- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02576470
Motor Learning in Dysphagia Rehabilitation
Applying Motor Learning Principles to Dysphagia Rehabilitation R01DC014285
Study Overview
Status
Conditions
Detailed Description
The overall goal is to exploit motor learning principles in a novel way to enhance dysphagia rehabilitation in patients with dysphagia due to stroke. Dysphagia is swallowing impairment that can lead to serious illness or death due to ingested material entering the trachea (aspiration). Specifically, this study will determine whether lasting behavioral modifications after swallowing training occur with motor learning principles versus standard care. Motor learning principles emphasize continual kinematic assessment through biofeedback during training. However, continual kinematic assessment is rare in standard dysphagia care because swallowing kinematics require instrumentation such as videofluoroscopy (VF) to be seen. Since VF involves radiation exposure and higher costs, submental electromyography (sEMG) is widely used as biofeedback, although it does not image swallowing kinematics or confirm that a therapeutic movement is being trained. This research study will compare three forms of biofeedback on training swallowing maneuvers or compensatory techniques (referred to as targeted dysphagia training throughout this document) that might reduce their swallowing pathophysiology. VF biofeedback training will provide kinematic information about targeted dysphagia training performance, incorporating motor learning principles. sEMG biofeedback training will provide non-kinematic information about targeted dysphagia training performance and, thus, does not incorporate motor learning principles. A mixed biofeedback training, which involves VF biofeedback early on to establish the target kinematics of the targeted dysphagia training maneuver, then reinforces what was learned with sEMG. Mixed biofeedback training is being examined because it is more clinically feasible than VF biofeedback training, while still incorporating motor learning principles during part of the targeted dysphagia training.
The investigators hypothesize that VF training will reduce swallowing impairment more than mixed training, but mixed training will reduce swallowing impairment more than sEMG training. Additionally, this study will investigate whether adjuvant techniques known to augment motor training (non-invasive neural stimulation and explicit reward tested independently), will augment outcomes of each of the proposed training's. This innovative experimental design is significant because it investigates motor learning principles within an ideal training (VF biofeedback) as well as within a clinically feasible option (mixed biofeedback) to differentiate them from standard dysphagia training (sEMG), which has reported little to no improvements after intense motor training.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32610
- University of Florida Dental Tower Room 130 (DG130)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- swallowing problem
Exclusion Criteria:
- pregnant
- allergy to barium
- moderate to severe dementia
- serious respiratory illness
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Videofluoroscopy (VF) and Barium
This group will receive the following types of procedures during visits.
Videofluoroscopy (VF) and Barium to provide biofeedback for targeted dysphagia swallowing maneuver.
|
Motor learning is improvement in movement overtime, followed by retaining what was learned.
To determine whether movements are improving, kinematics must be assessed over time, beginning with defining specific kinematic goals, then continually re-evaluating goals throughout rehabilitation while providing the participants with biofeedback.
Biofeedback is fundamental in motor learning, because it increases guidance and motivation, supplements losses in intrinsic feedback (proprioception), and facilitates generalization and retention.
Biofeedback enhances the training of novel movements and could be essential for training swallowing maneuvers.
Biofeedback training will occur 3 times.
training swallowing maneuvers or compensatory techniques (referred to as targeted dysphagia training throughout this document) that might reduce their swallowing pathophysiology
The videofluoroscopy (VF) and barium will be used to record swallowing in all participant groups.
This will capture full resolution VF images of all subjects in real time in the lateral view.
From the digital recording, image sequencing will be exported to an image processing computer system and archived.
The image intensifier will be focused on the lips, posterior pharyngeal wall, hard palate, and just below the upper esophageal sphincter (UES), providing a full view of the oral cavity and neck.
A simultaneously recorded time-code will facilitate frame-by-frame data analysis.
VF is the only option for visualizing swallowing kinematics during the pharyngeal swallow.
Other Names:
|
Active Comparator: Surface Electromyography (sEMG)
This group will receive the following types of procedures during visits.
sEMG images will be used to provide biofeedback for the targeted dysphagia swallowing maneuver.
|
Motor learning is improvement in movement overtime, followed by retaining what was learned.
