Trial Outcomes & Findings for Lingual Endurance Exercise in Treating Post-Stroke Dysphagia (NCT NCT05523973)
NCT ID: NCT05523973
Last Updated: 2025-05-07
Results Overview
% \[(total number of days of attempted exercise/total number of days prescribed over 8 weeks of therapy)x100\]
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
Assessed at 8 weeks (study completion)
Results posted on
2025-05-07
Participant Flow
Participant milestones
| Measure |
Lingual Endurance Training
Participants will complete lingual endurance training 2-3 times a day. Half of the participants will also complete a session of effortful swallows with the device.
Lingual Endurance Training: Participants will participate in 3 training sessions per day for 8 weeks. Some participants will complete 3 sessions of lingual endurance exercise. For example, if the participant completed 100 repetitions during the baseline measurement, they would complete 75 repetitions during their exercise session. Other participants will complete effortful swallows during their 3rd training session. These participants will complete 30 swallows where they are instructed to press their tongue hard on the bulb and swallow their saliva.
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|---|---|
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Overall Study
STARTED
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19
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Overall Study
COMPLETED
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15
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Overall Study
NOT COMPLETED
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4
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lingual Endurance Exercise in Treating Post-Stroke Dysphagia
Baseline characteristics by cohort
| Measure |
Lingual Endurance Training
n=19 Participants
Intervention group will complete lingual endurance training. Half of the participants also completed effortful swallows once per day
Lingual Endurance Exercise: Participants will participate in 3 training sessions per day for 8 weeks. Half of the participants completed 3 sessions of lingual endurance exercise. For example, if the participant completed 100 repetitions during the baseline measurement, they would complete 75 repetitions during their exercise session. The other half completed 2 of these sessions, with 1 session of effortful swallow practice (10 repetitions)
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Age, Continuous
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66 years
STANDARD_DEVIATION 13.6 • n=93 Participants
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Sex: Female, Male
Female
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6 Participants
n=93 Participants
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Sex: Female, Male
Male
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13 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=93 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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19 Participants
n=93 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=93 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Black or African American
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4 Participants
n=93 Participants
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Race (NIH/OMB)
White
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15 Participants
n=93 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=93 Participants
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Region of Enrollment
United States
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19 participants
n=93 Participants
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PRIMARY outcome
Timeframe: Assessed at 8 weeks (study completion)Population: Only participants that completed baseline and final visits
% \[(total number of days of attempted exercise/total number of days prescribed over 8 weeks of therapy)x100\]
Outcome measures
| Measure |
Lingual Endurance Training
n=15 Participants
Participants will complete lingual endurance training 2-3 times a day. Half of the participants will also complete a session of effortful swallows with the device.
Lingual Endurance Training: Participants will participate in 3 training sessions per day for 8 weeks. Some participants will complete 3 sessions of lingual endurance exercise. For example, if the participant completed 100 repetitions during the baseline measurement, they would complete 75 repetitions during their exercise session. Other participants will complete effortful swallows during their 3rd training session. These participants will complete 30 swallows where they are instructed to press their tongue hard on the bulb and swallow their saliva.
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|---|---|
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Adherence
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79 percentage of adherence
Standard Deviation 29
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PRIMARY outcome
Timeframe: Baseline and 8 WeeksImprovement on Oral Total (OT) score MBSImP; OT score minimum score (best) =0; OT maximum score (worst) = 22
Outcome measures
| Measure |
Lingual Endurance Training
n=15 Participants
Participants will complete lingual endurance training 2-3 times a day. Half of the participants will also complete a session of effortful swallows with the device.
Lingual Endurance Training: Participants will participate in 3 training sessions per day for 8 weeks. Some participants will complete 3 sessions of lingual endurance exercise. For example, if the participant completed 100 repetitions during the baseline measurement, they would complete 75 repetitions during their exercise session. Other participants will complete effortful swallows during their 3rd training session. These participants will complete 30 swallows where they are instructed to press their tongue hard on the bulb and swallow their saliva.
