DysphagiaNCT03423095
Motor Imagery Exercise and Tongue Strength
A study testing Active Jaw Exercise with Relaxation, Active Tongue Exercise and Active Tongue Exercise + Mental Practice in people with Dysphagia, run by University of South Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Dysphagia
- What is being tested?
- Active Jaw Exercise with Relaxation, Active Tongue Exercise and Active Tongue Exercise + Mental Practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2017to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Sarah Hegyi Szynkiewicz, PhD, CCC-SLP
Sarasota, Florida, 34243
Sarah Hegyi Szynkiewicz, PhD, 941-359-4383, sehegyi@usf.edu
About this study
Official title: The Effects of a Motor Imagery Exercise Program on Tongue Strength
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.
Read the 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).
- Conditions
- Dysphagia
- Being tested
- Active Jaw Exercise with Relaxation, Active Tongue Exercise, Active Tongue Exercise + Mental Practice, Mental Practice Tongue Exercise
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Jaw Exercise with RelaxationBehavioural
This is the control group that will complete exercises unrelated to the primary outcome measures.
Active Tongue ExerciseBehavioural
This is the active comparator group that will complete exercises already shown to increase tongue strength measures.
Active Tongue Exercise + Mental PracticeBehavioural
This is an experimental group that will complete active tongue and mental tongue exercises to assess effect on tongue strength measures.
Mental Practice Tongue ExerciseBehavioural
This is an experimental group that will complete mental tongue exercises only to assess effect on tongue strength measures.
| Study group | Role | What they receive |
|---|---|---|
| Active Jaw Exercise with Relaxation | Placebo comparator | Participants randomized to this arm will complete active jaw exercises and visualization relaxation exercise (control group). Receives: Behavioral: Active Jaw Exercise with Relaxation |
| Active Tongue Exercise | Active comparator | Participants randomized to this arm will complete active tongue exercises only. Receives: Behavioral: Active Tongue Exercise |
| Active Tongue Exercise + Mental Practice | Experimental | Participants randomized to this arm will complete active tongue exercises and mental practice of tongue exercise via motor imagery. Receives: Behavioral: Active Tongue Exercise + Mental Practice |
| Mental Practice Tongue Exercise | Experimental | Participants randomized to this arm will complete mental practice of tongue exercise via motor imagery only. Receives: Behavioral: Mental Practice Tongue Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tongue strength change
Maximum tongue strength as measured using the Iowa Oral Performance Instrument.
Measured: Change from baseline tongue strength at 6 weeks
Secondary outcomes (1)
Swallowing pressure change
Regular lingual swallowing pressure as measured using the Iowa Oral Performance Instrument.
Measured: Change from baseline swallowing pressure strength at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start19 Dec 2017
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- James Madison University, Texas Christian University, Loma Linda University
- Responsible party
- Sponsor
- Investigators
- Sarah Hegyi Szynkiewicz, PhD, Principal investigator, USF Sarasota-Manatee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03423095
- Sponsor's protocol ID
- Pro00033331
- Status last verified
- Oct 2018
- First submitted
- 15 Jan 2018
- Last updated
- 17 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Motor Imagery Exercise Program on Tongue Strength
- ClinicalTrials.gov ID
- NCT03423095
- Acronym / sponsor ID
- Pro00033331
- Conditions
- Dysphagia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- James Madison University, Texas Christian University, Loma Linda University
- Study start
- 19 Dec 2017 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 6 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active Jaw Exercise with Relaxation | Placebo comparator | Behavioral: Active Jaw Exercise with RelaxationParticipants randomized to this arm will complete active jaw exercises and visualization relaxation exercise (control group). |
| Active Tongue Exercise | Active comparator | Behavioral: Active Tongue ExerciseParticipants randomized to this arm will complete active tongue exercises only. |
| Active Tongue Exercise + Mental Practice | Experimental | Behavioral: Active Tongue Exercise + Mental PracticeParticipants randomized to this arm will complete active tongue exercises and mental practice of tongue exercise via motor imagery. |
| Mental Practice Tongue Exercise | Experimental | Behavioral: Mental Practice Tongue ExerciseParticipants randomized to this arm will complete mental practice of tongue exercise via motor imagery only. |
Who may qualify
- Ages
- 60 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Jaw Exercise with RelaxationThis is the control group that will complete exercises unrelated to the primary outcome measures. | Behavioural | Active Jaw Exercise with Relaxation |
| Active Tongue ExerciseThis is the active comparator group that will complete exercises already shown to increase tongue strength measures. | Behavioural | Active Tongue Exercise |
| Active Tongue Exercise + Mental PracticeThis is an experimental group that will complete active tongue and mental tongue exercises to assess effect on tongue strength measures. | Behavioural | Active Tongue Exercise + Mental Practice |
| Mental Practice Tongue ExerciseThis is an experimental group that will complete mental tongue exercises only to assess effect on tongue strength measures. | Behavioural | Mental Practice Tongue Exercise |
Primary outcome
Tongue strength change
Time frame: Change from baseline tongue strength at 6 weeks
Maximum tongue strength as measured using the Iowa Oral Performance Instrument.
1 secondary outcome
Swallowing pressure change
Time frame: Change from baseline swallowing pressure strength at 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Hegyi Szynkiewicz, PhD principal investigator
USF Sarasota-Manatee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Jaw Exercise with Relaxation, Active Tongue Exercise and Active Tongue Exercise + Mental Practice in people with Dysphagia, run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah Hegyi Szynkiewicz, PhD (941-359-4383, sehegyi@usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tongue strength change (time frame: Change from baseline tongue strength at 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019; AzTrials last refreshed its copy on 3 Nov 2026.