To determine whether movements are improving, kinematics must be assessed over time, beginning with defining specific kinematic goals, then continually re-evaluating goals throughout rehabilitation while providing the participants with biofeedback.
Biofeedback is fundamental in motor learning, because it increases guidance and motivation, supplements losses in intrinsic feedback (proprioception), and facilitates generalization and retention.
Biofeedback enhances the training of novel movements and could be essential for training swallowing maneuvers.
Biofeedback training will occur 3 times.
training swallowing maneuvers or compensatory techniques (referred to as targeted dysphagia training throughout this document) that might reduce their swallowing pathophysiology
Submental Electromyography (sEMG) is used to train participants swallowing maneuvers.
Other Names:
|
Active Comparator: Mixed VF and sEMG
This group will receive the following types of procedures during visits.
Videofluoroscopy (VF) and Barium, and EMG images will be used to provide biofeedback for the targeted dysphagia swallowing maneuver.
|
Motor learning is improvement in movement overtime, followed by retaining what was learned.
To determine whether movements are improving, kinematics must be assessed over time, beginning with defining specific kinematic goals, then continually re-evaluating goals throughout rehabilitation while providing the participants with biofeedback.
Biofeedback is fundamental in motor learning, because it increases guidance and motivation, supplements losses in intrinsic feedback (proprioception), and facilitates generalization and retention.
Biofeedback enhances the training of novel movements and could be essential for training swallowing maneuvers.
Biofeedback training will occur 3 times.
training swallowing maneuvers or compensatory techniques (referred to as targeted dysphagia training throughout this document) that might reduce their swallowing pathophysiology
The videofluoroscopy (VF) and barium will be used to record swallowing in all participant groups.
This will capture full resolution VF images of all subjects in real time in the lateral view.
From the digital recording, image sequencing will be exported to an image processing computer system and archived.
The image intensifier will be focused on the lips, posterior pharyngeal wall, hard palate, and just below the upper esophageal sphincter (UES), providing a full view of the oral cavity and neck.
A simultaneously recorded time-code will facilitate frame-by-frame data analysis.
VF is the only option for visualizing swallowing kinematics during the pharyngeal swallow.
Other Names:
Submental Electromyography (sEMG) is used to train participants swallowing maneuvers.
Other Names:
|
Experimental: VF with anodal tDCS
This group will receive the following types of procedures for biofeedback.
The biofeedback is based on videofluoroscopic (VF) and barium images with anodal transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS).
The anodal tDCS will be applied to the lesioned hemisphere during training.
|
Motor learning is improvement in movement overtime, followed by retaining what was learned.
To determine whether movements are improving, kinematics must be assessed over time, beginning with defining specific kinematic goals, then continually re-evaluating goals throughout rehabilitation while providing the participants with biofeedback.
Biofeedback is fundamental in motor learning, because it increases guidance and motivation, supplements losses in intrinsic feedback (proprioception), and facilitates generalization and retention.
Biofeedback enhances the training of novel movements and could be essential for training swallowing maneuvers.
Biofeedback training will occur 3 times.
training swallowing maneuvers or compensatory techniques (referred to as targeted dysphagia training throughout this document) that might reduce their swallowing pathophysiology
The videofluoroscopy (VF) and barium will be used to record swallowing in all participant groups.
This will capture full resolution VF images of all subjects in real time in the lateral view.
From the digital recording, image sequencing will be exported to an image processing computer system and archived.
The image intensifier will be focused on the lips, posterior pharyngeal wall, hard palate, and just below the upper esophageal sphincter (UES), providing a full view of the oral cavity and neck.
A simultaneously recorded time-code will facilitate frame-by-frame data analysis.
VF is the only option for visualizing swallowing kinematics during the pharyngeal swallow.
Other Names:
Weak direct currents can be applied non-invasively, transcranially and painlessly.
Such application leads to transient changes in corticomotor excitability that are fully reversible.
There are no known risks of tDCS of the brain, other than mild local discomfort at the electrode sites.The tDCS sessions will be separated by at least 24hrs, the electrode pads will not be used more than 4 times and they will be clean with a sterile saline solution.
Other Names:
Transcranial Magnetic Stimulation (TMS) will be used to provide a single-pulse to the brain.