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|---|---|
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Change From Baseline Modified Barium Swallowing Impairment Profile (MBSImP) Oral Total Score
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0.2667 score on a scale
Standard Deviation 2.82
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SECONDARY outcome
Timeframe: Baseline and 8 Weeksmeasure of airway invasion during swallowing, best score = 1, worst score = 8 Number of patients who improved worst PAS score from baseline to 8 week timepoint
Outcome measures
| Measure |
Lingual Endurance Training
n=15 Participants
Participants will complete lingual endurance training 2-3 times a day. Half of the participants will also complete a session of effortful swallows with the device.
Lingual Endurance Training: Participants will participate in 3 training sessions per day for 8 weeks. Some participants will complete 3 sessions of lingual endurance exercise. For example, if the participant completed 100 repetitions during the baseline measurement, they would complete 75 repetitions during their exercise session. Other participants will complete effortful swallows during their 3rd training session. These participants will complete 30 swallows where they are instructed to press their tongue hard on the bulb and swallow their saliva.
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|---|---|
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Participant Improving Worst Penetration Aspiration Scale (PAS) Score
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6 Participants
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SECONDARY outcome
Timeframe: Baseline and 8 WeeksAnalysis of Swallowing Physiology, Kinematics, Events, Timing (ASPEKT): The ASPEKT method uses ImageJ pixel based measures of post-swallow residue (Total% of C2-C4)
Outcome measures
| Measure |
Lingual Endurance Training
n=15 Participants
Participants will complete lingual endurance training 2-3 times a day. Half of the participants will also complete a session of effortful swallows with the device.
Lingual Endurance Training: Participants will participate in 3 training sessions per day for 8 weeks. Some participants will complete 3 sessions of lingual endurance exercise. For example, if the participant completed 100 repetitions during the baseline measurement, they would complete 75 repetitions during their exercise session. Other participants will complete effortful swallows during their 3rd training session. These participants will complete 30 swallows where they are instructed to press their tongue hard on the bulb and swallow their saliva.
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Change From Baseline in Post-swallow Residue (Solid)
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-1.33 percent of C2-C4
Standard Deviation 2.5
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SECONDARY outcome
Timeframe: Baseline and 8 WeeksAnalysis of Swallowing Physiology, Kinematics, Events, Timing (ASPEKT): The ASPEKT method uses ImageJ pixel based measures of post-swallow residue (Total% of C2-C4)
Outcome measures
| Measure |
Lingual Endurance Training
n=15 Participants
Participants will complete lingual endurance training 2-3 times a day. Half of the participants will also complete a session of effortful swallows with the device.
Lingual Endurance Training: Participants will participate in 3 training sessions per day for 8 weeks. Some participants will complete 3 sessions of lingual endurance exercise. For example, if the participant completed 100 repetitions during the baseline measurement, they would complete 75 repetitions during their exercise session. Other participants will complete effortful swallows during their 3rd training session. These participants will complete 30 swallows where they are instructed to press their tongue hard on the bulb and swallow their saliva.
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|---|---|
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Change From Baseline in Post-swallow Residue (Puree)
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-.67 percent of C2-C4
Standard Deviation 6.6
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SECONDARY outcome
Timeframe: Baseline and 8 WeeksAnalysis of Swallowing Physiology, Kinematics, Events, Timing (ASPEKT): The ASPEKT method uses ImageJ pixel based measures of post-swallow residue (Total% of C2-C4)
Outcome measures
| Measure |
Lingual Endurance Training
n=10 Participants
Participants will complete lingual endurance training 2-3 times a day. Half of the participants will also complete a session of effortful swallows with the device.
Lingual Endurance Training: Participants will participate in 3 training sessions per day for 8 weeks. Some participants will complete 3 sessions of lingual endurance exercise. For example, if the participant completed 100 repetitions during the baseline measurement, they would complete 75 repetitions during their exercise session. Other participants will complete effortful swallows during their 3rd training session. These participants will complete 30 swallows where they are instructed to press their tongue hard on the bulb and swallow their saliva.
