Motor Learning in Dysphagia Rehabilitation

Not Applicable

Terminated

• Conditions: Swallowing Disorders; Deglutition Disorders; Stroke; Dysphagia

• 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.

Study Timeline

• Study First Submitted: 2015-10-12
• Study First Submitted QC: 2015-10-13
• Study First Posted: 2015-10-15
• Study Start: 2015-11
• Primary Completion: 2019-09-19
• Study Completion: 2019-09-19
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-02
• Last Update Posted: 2019-10-04

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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