Other Names:
|
Experimental: sEMG with anodal tDCS
This group will receive the following types of procedures for biofeedback.
The biofeedback is based on submental electromyography (sEMG) images with anodal transcranial direct current stimulation and transcranial magnetic stimulation (TMS).
The anodal tDCS will be applied to the lesioned hemisphere during training.
|
Motor learning is improvement in movement overtime, followed by retaining what was learned.
To determine whether movements are improving, kinematics must be assessed over time, beginning with defining specific kinematic goals, then continually re-evaluating goals throughout rehabilitation while providing the participants with biofeedback.
Biofeedback is fundamental in motor learning, because it increases guidance and motivation, supplements losses in intrinsic feedback (proprioception), and facilitates generalization and retention.
Biofeedback enhances the training of novel movements and could be essential for training swallowing maneuvers.
Biofeedback training will occur 3 times.
training swallowing maneuvers or compensatory techniques (referred to as targeted dysphagia training throughout this document) that might reduce their swallowing pathophysiology
Submental Electromyography (sEMG) is used to train participants swallowing maneuvers.
Other Names:
Weak direct currents can be applied non-invasively, transcranially and painlessly.
Such application leads to transient changes in corticomotor excitability that are fully reversible.
There are no known risks of tDCS of the brain, other than mild local discomfort at the electrode sites.The tDCS sessions will be separated by at least 24hrs, the electrode pads will not be used more than 4 times and they will be clean with a sterile saline solution.
Other Names:
Transcranial Magnetic Stimulation (TMS) will be used to provide a single-pulse to the brain.
Other Names:
|
Experimental: Mixed VF, sEMG with anodal tDCS
This group will receive the following types of procedures for biofeedback.
The biofeedback is based on videofluoroscopic (VF) and barium, and submental electromyography (sEMG) images with anodal transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS).
The anodal tDCS will be applied to the lesioned hemisphere during training.
|
Motor learning is improvement in movement overtime, followed by retaining what was learned.
To determine whether movements are improving, kinematics must be assessed over time, beginning with defining specific kinematic goals, then continually re-evaluating goals throughout rehabilitation while providing the participants with biofeedback.
Biofeedback is fundamental in motor learning, because it increases guidance and motivation, supplements losses in intrinsic feedback (proprioception), and facilitates generalization and retention.
Biofeedback enhances the training of novel movements and could be essential for training swallowing maneuvers.
Biofeedback training will occur 3 times.
training swallowing maneuvers or compensatory techniques (referred to as targeted dysphagia training throughout this document) that might reduce their swallowing pathophysiology
The videofluoroscopy (VF) and barium will be used to record swallowing in all participant groups.
This will capture full resolution VF images of all subjects in real time in the lateral view.
From the digital recording, image sequencing will be exported to an image processing computer system and archived.
The image intensifier will be focused on the lips, posterior pharyngeal wall, hard palate, and just below the upper esophageal sphincter (UES), providing a full view of the oral cavity and neck.
A simultaneously recorded time-code will facilitate frame-by-frame data analysis.
VF is the only option for visualizing swallowing kinematics during the pharyngeal swallow.
Other Names:
Submental Electromyography (sEMG) is used to train participants swallowing maneuvers.
Other Names:
Weak direct currents can be applied non-invasively, transcranially and painlessly.
Such application leads to transient changes in corticomotor excitability that are fully reversible.
There are no known risks of tDCS of the brain, other than mild local discomfort at the electrode sites.The tDCS sessions will be separated by at least 24hrs, the electrode pads will not be used more than 4 times and they will be clean with a sterile saline solution.
Other Names:
Transcranial Magnetic Stimulation (TMS) will be used to provide a single-pulse to the brain.
Other Names:
|
Sham Comparator: VF with sham tDCS
This group will receive the following types of procedures for biofeedback.
The biofeedback is based on videofluoroscopic (VF) and barium images without the transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS).
The tDCS will be applied during training, however no stimulation will be received.
|
Motor learning is improvement in movement overtime, followed by retaining what was learned.
To determine whether movements are improving, kinematics must be assessed over time, beginning with defining specific kinematic goals, then continually re-evaluating goals throughout rehabilitation while providing the participants with biofeedback.
