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| ID | Type | Description | Link |
|---|---|---|---|
| R03DC004942 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
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The primary goal of the investigation is to determine the effects of the Mendelsohn maneuver on the physiology of the swallow in individuals who have suffered a stroke and exhibit signs of pharyngeal dysphagia.
The primary goal of the investigation is to determine the effects of the Mendelsohn maneuver (voluntary prolongation of laryngeal excursion at the midpoint of the swallow) on the physiology of the swallow in individuals who have suffered a stroke and exhibit signs of pharyngeal dysphagia (specifically, reduced duration of hyoid maximum elevation, reduced extent of hyoid maximum elevation, reduced duration of hyoid maximum anterior excursion, reduced extent of hyoid maximum anterior excursion, and reduced duration of upper esophageal sphincter (UES) opening with subsequent residue in the pyriform sinuses and, potentially, aspiration). Participants are assessed with videofluoroscopy at the initiation of the study and after each week of the study. After the 4 weeks of participation are complete, all participants will be discharged from treatment and will be brought back to the clinic for a final Videofluoroscopic Swallow Study (VFSS) evaluation after 2 weeks. This means that individuals in Group 1 will be re-analyzed after 1 month of additional no-treatment, and Group 2 will be re-analyzed after 2 additional weeks of no-treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Within subjects treatment, no-treatment | Experimental | Within subject, treatment and no-treatment periods. Each participant served as his/her own control in this AABB/BBAA alternating treatment conditions design. Results were also compared across groups (treatment v. no-treatment). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mendelsohn Maneuver | Behavioral | Mendelsohn Maneuver with Surface Electromyography |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Duration of Superior Hyolaryngeal Movement | Change in duration of superior elevation of hyoid bone. | baseline and six weeks |
| Change in Duration of Hyoid Maximum Anterior Excursion | Change in the duration of maximum anterior movement of the hyoid bone during swallowing. | Baseline and 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Oral Intake Ability | Oral Intake Ability was measure with the Dysphagia Outcome and Severity Scale. A 7 is normal and a 1 is complete inability to consume any food safely. The means reported for treatment and no treatment periods are mean changes in scores throughout the period. | Baseline and 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gary H McCullough, Ph.D. | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UArkansas/UAMS Medical Center | Little Rock | Arkansas | 72035 | United States |
Participants were only assigned to a group after their initial evaluation and no exclusions were necessary. Participants were each assigned to receive 2 weeks of treatment and two weeks of no treatment. Assignments were randomized so half began with treatment and half began with no treatment.
Recruitment of participants occurred through The University of Arkansas for Medical Sciences Medical Center Speech Pathology Clinic and newspaper advertisements between February 2003 and February 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | No Treatment Then Treatment | Participants received 2 weeks of no-treatment and then 2 weeks of treatment with the Mendelsohn manuever. |
| FG001 | Treatment Then No Treatment | Participants received 2 weeks of treatment with the Mendelsohn manuever and then 2 weeks of no treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (2 Weeks) |
| |||||||||||||
| Second Intervention (2 Weeks) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | This includes all participants. Half received treatment then no treatment and have received no treatment then treatment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Participants were analyzed for age effects within analysis of variance. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Duration of Superior Hyolaryngeal Movement | Change in duration of superior elevation of hyoid bone. | per protocol | Posted | Apr 2010 | Mean | Standard Deviation | seconds | baseline and six weeks |
|
Subjects were followed for up to one year after study completion.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Treatment Then Treatment | Participants received 2 weeks of no-treatment and then 2 weeks of treatment with the Mendelsohn manuever. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gary McCullough | UAMS Medical Center | 501-852-7886 | mcculloughgaryh@uams.edu |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Change in Duration of Opening of Upper Esophageal Sphincter |
Change in duration of pre- and post-treatment duration of UES opening. |
| Baseline and 6 weeks |
| NOT COMPLETED |
|
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Gender effects were analyzed within the analysis of variance. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Change in Oral Intake Ability | Oral Intake Ability was measure with the Dysphagia Outcome and Severity Scale. A 7 is normal and a 1 is complete inability to consume any food safely. The means reported for treatment and no treatment periods are mean changes in scores throughout the period. | Posted | Jan 2010 | Mean | Standard Deviation | units on a scale | Baseline and 6 weeks |
|
|
|
| Secondary | Change in Duration of Opening of Upper Esophageal Sphincter | Change in duration of pre- and post-treatment duration of UES opening. | Posted | Jan 2010 | Mean | Standard Deviation | seconds | Baseline and 6 weeks |
|
|
|
| Primary | Change in Duration of Hyoid Maximum Anterior Excursion | Change in the duration of maximum anterior movement of the hyoid bone during swallowing. | Posted | Apr 2010 | Mean | Standard Deviation | seconds | Baseline and 6 weeks |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Treatment Then No Treatment | Participants received 2 weeks of treatment with the Mendelsohn manuever and then 2 weeks of no treatment. | 0 | 18 | 0 | 18 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |