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Motor Imagery Exercise and Tongue Strength

Primary Purpose

Dysphagia

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Jaw Exercise with Relaxation
Active Tongue Exercise
Active Tongue Exercise + Mental Practice
Mental Practice Tongue Exercise
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysphagia

Eligibility Criteria

60 Years - 89 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adults aged 60-89
  • < 3 on EAT-10 (Eating Assessment Tool-10) (part of health questionnaire)
  • Mean of ≥2.5 on the KVIQ-10 questions (Kinesthetic and Visual Imagery Questionnaire, short version), a screening questionnaire that assesses a person's motor imagery abilities
  • > 24 on MMSE (Mini Mental State Examination), a screening questionnaire that assesses cognitive abilities
  • Availability to complete a consecutive 6-week exercise regimen
  • Access to reliable transportation to and from study site for in-person experimental sessions
  • There are certain conditions that are common to the aging study population we are recruiting which will be acceptable: controlled hypertension and controlled diabetes mellitus

Exclusion Criteria:

  • History of diagnosed dysphagia (swallowing disorder)
  • History of a seizure(s)
  • Current or past problem with pain disorders involving the jaw muscles or joint of the mandible (e.g., TMJ (temporomandibular) disorder or myofacial pain disorder) - these are contraindicated for tongue strengthening exercises
  • Presence of oral piercings/oral apparatus that may interfere with tongue exercises
  • Medical conditions that would affect oral motor performance (e.g., history of acute or degenerative neurological condition, head/neck cancer), as determined by investigator
  • History of a diagnosed dementia or other cognitive impairment
  • Uncontrolled high blood pressure

Sites / Locations

  • Sarah Hegyi Szynkiewicz, PhD, CCC-SLPRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Experimental

Experimental

Arm Label

Active Jaw Exercise with Relaxation

Active Tongue Exercise

Active Tongue Exercise + Mental Practice

Mental Practice Tongue Exercise

Arm Description

Participants randomized to this arm will complete active jaw exercises and visualization relaxation exercise (control group).

Participants randomized to this arm will complete active tongue exercises only.

Participants randomized to this arm will complete active tongue exercises and mental practice of tongue exercise via motor imagery.

Participants randomized to this arm will complete mental practice of tongue exercise via motor imagery only.

Outcomes

Primary Outcome Measures

Tongue strength change
Maximum tongue strength as measured using the Iowa Oral Performance Instrument.

Secondary Outcome Measures

Swallowing pressure change
Regular lingual swallowing pressure as measured using the Iowa Oral Performance Instrument.

Full Information

First Posted
January 15, 2018
Last Updated
April 15, 2019
Sponsor
University of South Florida
Collaborators
James Madison University, Texas Christian University, Loma Linda University
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1. Study Identification

