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Normalized Task-related sEMG Amplitude (Signal Quality Parameter) | Post each experiment (i.e., 1 hour after the sensors have been placed) | Normalized sEMG amplitude values during standardized swallow tasks and maneuvers will be recorded and compared between the two sEMG devices. Normalized amplitude is used as a signal quality parameter and is not a health related outcome. |
| Signal to Noise Ratio (Signal Quality Parameter) | Post each experiment (i.e., 1 hour after the sensors have been placed) | Signal to Noise ratio will be calculated and compared between sensor types tested. Signal to noise ration is a signal quality parameter and not a health related outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ease of Use/Comfort | Post each experiment (i.e., 1 hour after the sensors have been placed) | Ease-of-use/comfort will be examined using a survey also devised by the investigators (using a positive centered 5-point Likert scale) with questions about ease-of-use/comfort after each experiment with each device. This survey includes statements related to the participants' ease-of-use/comfort during the experimental protocol (e.g., I was comfortable while the experimenter placed the sensors on my skin). The answers will be rated on a 10-point scale (i.e., 1 = extremely uncomfortable, 10 = extremely comfortable). Higher values indicate better or higher satisfaction/comfort scores. Total scores will be compared across conditions/devices tested. For the first iteration testing, the scale used for this outcome measure included 5 survey questions rated on a 10-point scale (total possible: 50; range 0-50). For the second iteration testing, we added one more question, hence the scale included 6 survey questions (total possible: 60; range: 0-60). |
| Adverse Effects and Safety | Pre and Post each experiment (i.e., right before the placement of sensors on the subject and 1 hour after the sensors have been placed and 5 minutes after their removal) | Safety will be examined by documenting the incidence of skin irritations and pain in the subjects. A visual inspection form including a binary scale (YES/NO) has been devised by the investigators (no formal name) and will be used by a rater who will thoroughly inspect the participants' submandibular skin before and after each experiment. For any irritation or change in appearance YES will be selected and the type of irritation will be descriptively recorded (e.g., red skin). Pain is also rated in the same way through a question to the participants. This form will be completed by a rater who is not part of the data collection process and who is blinded to sensors type to avoid any bias.The number of YESs will be used to calculate the incidence of these adverse effects in the sample. |
Countries
United States
Participant flow
Recruitment details
Two iterations of the sensors were tested against commercial sensors. For iteration 1, 51 healthy older adults were screened for eligibility between September and November 2018. For iteration 2, 38 healthy older adults were screened for eligibility between October 2021 and March 2023. All was completed at a university research lab and clinic in West Lafayette, Indiana.
Pre-assignment details
For iteration 1, 40 of the 51 participants were randomized into one of 2 groups for testing 1. Of those not randomized, 7 did not meet inclusion criteria, 1 declined to participate, and 1 did not participate due to other reasons (scheduling conflicts or technical issues). For iteration 2, 30 of the 38 participants were randomized into one of 2 groups for testing 2. Of those not randomized, 7 did not meet inclusion criteria, and 1 did not participate due to other reasons (technical issues).
Participants by arm
| Arm | Count |
|---|---|
| Group A1: Conventional Sensors First, Then Experimental (Tele-EaT) Sensors - Iteration 1 Group A1 participants completed the experimental protocol (swallow trials) with the conventional (commercially available) electrodes/sensors first. After a break of 10 minutes, they then repeated the exact same experimental protocol (exact same swallow trials) with the first iteration of the experimental sensors (i.e., a wearable surface EMG sensors patch we are developing).
Tele-EaT Sensors - Iteration 1: A first iteration of a wearable surface EMG (sEMG) sensors patch we developed was tested against commercially available wired devices. The first iteration of the wearable sensor patch is an ultrathin patch with a honeycomb-inspired design that included sEMG and strain sensors in order to capture muscle activity and thyroid movement signals from the submental area during swallows and swallow maneuvers/exercises. Participants performed standardized swallow tasks while wearing the first iteration device.