Biofeedback is fundamental in motor learning, because it increases guidance and motivation, supplements losses in intrinsic feedback (proprioception), and facilitates generalization and retention.
Biofeedback enhances the training of novel movements and could be essential for training swallowing maneuvers.
Biofeedback training will occur 3 times.
training swallowing maneuvers or compensatory techniques (referred to as targeted dysphagia training throughout this document) that might reduce their swallowing pathophysiology
The videofluoroscopy (VF) and barium will be used to record swallowing in all participant groups.
This will capture full resolution VF images of all subjects in real time in the lateral view.
From the digital recording, image sequencing will be exported to an image processing computer system and archived.
The image intensifier will be focused on the lips, posterior pharyngeal wall, hard palate, and just below the upper esophageal sphincter (UES), providing a full view of the oral cavity and neck.
A simultaneously recorded time-code will facilitate frame-by-frame data analysis.
VF is the only option for visualizing swallowing kinematics during the pharyngeal swallow.
Other Names:
Weak direct currents can be applied non-invasively, transcranially and painlessly.
Such application leads to transient changes in corticomotor excitability that are fully reversible.
There are no known risks of tDCS of the brain, other than mild local discomfort at the electrode sites.The tDCS sessions will be separated by at least 24hrs, the electrode pads will not be used more than 4 times and they will be clean with a sterile saline solution.
Other Names:
Transcranial Magnetic Stimulation (TMS) will be used to provide a single-pulse to the brain.
Other Names:
|
Sham Comparator: sEMG with sham tDCS
This group will receive the following types of procedures for biofeedback.
The biofeedback is based on submental electromyography (sEMG) images without the transcranial direct current stimulation and transcranial magnetic stimulation (TMS).
The tDCS will be applied during training, however no stimulation will be received.
|
Motor learning is improvement in movement overtime, followed by retaining what was learned.
To determine whether movements are improving, kinematics must be assessed over time, beginning with defining specific kinematic goals, then continually re-evaluating goals throughout rehabilitation while providing the participants with biofeedback.
Biofeedback is fundamental in motor learning, because it increases guidance and motivation, supplements losses in intrinsic feedback (proprioception), and facilitates generalization and retention.
Biofeedback enhances the training of novel movements and could be essential for training swallowing maneuvers.
Biofeedback training will occur 3 times.
training swallowing maneuvers or compensatory techniques (referred to as targeted dysphagia training throughout this document) that might reduce their swallowing pathophysiology
Submental Electromyography (sEMG) is used to train participants swallowing maneuvers.
Other Names:
Weak direct currents can be applied non-invasively, transcranially and painlessly.
Such application leads to transient changes in corticomotor excitability that are fully reversible.
There are no known risks of tDCS of the brain, other than mild local discomfort at the electrode sites.The tDCS sessions will be separated by at least 24hrs, the electrode pads will not be used more than 4 times and they will be clean with a sterile saline solution.
Other Names:
Transcranial Magnetic Stimulation (TMS) will be used to provide a single-pulse to the brain.
Other Names:
|
Sham Comparator: Mixed VF, sEMG with sham tDCS
This group will receive the following types of procedures for biofeedback.
The biofeedback is based on videofluoroscopic (VF) and barium, and submental electromyography (sEMG) images without transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS).
The tDCS will be applied during training, however no stimulation will be received.
|
Motor learning is improvement in movement overtime, followed by retaining what was learned.
To determine whether movements are improving, kinematics must be assessed over time, beginning with defining specific kinematic goals, then continually re-evaluating goals throughout rehabilitation while providing the participants with biofeedback.
Biofeedback is fundamental in motor learning, because it increases guidance and motivation, supplements losses in intrinsic feedback (proprioception), and facilitates generalization and retention.
Biofeedback enhances the training of novel movements and could be essential for training swallowing maneuvers.
Biofeedback training will occur 3 times.
training swallowing maneuvers or compensatory techniques (referred to as targeted dysphagia training throughout this document) that might reduce their swallowing pathophysiology
The videofluoroscopy (VF) and barium will be used to record swallowing in all participant groups.
This will capture full resolution VF images of all subjects in real time in the lateral view.
