Clinical trial NCT02576470: Motor Learning in Dysphagia Rehabilitation
Official title: Applying Motor Learning Principles to Dysphagia Rehabilitation R01DC014285
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dysphagia
Swallowing Disorders
Deglutition Disorders
Stroke
Keywords: swallowing
stroke
dysphagia
deglutition
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: American Heart Association
name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2015-10-15
Enrollment: 74
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* swallowing problem

Exclusion Criteria:

* pregnant
* allergy to barium
* moderate to severe dementia
* serious respiratory illness

Primary outcomes:
measure: 8-Point Penetration-Aspiration scale (P-A scale) will be used to swallowing ability
timeFrame: Changes from 24 hrs, 1 week, 1 month
measure: Targeted dysphagia training biofeedback using VF images will be used to determine the changes from 24 hours, 1 week, and 1 month
timeFrame: Changes from 24 hours, 1 week, and 1 month
measure: Targeted dysphagia training biofeedback using sEMG measures will be used to determine the changes from 24 hours, 1 week and 1 month
timeFrame: Changes from 24 hours, 1 week, and 1 month
measure: 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
timeFrame: Changes from 24 hours, 1 week, and 1 month
Secondary outcomes:
measure: Training bolus targeted dysphagia maneuvers changes from 24 hours, 1 week, and 1 month
timeFrame: Changes from 24 hours, 1 week, and 1 month
measure: Kinematic analysis will be performed on targeted dysphagia maneuver changes from 24 hours, 1 week, and 1 month.
timeFrame: Changes from 24 hours, 1 week, and 1 month
measure: Training effect on financial reward analysis between 3 groups
timeFrame: Changes from days 1, 2, and 3
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida Dental Tower Room 130 (DG130)
state: Florida
Study officials:
affiliation: University of Florida
name: Inaessa A Humbert, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Susan Nittrouer, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.