Conventional Sensors: Conventional sensors included snap-on wired electrodes as the control condition. The same set of standardized swallow tasks was completed with the conventional and commercially available devices as well. | 20 |
| Group B1: Experimental (Tele-EaT) Sensors - Iteration 1 First, Then Conventional Sensors Group B1 participants completed the experimental protocol (swallow trials) with the first iteration of the experimental sensors (i.e., a wearable surface EMG sensors patch we are developing) first. After a break of 10 minutes, they then repeated the exact same experimental protocol (exact same swallow trials) with the conventional (commercially available) electrodes/sensors.
Tele-EaT Sensors -Iteration 1: The first iteration of a wearable surface EMG (sEMG) sensors patch we developed was tested against commercially available wired devices. The first iteration of the wearable sensor patch is an ultrathin patch with a honeycomb-inspired design that included sEMG and strain sensors in order to capture muscle activity and thyroid movement signals from the submental area during swallows and swallow maneuvers/exercises. Participants performed standardized swallow tasks while wearing the device.
Conventional Sensors: Conventional sensors included snap-on wired electrodes as the control condition. The same set of standardized swallow tasks was completed with the conventional and commercially available devices as well. | 20 |
| Group A2: Conventional Sensors First, Then Experimental (Tele-EaT) Sensors - Iteration 2 Group A2 participants completed the experimental protocol (swallow trials) with the conventional (commercially available) electrodes/sensors first. After a break of 10 minutes, they then repeated the exact same experimental protocol (exact same swallow trials) with the second iteration of the experimental sensors (i.e., a wearable surface EMG sensors patch we are developing).
Tele-EaT Sensors - Iteration 2: A second improved iteration of a wearable surface EMG (sEMG) sensors patch we developed was tested against commercially available wired devices. The second iteration of the wearable sensor patch is a more durable slightly thicker flexible, non-stretchable, and double-sided thin sEMG patch. Participants performed standardized swallow tasks while wearing the second iteration device.
Conventional Sensors: Conventional sensors included snap-on wired electrodes as the control condition. The same set of standardized swallow tasks was completed with the conventional and commercially available devices as well. | 15 |
| Group B2: Experimental (Tele-EaT) Sensors - Iteration 2 First, Then Conventional Sensors Group B2 participants completed the experimental protocol (swallow trials) with the second iteration of the experimental sensors (i.e., a wearable surface EMG sensors patch we are developing) first. After a break of 10 minutes, they then repeated the exact same experimental protocol (exact same swallow trials) with the conventional (commercially available) electrodes/sensors.
Tele-EaT Sensors - Iteration 2: The second improved iteration of a wearable surface EMG (sEMG) sensors patch we developed was tested against commercially available wired devices. The second iteration of the wearable sensor patch is a more durable slightly thicker flexible, non-stretchable, and double-sided thin sEMG patch. Participants performed standardized swallow tasks while wearing the device.
Conventional Sensors: Conventional sensors included snap-on wired electrodes as the control condition. The same set of standardized swallow tasks was completed with the conventional and commercially available devices as well. | 15 |
| Total | 70 |
Baseline characteristics
| Characteristic | Total | Group B1: Experimental (Tele-EaT) Sensors - Iteration 1 First, Then Conventional Sensors | Group A2: Conventional Sensors First, Then Experimental (Tele-EaT) Sensors - Iteration 2 | Group A1: Conventional Sensors First, Then Experimental (Tele-EaT) Sensors - Iteration 1 | Group B2: Experimental (Tele-EaT) Sensors - Iteration 2 First, Then Conventional Sensors |
|---|---|---|---|---|---|
| Age, Continuous | 66.3 Years STANDARD_DEVIATION 8.5 | 68.3 Years STANDARD_DEVIATION 6.7 | 63.6 Years STANDARD_DEVIATION 10 | 66.5 Years STANDARD_DEVIATION 8.8 | 65.7 Years STANDARD_DEVIATION 8.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 68 Participants | 20 Participants | 15 Participants | 20 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 66 Participants | 20 Participants | 15 Participants | 19 Participants | 12 Participants |
| Region of Enrollment United States | 70 Participants | 20 Participants | 15 Participants | 20 Participants | 15 Participants |
| Sex: Female, Male Female | 29 Participants | 11 Participants | 7 Participants | 5 Participants | 6 Participants |
| Sex: Female, Male Male | 41 Participants | 9 Participants | 8 Participants | 15 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 8 / 40 | 1 / 40 | 12 / 30 | 4 / 30 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 | 0 / 30 | 0 / 30 |
Outcome results
Primary
Normalized Task-related sEMG Amplitude (Signal Quality Parameter)
Normalized sEMG amplitude values during standardized swallow tasks and maneuvers will be recorded and compared between the two sEMG devices. Normalized amplitude is used as a signal quality parameter and is not a health related outcome.