From the digital recording, image sequencing will be exported to an image processing computer system and archived.
The image intensifier will be focused on the lips, posterior pharyngeal wall, hard palate, and just below the upper esophageal sphincter (UES), providing a full view of the oral cavity and neck.
A simultaneously recorded time-code will facilitate frame-by-frame data analysis.
VF is the only option for visualizing swallowing kinematics during the pharyngeal swallow.
Other Names:
Submental Electromyography (sEMG) is used to train participants swallowing maneuvers.
Other Names:
Weak direct currents can be applied non-invasively, transcranially and painlessly.
Such application leads to transient changes in corticomotor excitability that are fully reversible.
There are no known risks of tDCS of the brain, other than mild local discomfort at the electrode sites.The tDCS sessions will be separated by at least 24hrs, the electrode pads will not be used more than 4 times and they will be clean with a sterile saline solution.
Other Names:
Transcranial Magnetic Stimulation (TMS) will be used to provide a single-pulse to the brain.
Other Names:
|
Experimental: VF with reward
This group will receive the following the procedure outlined below for biofeedback.
The biofeedback is based on the videofluoroscopy (VF) and Barium with financial reward.
|
Motor learning is improvement in movement overtime, followed by retaining what was learned.
To determine whether movements are improving, kinematics must be assessed over time, beginning with defining specific kinematic goals, then continually re-evaluating goals throughout rehabilitation while providing the participants with biofeedback.
Biofeedback is fundamental in motor learning, because it increases guidance and motivation, supplements losses in intrinsic feedback (proprioception), and facilitates generalization and retention.
Biofeedback enhances the training of novel movements and could be essential for training swallowing maneuvers.
Biofeedback training will occur 3 times.
training swallowing maneuvers or compensatory techniques (referred to as targeted dysphagia training throughout this document) that might reduce their swallowing pathophysiology
The videofluoroscopy (VF) and barium will be used to record swallowing in all participant groups.
This will capture full resolution VF images of all subjects in real time in the lateral view.
From the digital recording, image sequencing will be exported to an image processing computer system and archived.
The image intensifier will be focused on the lips, posterior pharyngeal wall, hard palate, and just below the upper esophageal sphincter (UES), providing a full view of the oral cavity and neck.
A simultaneously recorded time-code will facilitate frame-by-frame data analysis.
VF is the only option for visualizing swallowing kinematics during the pharyngeal swallow.
Other Names:
Motor learning training can be enhanced by adjuvant techniques such as non-invasive neural stimulation and explicit reward.
Both influence the primary motor cortex (M1), a key neural substrate of motor skill learning.
Non-invasive neural stimulation reduces dysphagia after stroke as measured with subjective swallowing severity scales, however it is unknown whether it could also enhance swallowing maneuver training.
Explicit reward (i.e.
financial) incentivizes successful gains during motor training.
Explicit reward has never been investigated in swallowing rehabilitation.
However, it has been shown that increasing stress and financial penalty can reduce swallowing frequency in healthy adults.
Other Names:
|
Experimental: sEMG with financial reward
This group will receive the following types of procedures for biofeedback.
The biofeedback is based on submental electromyography (sEMG) images with financial reward.
The financial reward will only be done for 3-days.
|
Motor learning is improvement in movement overtime, followed by retaining what was learned.
To determine whether movements are improving, kinematics must be assessed over time, beginning with defining specific kinematic goals, then continually re-evaluating goals throughout rehabilitation while providing the participants with biofeedback.
Biofeedback is fundamental in motor learning, because it increases guidance and motivation, supplements losses in intrinsic feedback (proprioception), and facilitates generalization and retention.
Biofeedback enhances the training of novel movements and could be essential for training swallowing maneuvers.
Biofeedback training will occur 3 times.
training swallowing maneuvers or compensatory techniques (referred to as targeted dysphagia training throughout this document) that might reduce their swallowing pathophysiology
Submental Electromyography (sEMG) is used to train participants swallowing maneuvers.
Other Names:
Motor learning training can be enhanced by adjuvant techniques such as non-invasive neural stimulation and explicit reward.
Both influence the primary motor cortex (M1), a key neural substrate of motor skill learning.
