Dysphagia, Stroke
Conditions
Keywords
Deglutition Disorders, Mendelsohn Maneuver, SEMG
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALMendelsohn Maneuver
Mendelsohn Maneuver with Surface Electromyography
Sponsors
National Institute on Deafness and Other Communication Disorders (NIDCD)
University of Arkansas
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Stroke (1-18 months post) * Pharyngeal Dysphagia
Exclusion criteria
* Other neurologic or structural abnormality to oropharynx * History of dysphagia prior to latest stroke
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Duration of Superior Hyolaryngeal Movement | baseline and six weeks | Change in duration of superior elevation of hyoid bone. |
| Change in Duration of Hyoid Maximum Anterior Excursion | Baseline and 6 weeks | Change in the duration of maximum anterior movement of the hyoid bone during swallowing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Oral Intake Ability | Baseline and 6 weeks | 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. |
| Change in Duration of Opening of Upper Esophageal Sphincter | Baseline and 6 weeks | Change in duration of pre- and post-treatment duration of UES opening. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population This includes all participants. Half received treatment then no treatment and have received no treatment then treatment. | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 11 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 18 | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 |
Outcome results
Primary
Change in Duration of Hyoid Maximum Anterior Excursion
Change in the duration of maximum anterior movement of the hyoid bone during swallowing.
Time frame: Baseline and 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Treatment Then Treatment | Change in Duration of Hyoid Maximum Anterior Excursion | .233 seconds | Standard Deviation 0.157 |
| Treatment Then No Treatment | Change in Duration of Hyoid Maximum Anterior Excursion | .247 seconds | Standard Deviation 0.161 |
Primary
Change in Duration of Superior Hyolaryngeal Movement
Change in duration of superior elevation of hyoid bone.
Time frame: baseline and six weeks
Population: per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Treatment Then Treatment | Change in Duration of Superior Hyolaryngeal Movement | .213 seconds | Standard Deviation 0.154 |
| Treatment Then No Treatment | Change in Duration of Superior Hyolaryngeal Movement | .233 seconds | Standard Deviation 0.184 |
Secondary
Change in Duration of Opening of Upper Esophageal Sphincter
Change in duration of pre- and post-treatment duration of UES opening.
Time frame: Baseline and 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Treatment Then Treatment | Change in Duration of Opening of Upper Esophageal Sphincter | .584 seconds | Standard Deviation 0.159 |
| Treatment Then No Treatment | Change in Duration of Opening of Upper Esophageal Sphincter | .610 seconds | Standard Deviation 0.183 |
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.
Time frame: Baseline and 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Treatment Then Treatment | Change in Oral Intake Ability | 1.8 units on a scale | Standard Deviation 0.15 |
| Treatment Then No Treatment | Change in Oral Intake Ability | 2.3 units on a scale | Standard Deviation 0.11 |