Time frame: Post each experiment (i.e., 1 hour after the sensors have been placed)
Population: Reminder: The first iteration testing of the Tele-EaT sensors was tested against commercial/conventional sensors in 40 participants. The second iteration testing was tested in an additional 30 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Sensors - Iteration Testing 1 | Normalized Task-related sEMG Amplitude (Signal Quality Parameter) | 12.5 percentage of maximum amplitude | Standard Deviation 7 |
| Tele-EaT Sensors - Iteration Testing 1 | Normalized Task-related sEMG Amplitude (Signal Quality Parameter) | 11.7 percentage of maximum amplitude | Standard Deviation 7.3 |
| Conventional Sensors - Iteration Testing 2 | Normalized Task-related sEMG Amplitude (Signal Quality Parameter) | 17.3 percentage of maximum amplitude | Standard Deviation 8 |
| Tele-EaT Sensors - Iteration Testing 2 | Normalized Task-related sEMG Amplitude (Signal Quality Parameter) | 13.8 percentage of maximum amplitude | Standard Deviation 6.2 |
Comparison: For Iteration 1 testing, we hypothesized that normalized amplitude during swallow trials obtained using the conventional sensors and the experimental sensors will be equivalent. Alpha level was set to .025 to correct for multiple comparisons.p-value: <0.025t-test, 2 sided
Comparison: For Iteration 2 testing again, we hypothesized that normalized amplitude during swallow trials obtained using the conventional sensors and the experimental sensors will be equivalent. Alpha level was set to .025 to correct for multiple comparisons.p-value: <0.025Bootstrapping CIs
Primary
Signal to Noise Ratio (Signal Quality Parameter)
Signal to Noise ratio will be calculated and compared between sensor types tested. Signal to noise ration is a signal quality parameter and not a health related outcome.
Time frame: Post each experiment (i.e., 1 hour after the sensors have been placed)
Population: Reminder: The first iteration testing of the Tele-EaT sensors was tested against commercial/conventional sensors in 40 participants. The second iteration testing was tested in an additional 30 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Sensors - Iteration Testing 1 | Signal to Noise Ratio (Signal Quality Parameter) | 19.5 Signal to noise ratio | Standard Deviation 5.2 |
| Tele-EaT Sensors - Iteration Testing 1 | Signal to Noise Ratio (Signal Quality Parameter) | 20.4 Signal to noise ratio | Standard Deviation 5 |
| Conventional Sensors - Iteration Testing 2 | Signal to Noise Ratio (Signal Quality Parameter) | 25.1 Signal to noise ratio | Standard Deviation 5.5 |
| Tele-EaT Sensors - Iteration Testing 2 | Signal to Noise Ratio (Signal Quality Parameter) | 26.7 Signal to noise ratio | Standard Deviation 3.9 |
Comparison: For Iteration 1 testing, we hypothesized that Signal to Noise Ratio (SNR) obtained using the experimental sensors will not be inferior to the Signal to Noise Ratio (SNR) obtained using the conventional sensors. Alpha level was set to .025 to correct for multiple comparisons.p-value: <0.025t-test, 1 sided
Comparison: For Iteration 2 testing, we again hypothesized that Signal to Noise Ratio (SNR) obtained using the newer version of the experimental sensors will not be inferior to the Signal to Noise Ratio (SNR) obtained using the conventional sensors. Alpha level was set to .025 to correct for multiple comparisons.p-value: <0.025Bootstrapping CIs
Secondary
Adverse Effects and Safety
Safety will be examined by documenting the incidence of skin irritations and pain in the subjects. A visual inspection form including a binary scale (YES/NO) has been devised by the investigators (no formal name) and will be used by a rater who will thoroughly inspect the participants' submandibular skin before and after each experiment. For any irritation or change in appearance YES will be selected and the type of irritation will be descriptively recorded (e.g., red skin). Pain is also rated in the same way through a question to the participants. This form will be completed by a rater who is not part of the data collection process and who is blinded to sensors type to avoid any bias.The number of YESs will be used to calculate the incidence of these adverse effects in the sample.