Non-invasive neural stimulation reduces dysphagia after stroke as measured with subjective swallowing severity scales, however it is unknown whether it could also enhance swallowing maneuver training.
Explicit reward (i.e.
financial) incentivizes successful gains during motor training.
Explicit reward has never been investigated in swallowing rehabilitation.
However, it has been shown that increasing stress and financial penalty can reduce swallowing frequency in healthy adults.
Other Names:
|
Experimental: Mixed VF, sEMG with financial reward
This group will receive the following types of procedures for biofeedback.
The biofeedback is based on videofluoroscopic (VF) and barium, and submental electromyography (sEMG) images with financial reward.
The financial reward will only be done for 3 days.
|
Motor learning is improvement in movement overtime, followed by retaining what was learned.
To determine whether movements are improving, kinematics must be assessed over time, beginning with defining specific kinematic goals, then continually re-evaluating goals throughout rehabilitation while providing the participants with biofeedback.
Biofeedback is fundamental in motor learning, because it increases guidance and motivation, supplements losses in intrinsic feedback (proprioception), and facilitates generalization and retention.
Biofeedback enhances the training of novel movements and could be essential for training swallowing maneuvers.
Biofeedback training will occur 3 times.
training swallowing maneuvers or compensatory techniques (referred to as targeted dysphagia training throughout this document) that might reduce their swallowing pathophysiology
The videofluoroscopy (VF) and barium will be used to record swallowing in all participant groups.
This will capture full resolution VF images of all subjects in real time in the lateral view.
From the digital recording, image sequencing will be exported to an image processing computer system and archived.
The image intensifier will be focused on the lips, posterior pharyngeal wall, hard palate, and just below the upper esophageal sphincter (UES), providing a full view of the oral cavity and neck.
A simultaneously recorded time-code will facilitate frame-by-frame data analysis.
VF is the only option for visualizing swallowing kinematics during the pharyngeal swallow.
Other Names:
Submental Electromyography (sEMG) is used to train participants swallowing maneuvers.
Other Names:
Motor learning training can be enhanced by adjuvant techniques such as non-invasive neural stimulation and explicit reward.
Both influence the primary motor cortex (M1), a key neural substrate of motor skill learning.
Non-invasive neural stimulation reduces dysphagia after stroke as measured with subjective swallowing severity scales, however it is unknown whether it could also enhance swallowing maneuver training.
Explicit reward (i.e.
financial) incentivizes successful gains during motor training.
Explicit reward has never been investigated in swallowing rehabilitation.
However, it has been shown that increasing stress and financial penalty can reduce swallowing frequency in healthy adults.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
8-Point Penetration-Aspiration scale (P-A scale) will be used to swallowing ability
Time Frame: Changes from 24 hrs, 1 week, 1 month
|
The P-A scale is measured on a score of 1 - 8 with 1 being the best possible score - material does not enter the airway, to 8 being the worse score - material enters the airway, passes below the vocal folds, and no effort is made to eject.
|
Changes from 24 hrs, 1 week, 1 month
|
Targeted dysphagia training biofeedback using VF images will be used to determine the changes from 24 hours, 1 week, and 1 month
Time Frame: Changes from 24 hours, 1 week, and 1 month
|
VF biofeedback training group will test an ideal treatment circumstance using motor learning principles, where kinematic biofeedback is provided throughout training.
|
Changes from 24 hours, 1 week, and 1 month
|
Targeted dysphagia training biofeedback using sEMG measures will be used to determine the changes from 24 hours, 1 week and 1 month
Time Frame: Changes from 24 hours, 1 week, and 1 month
|
The sEMG biofeedback training will be acquired with surface electrodes placed on the face and/or neck using the Dual Bio Amp (ADInstruments).
|
Changes from 24 hours, 1 week, and 1 month
|
Targeted dysphagia training biofeedback using both VF and sEMG measures will be used to determine the changes from 24 hours, 1 week and 1 month
Time Frame: Changes from 24 hours, 1 week, and 1 month
|
The mixed biofeedback training will be recorded with sEMG for comparison with VF data.
|
Changes from 24 hours, 1 week, and 1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Training bolus targeted dysphagia maneuvers changes from 24 hours, 1 week, and 1 month
Time Frame: Changes from 24 hours, 1 week, and 1 month
|
Bolus targeted dysphagia training maneuvers will be trained to determine whether skills learned during saliva targeted dysphagia maneuver training transfer to the bolus targeted dysphagia maneuver context.
