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| Name | Class |
|---|---|
| James Madison University | OTHER |
| Texas Christian University | OTHER |
| Loma Linda University | OTHER |
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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.
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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Jaw Exercise with Relaxation | Placebo Comparator | Participants randomized to this arm will complete active jaw exercises and visualization relaxation exercise (control group). |
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| Active Tongue Exercise | Active Comparator | Participants randomized to this arm will complete active tongue exercises only. |
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| 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. |
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| Mental Practice Tongue Exercise | Experimental | Participants randomized to this arm will complete mental practice of tongue exercise via motor imagery only. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Jaw Exercise with Relaxation | Behavioral | This is the control group that will complete exercises unrelated to the primary outcome measures. |
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| Measure | Description | Time Frame |
|---|---|---|
| Tongue strength change | Maximum tongue strength as measured using the Iowa Oral Performance Instrument. | Change from baseline tongue strength at 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Swallowing pressure change | Regular lingual swallowing pressure as measured using the Iowa Oral Performance Instrument. | Change from baseline swallowing pressure strength at 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cortical activation pattern change | 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. | Change from baseline tongue relative percent change in oxygenation at 6 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Hegyi Szynkiewicz, PhD | Contact | 941-359-4383 | sehegyi@usf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sarah Hegyi Szynkiewicz, PhD | USF Sarasota-Manatee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sarah Hegyi Szynkiewicz, PhD, CCC-SLP | Recruiting | Sarasota | Florida | 34243 | United States |
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.
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.
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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 1, 2018 | Apr 15, 2019 | ICF_003.pdf |
| Prot | Yes | No | No | Study Protocol | Sep 4, 2018 | Apr 15, 2019 | Prot_004.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 30, 2019 | Apr 15, 2019 | SAP_005.pdf |
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| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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| Active Tongue Exercise | Behavioral | This is the active comparator group that will complete exercises already shown to increase tongue strength measures. |
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| Active Tongue Exercise + Mental Practice | Behavioral | This is an experimental group that will complete active tongue and mental tongue exercises to assess effect on tongue strength measures. |
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| Mental Practice Tongue Exercise | Behavioral | This is an experimental group that will complete mental tongue exercises only to assess effect on tongue strength measures. |
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| D010038 | Otorhinolaryngologic Diseases |