Motor Imagery Exercise and Tongue Strength

NCT ID: NCT03423095

Last Updated: 2019-04-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-19
• Study Completion Date: 2019-12-31

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:

1. 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?

2. 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?

3. 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).

Conditions

Dysphagia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active Jaw Exercise with Relaxation

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

Group Type: PLACEBO_COMPARATOR

Active Jaw Exercise with Relaxation

Intervention Type: BEHAVIORAL

This is the control group that will complete exercises unrelated to the primary outcome measures.

Active Tongue Exercise

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

Group Type: ACTIVE_COMPARATOR

Active Tongue Exercise

Intervention Type: BEHAVIORAL

This is the active comparator group that will complete exercises already shown to increase tongue strength measures.

Active Tongue Exercise + Mental Practice

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

Group Type: EXPERIMENTAL

Active Tongue Exercise + Mental Practice

Intervention Type: BEHAVIORAL

This is an experimental group that will complete active tongue and mental tongue exercises to assess effect on tongue strength measures.

Mental Practice Tongue Exercise

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

Group Type: EXPERIMENTAL

Mental Practice Tongue Exercise

Intervention Type: BEHAVIORAL

This is an experimental group that will complete mental tongue exercises only to assess effect on tongue strength measures.

Interventions

Active Jaw Exercise with Relaxation

This is the control group that will complete exercises unrelated to the primary outcome measures.

Intervention Type: BEHAVIORAL

Active Tongue Exercise

This is the active comparator group that will complete exercises already shown to increase tongue strength measures.

Intervention Type: BEHAVIORAL

Active Tongue Exercise + Mental Practice

This is an experimental group that will complete active tongue and mental tongue exercises to assess effect on tongue strength measures.

Intervention Type: BEHAVIORAL

Mental Practice Tongue Exercise

This is an experimental group that will complete mental tongue exercises only to assess effect on tongue strength measures.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

James Madison University

OTHER

Sponsor Role: collaborator

Texas Christian University

OTHER

Sponsor Role: collaborator

Loma Linda University

OTHER

Sponsor Role: collaborator

University of South Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah Hegyi Szynkiewicz, PhD

Role: PRINCIPAL_INVESTIGATOR

USF Sarasota-Manatee

Locations

Sarah Hegyi Szynkiewicz, PhD, CCC-SLP

Sarasota, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sarah Hegyi Szynkiewicz, PhD

Role: CONTACT

sehegyi@usf.edu

941-359-4383

Facility Contacts

Sarah Hegyi Szynkiewicz, PhD

Role: primary

sehegyi@usf.edu

941-359-4383

Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Pro00033331

Identifier Type: -

Identifier Source: org_study_id