The bolus targeted dysphagia maneuver will be analyzed with a linear mixed-effects model to estimate the effect of training group.
|
Changes from 24 hours, 1 week, and 1 month
|
Kinematic analysis will be performed on targeted dysphagia maneuver changes from 24 hours, 1 week, and 1 month.
Time Frame: Changes from 24 hours, 1 week, and 1 month
|
Kinematic measures will include LVC duration, LVC response time (LVCrt), and sequence of bolus flow and LVC events.
LVC is defined as the first frame when the inverted epiglottis has approximated the arytenoids, resulting in no airspace within the hyo-laryngeal structures on a lateral view, until the first frame when airspace returns and the structures begin to separate.
Kinematic measure will be analyzed with a linear mixed-effects model to estimate the effect of training group.
|
Changes from 24 hours, 1 week, and 1 month
|
Training effect on financial reward analysis between 3 groups
Time Frame: Changes from days 1, 2, and 3
|
The financial reward will be analyzed by using a power calculation and is based on preliminary data where financial reward increased training effect by 344%, yielding a power calculation of 8 participants for each of the 3 training groups (24 participants).
|
Changes from days 1, 2, and 3
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Inaessa A Humbert, Ph.D., University of Florida
- Principal Investigator: Susan Nittrouer, Ph.D., University of Florida
Publications and helpful links
General Publications
- Azola AM, Greene LR, Taylor-Kamara I, Macrae P, Anderson C, Humbert IA. The Relationship Between Submental Surface Electromyography and Hyo-Laryngeal Kinematic Measures of Mendelsohn Maneuver Duration. J Speech Lang Hear Res. 2015 Dec;58(6):1627-36. doi: 10.1044/2015_JSLHR-S-14-0203.
- Macrae P, Anderson C, Taylor-Kamara I, Humbert I. The effects of feedback on volitional manipulation of airway protection during swallowing. J Mot Behav. 2014;46(2):133-9. doi: 10.1080/00222895.2013.878303. Epub 2014 Feb 14.
- Humbert IA, German RZ. New directions for understanding neural control in swallowing: the potential and promise of motor learning. Dysphagia. 2013 Mar;28(1):1-10. doi: 10.1007/s00455-012-9432-y. Epub 2012 Nov 30.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB201500742-N
- 14BGIA20380348 (Other Grant/Funding Number: American Heart Association)
- 1R01DC014285-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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University of CincinnatiMedical University of South Carolina; University of California, Los Angeles; University...RecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke HemorrhagicUnited States
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Turkish Stroke Research and Clinical Trials NetworkElectroCore INC; Turkish Neurological SocietyCompletedStroke | Stroke, Ischemic | Stroke, Acute | Stroke, HemorrhagicTurkey
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University of LiegeCompletedStroke, Acute | Stroke Hemorrhagic | Stroke, ComplicationBelgium
Clinical Trials on Biofeedback
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Technische Universität DresdenMichael J. Fox Foundation for Parkinson's Research; University Hospital Carl...CompletedAutonomic Dysfunction | Acute Ischaemic StrokeGermany
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Klick Inc.Completed
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L. Eugene ArnoldNational Institute of Mental Health (NIMH); Brain Resource CenterCompletedAttention Deficit Hyperactivity DisorderUnited States
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Icahn School of Medicine at Mount SinaiRecruitingMajor Depressive DisorderUnited States
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The Hong Kong Polytechnic UniversityKwong Wah HospitalCompleted
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Badr UniversityCompletedFecal Incontinence in ChildrenEgypt
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New York UniversityNational Institute on Deafness and Other Communication Disorders (NIDCD); Syracuse... and other collaboratorsCompletedSpeech Sound DisorderUnited States
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Rutgers, The State University of New JerseyArthritis FoundationCompleted
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British Columbia Cancer AgencyUniversity of British ColumbiaSuspended
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Emory UniversityNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedAnterior Cruciate Ligament InjuriesUnited States