Unique Protocol Identification Number
NCT03423095
Brief Title
Motor Imagery Exercise and Tongue Strength
Official Title
The Effects of a Motor Imagery Exercise Program on Tongue Strength
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 19, 2017 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida
Collaborators
James Madison University, Texas Christian University, Loma Linda University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This research study is a six-week treatment pilot study to compare the effects of different exercise types on measures of tongue strength and swallowing pressure in typically aging older adults. Typically-aging older adults represent a group "at risk" for dysphagia secondary to sarcopenia of striated musculature important to swallowing. Participants at all study sites will be randomly selected into one of four study exercise groups. At some study sites, the investigators will also determine cortical activation patterns differences during motor execution and motor imagery of tongue exercises between the groups using near-infrared spectroscopy. The results of this study will inform refinement/further development of the mental practice protocol to use with patients with dysphagia in future studies.
Detailed Description
Although motor imagery (MI) has not yet been researched in the field of swallowing rehabilitation, the potential benefit is far reaching. Difficulty swallowing, or dysphagia, can occur in people who have a history of stroke, head injury, neurological disease (such as Parkinson's disease, ALS, etc.), and head/neck cancer. A person with dysphagia may have difficulty eating everyday foods and may require an altered diet, such as tube feedings or pureed foods. Because of this, having dysphagia is often associated with increased feelings of isolation and depression. Speech-language pathologists work with people with dysphagia to rehabilitate their swallow, with the goal of reducing their risk of choking and improving their ability to eat normal foods. The use of MI as a way to augment dysphagia rehabilitation has implications for patients who aren't safe to have any food by mouth as well as those who fatigue easily. This research study is a six-week treatment pilot study to determine the effect of motor imagery for tongue strengthening exercises on measures of tongue strength and swallowing pressure in typically aging older adults. Typically-aging older adults represent a group "at risk" for dysphagia secondary to sarcopenia of striated musculature important to swallowing. Participants at all study sites will be randomly selected into one of four groups: 1) placebo (active jaw open against resistance/close against resistance/lateralize/protrusion exercises with relaxation exercises), 2) active tongue exercises against resistance only, 3) active tongue exercises against resistance + motor imagery of tongue exercises against resistance, and 4) motor imagery of tongue exercises against resistance only. In some participants the investigators will also determine cortical activation patterns differences during motor execution and motor imagery of tongue exercises between the groups using near-infrared spectroscopy. The results of this study will inform refinement/further development of the mental practice protocol to use with patients with dysphagia in future studies. The research questions are as follows: Does a 6 week treatment of motor imagery tongue exercises with or without active tongue exercise improve tongue strength in healthy older adults compared to a 6 week treatment of placebo exercises and 6 week treatment of active tongue strengthening exercises? Does a 6 week treatment of motor imagery tongue exercises with or without active tongue exercise improve swallowing pressures in healthy older adults compared to a 6 week treatment of placebo exercises and 6 week treatment of active tongue strengthening exercises? Does a 6 week treatment of motor imagery tongue exercises with or without active tongue exercise alter cortical hemodynamic response patterns in healthy older adults compared to a 6 week treatment of placebo exercises and 6 week treatment of active tongue strengthening exercises? (JMU participants only). The investigators hypothesize, based on previous research, that the group receiving both active and MI treatment will make the most gains in all three measures, followed by the active only group, then the MI only group, then the placebo group (control).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Jaw Exercise with Relaxation
Arm Type
Placebo Comparator
Arm Description
Participants randomized to this arm will complete active jaw exercises and visualization relaxation exercise (control group).
Arm Title
Active Tongue Exercise
Arm Type
Active Comparator
Arm Description
Participants randomized to this arm will complete active tongue exercises only.
Arm Title
Active Tongue Exercise + Mental Practice
Arm Type
Experimental
Arm Description
Participants randomized to this arm will complete active tongue exercises and mental practice of tongue exercise via motor imagery.
Arm Title
Mental Practice Tongue Exercise
Arm Type
Experimental
Arm Description
Participants randomized to this arm will complete mental practice of tongue exercise via motor imagery only.
Intervention Type
Behavioral
Intervention Name(s)
Active Jaw Exercise with Relaxation
Intervention Description
This is the control group that will complete exercises unrelated to the primary outcome measures.
Intervention Type
Behavioral
Intervention Name(s)
Active Tongue Exercise
Intervention Description
This is the active comparator group that will complete exercises already shown to increase tongue strength measures.
Intervention Type
Behavioral
Intervention Name(s)
Active Tongue Exercise + Mental Practice
Intervention Description
This is an experimental group that will complete active tongue and mental tongue exercises to assess effect on tongue strength measures.
Intervention Type
Behavioral
Intervention Name(s)
Mental Practice Tongue Exercise
Intervention Description
This is an experimental group that will complete mental tongue exercises only to assess effect on tongue strength measures.
Primary Outcome Measure Information:
Title
Tongue strength change
Description
Maximum tongue strength as measured using the Iowa Oral Performance Instrument.
Time Frame
Change from baseline tongue strength at 6 weeks
Secondary Outcome Measure Information:
Title
Swallowing pressure change
Description
Regular lingual swallowing pressure as measured using the Iowa Oral Performance Instrument.
Time Frame
Change from baseline swallowing pressure strength at 6 weeks
Other Pre-specified Outcome Measures:
Title
Cortical activation pattern change
Description
Patterns relative changes of oxygenation during motor execution and motor imagery of tongue movements will be measured in some participants at the James Madison University study site using near-infrared spectroscopy.
Time Frame
Change from baseline tongue relative percent change in oxygenation at 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adults aged 60-89 < 3 on EAT-10 (Eating Assessment Tool-10) (part of health questionnaire) Mean of ≥2.5 on the KVIQ-10 questions (Kinesthetic and Visual Imagery Questionnaire, short version), a screening questionnaire that assesses a person's motor imagery abilities > 24 on MMSE (Mini Mental State Examination), a screening questionnaire that assesses cognitive abilities Availability to complete a consecutive 6-week exercise regimen Access to reliable transportation to and from study site for in-person experimental sessions There are certain conditions that are common to the aging study population we are recruiting which will be acceptable: controlled hypertension and controlled diabetes mellitus Exclusion Criteria: History of diagnosed dysphagia (swallowing disorder) History of a seizure(s) Current or past problem with pain disorders involving the jaw muscles or joint of the mandible (e.g., TMJ (temporomandibular) disorder or myofacial pain disorder) - these are contraindicated for tongue strengthening exercises Presence of oral piercings/oral apparatus that may interfere with tongue exercises Medical conditions that would affect oral motor performance (e.g., history of acute or degenerative neurological condition, head/neck cancer), as determined by investigator History of a diagnosed dementia or other cognitive impairment Uncontrolled high blood pressure
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Hegyi Szynkiewicz, PhD
Phone
941-359-4383
Email
sehegyi@usf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Hegyi Szynkiewicz, PhD
Organizational Affiliation
USF Sarasota-Manatee
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sarah Hegyi Szynkiewicz, PhD, CCC-SLP
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34243
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Hegyi Szynkiewicz, PhD
Phone
941-359-4383
Email
sehegyi@usf.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The privacy and confidentiality of the participants will be maintained. Each participant's identity will be disassociated from the participant's personal data - a subject number will be assigned to each participant upon signing of the informed consent. De-identified data will be shared between universities using a secure and password protected account.
IPD Sharing Time Frame
De-identified data will be shared from the beginning of enrollment between universities using a password secure Box account and only de-identified data will be kept after the project ends.
IPD Sharing Access Criteria
De-identified data will be shared from the beginning of enrollment between universities using a password secure Box account to which all investigators have access.

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Motor Imagery Exercise and Tongue Strength

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