Time frame: Pre and Post each experiment (i.e., right before the placement of sensors on the subject and 1 hour after the sensors have been placed and 5 minutes after their removal)
Population: Reminder: The first iteration testing of the Tele-EaT sensors was tested against commercial/conventional sensors in 40 participants. The second iteration testing was tested in an additional 30 participants. For this outcome measure, cumulative data across both time points are presented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Conventional Sensors - Iteration Testing 1 | Adverse Effects and Safety | 8 Participants |
| Tele-EaT Sensors - Iteration Testing 1 | Adverse Effects and Safety | 1 Participants |
| Conventional Sensors - Iteration Testing 2 | Adverse Effects and Safety | 12 Participants |
| Tele-EaT Sensors - Iteration Testing 2 | Adverse Effects and Safety | 4 Participants |
Secondary
Ease of Use/Comfort
Ease-of-use/comfort will be examined using a survey also devised by the investigators (using a positive centered 5-point Likert scale) with questions about ease-of-use/comfort after each experiment with each device. This survey includes statements related to the participants' ease-of-use/comfort during the experimental protocol (e.g., I was comfortable while the experimenter placed the sensors on my skin). The answers will be rated on a 10-point scale (i.e., 1 = extremely uncomfortable, 10 = extremely comfortable). Higher values indicate better or higher satisfaction/comfort scores. Total scores will be compared across conditions/devices tested. For the first iteration testing, the scale used for this outcome measure included 5 survey questions rated on a 10-point scale (total possible: 50; range 0-50). For the second iteration testing, we added one more question, hence the scale included 6 survey questions (total possible: 60; range: 0-60).
Time frame: Post each experiment (i.e., 1 hour after the sensors have been placed)
Population: The first iteration test of the Tele-EaT sensors against commercial/conventional sensors included 40 participants. The second iteration testing was tested in an additional 30 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Sensors - Iteration Testing 1 | Ease of Use/Comfort | 48.06 score on a scale | Standard Deviation 3.6 |
| Tele-EaT Sensors - Iteration Testing 1 | Ease of Use/Comfort | 48.62 score on a scale | Standard Deviation 3.2 |
| Conventional Sensors - Iteration Testing 2 | Ease of Use/Comfort | 54 score on a scale | Standard Deviation 8.3 |
| Tele-EaT Sensors - Iteration Testing 2 | Ease of Use/Comfort | 57 score on a scale | Standard Deviation 4.2 |
Comparison: For Iteration 1 testing, we hypothesized that ease of use/comfort expressed after using the experimental patch will be higher than the one reported using the conventional electrodes. Alpha level was set to .05.p-value: <0.05t-test, 1 sided
Comparison: For Iteration 2 testing, again we hypothesized that ease of use/comfort expressed after using the experimental patch will be higher than the one reported using the conventional electrodes. Alpha level was set to .05.p-value: <0.05t-test, 1 sided