Motor Learning in Dysphagia Rehabilitation

Not Applicable

Terminated

Conditions: Swallowing Disorders
Deglutition Disorders
Stroke
Dysphagia

Interventions: Behavioral: Biofeedback
Behavioral: targeted dysphagia training maneuver
Device: Transcranial Direct Current Stimulation
Behavioral: Financial Reward
Radiation: Videofluoroscopy (VF) and Barium
Device: Submental Electromyography
Device: Transcranial Magnetic Stimulation

Registration Number: NCT02576470

Lead Sponsor: University of Florida

Brief Summary: The overall goal is to exploit motor learning principles and adjuvant techniques in a novel way to enhance dysphagia rehabilitation. The proposed study will investigate the effects of three forms of biofeedback on training and determine whether adjuvant therapeutic techniques such as non-invasive neural stimulation and reward augment training outcomes has an effect of dysphagia rehabilitation. Outcomes from this research study may change the paradigm for treating swallowing and other internal functions such as speech and voice disorders.

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 74

Inclusion Criteria

swallowing problem

Exclusion Criteria

pregnant
allergy to barium
moderate to severe dementia
serious respiratory illness

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mixed VF and sEMG	Videofluoroscopy (VF) and Barium	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.
Videofluoroscopy (VF) and Barium	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.
Mixed VF and sEMG	targeted dysphagia training maneuver	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.
VF with anodal tDCS	targeted dysphagia training maneuver	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.
VF with anodal tDCS	Videofluoroscopy (VF) and Barium	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.
Videofluoroscopy (VF) and Barium	Biofeedback	This group will receive the following types of procedures during visits. Videofluoroscopy (VF) and Barium to provide biofeedback for targeted dysphagia swallowing maneuver.
Surface Electromyography (sEMG)	Biofeedback	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.
Surface Electromyography (sEMG)	targeted dysphagia training maneuver	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.
Mixed VF and sEMG	Biofeedback	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.
VF with anodal tDCS	Transcranial Direct Current Stimulation	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.
Videofluoroscopy (VF) and Barium	targeted dysphagia training maneuver	This group will receive the following types of procedures during visits. Videofluoroscopy (VF) and Barium to provide biofeedback for targeted dysphagia swallowing maneuver.
Surface Electromyography (sEMG)	Submental Electromyography	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.
VF with anodal tDCS	Transcranial Magnetic Stimulation	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.
Mixed VF, sEMG with anodal tDCS	Biofeedback	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.
Mixed VF, sEMG with anodal tDCS	targeted dysphagia training maneuver	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.
Mixed VF, sEMG with anodal tDCS	Transcranial Magnetic Stimulation	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.
sEMG with sham tDCS	targeted dysphagia training maneuver	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.
Mixed VF and sEMG	Submental Electromyography	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.
sEMG with anodal tDCS	Transcranial Magnetic Stimulation	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.
Mixed VF, sEMG with anodal tDCS	Videofluoroscopy (VF) and Barium	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.
VF with sham tDCS	Transcranial Magnetic Stimulation	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.
Mixed VF, sEMG with sham tDCS	Videofluoroscopy (VF) and Barium	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.
VF with reward	Financial 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.
VF with reward	Videofluoroscopy (VF) and Barium	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.
VF with anodal tDCS	Biofeedback	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.
sEMG with anodal tDCS	Biofeedback	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.
sEMG with anodal tDCS	Transcranial Direct Current Stimulation	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.
sEMG with anodal tDCS	Submental Electromyography	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.
Mixed VF, sEMG with anodal tDCS	Transcranial Direct Current Stimulation	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.
Mixed VF, sEMG with anodal tDCS	Submental Electromyography	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.
VF with sham tDCS	Transcranial Direct Current Stimulation	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.
sEMG with anodal tDCS	targeted dysphagia training maneuver	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.
VF with sham tDCS	Biofeedback	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.
sEMG with sham tDCS	Transcranial Magnetic Stimulation	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.
Mixed VF, sEMG with sham tDCS	targeted dysphagia training maneuver	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.
VF with reward	Biofeedback	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.
sEMG with financial reward	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.
Mixed VF, sEMG with financial reward	Videofluoroscopy (VF) and Barium	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.
VF with sham tDCS	targeted dysphagia training maneuver	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.
VF with sham tDCS	Videofluoroscopy (VF) and Barium	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.
sEMG with sham tDCS	Transcranial Direct Current Stimulation	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.
Mixed VF, sEMG with sham tDCS	Biofeedback	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.
Mixed VF, sEMG with sham tDCS	Transcranial Direct Current Stimulation	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.
Mixed VF, sEMG with sham tDCS	Transcranial Magnetic Stimulation	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.
sEMG with sham tDCS	Biofeedback	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.
sEMG with sham tDCS	Submental Electromyography	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.
Mixed VF, sEMG with financial reward	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.
Mixed VF, sEMG with financial reward	targeted dysphagia training maneuver	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.
Mixed VF, sEMG with financial reward	Submental Electromyography	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.
Mixed VF, sEMG with sham tDCS	Submental Electromyography	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.
VF with reward	targeted dysphagia training maneuver	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.
sEMG with financial reward	targeted dysphagia training maneuver	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.
sEMG with financial reward	Submental Electromyography	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.
sEMG with financial reward	Biofeedback	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.
Mixed VF, sEMG with financial reward	Biofeedback	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.

Primary Outcome Measures

Name	Time	Method
8-Point Penetration-Aspiration scale (P-A scale) will be used to swallowing ability	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.
Targeted dysphagia training biofeedback using VF images will be used to determine the changes from 24 hours, 1 week, and 1 month	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.
Targeted dysphagia training biofeedback using sEMG measures will be used to determine the changes from 24 hours, 1 week and 1 month	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).
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	Changes from 24 hours, 1 week, and 1 month	The mixed biofeedback training will be recorded with sEMG for comparison with VF data.

Secondary Outcome Measures

Name	Time	Method
Training bolus targeted dysphagia maneuvers changes from 24 hours, 1 week, and 1 month	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.
Kinematic analysis will be performed on targeted dysphagia maneuver changes from 24 hours, 1 week, and 1 month.	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.
Training effect on financial reward analysis between 3 groups	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).

Trial Locations

Locations (1): University of Florida Dental Tower Room 130 (DG130)
🇺🇸
Gainesville, Florida, United States

Motor Learning in Dysphagia Rehabilitation

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