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|---|---|
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Change From Baseline in Post-swallow Residue (Thin Liquids)
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-1.5 percent of C2-C4
Standard Deviation 4.2
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SECONDARY outcome
Timeframe: Baseline and 8 WeeksAnalysis of Swallowing Physiology, Kinematics, Events, Timing (ASPEKT): The ASPEKT method uses ImageJ pixel based measures of post-swallow residue (Total% of C2-C4)
Outcome measures
| Measure |
Lingual Endurance Training
n=11 Participants
Participants will complete lingual endurance training 2-3 times a day. Half of the participants will also complete a session of effortful swallows with the device.
Lingual Endurance Training: Participants will participate in 3 training sessions per day for 8 weeks. Some participants will complete 3 sessions of lingual endurance exercise. For example, if the participant completed 100 repetitions during the baseline measurement, they would complete 75 repetitions during their exercise session. Other participants will complete effortful swallows during their 3rd training session. These participants will complete 30 swallows where they are instructed to press their tongue hard on the bulb and swallow their saliva.
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|---|---|
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Change From Baseline in Post-swallow Residue (Mildly Thick Liquids)
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-1.01 percent of C2-C4
Standard Deviation 2.58
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SECONDARY outcome
Timeframe: Baseline and 8 WeeksAnalysis of Swallowing Physiology, Kinematics, Events, Timing (ASPEKT): The ASPEKT method uses ImageJ pixel based measures of post-swallow residue (Total% of C2-C4)
Outcome measures
| Measure |
Lingual Endurance Training
n=14 Participants
Participants will complete lingual endurance training 2-3 times a day. Half of the participants will also complete a session of effortful swallows with the device.
Lingual Endurance Training: Participants will participate in 3 training sessions per day for 8 weeks. Some participants will complete 3 sessions of lingual endurance exercise. For example, if the participant completed 100 repetitions during the baseline measurement, they would complete 75 repetitions during their exercise session. Other participants will complete effortful swallows during their 3rd training session. These participants will complete 30 swallows where they are instructed to press their tongue hard on the bulb and swallow their saliva.
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Change From Baseline in Post-swallow Residue (Moderately Thick Liquids)
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.25 percent of C2-C4
Standard Deviation 5.0
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SECONDARY outcome
Timeframe: Baseline and 8 WeeksPatient reported outcome measure of swallowing quality of life, 0 = best score; 100 = worst score
Outcome measures
| Measure |
Lingual Endurance Training
n=14 Participants
Participants will complete lingual endurance training 2-3 times a day. Half of the participants will also complete a session of effortful swallows with the device.
Lingual Endurance Training: Participants will participate in 3 training sessions per day for 8 weeks. Some participants will complete 3 sessions of lingual endurance exercise. For example, if the participant completed 100 repetitions during the baseline measurement, they would complete 75 repetitions during their exercise session. Other participants will complete effortful swallows during their 3rd training session. These participants will complete 30 swallows where they are instructed to press their tongue hard on the bulb and swallow their saliva.
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Change From Baseline in Swallowing Quality of Life Questionnaire (SWAL-QoL)
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8.3 score on a scale
Standard Deviation 18.74
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SECONDARY outcome
Timeframe: Baseline and 8 Weekspatient reported outcome tool; 0 = best score, 50 = worst score
Outcome measures
| Measure |
Lingual Endurance Training
n=15 Participants
Participants will complete lingual endurance training 2-3 times a day. Half of the participants will also complete a session of effortful swallows with the device.
Lingual Endurance Training: Participants will participate in 3 training sessions per day for 8 weeks. Some participants will complete 3 sessions of lingual endurance exercise. For example, if the participant completed 100 repetitions during the baseline measurement, they would complete 75 repetitions during their exercise session. Other participants will complete effortful swallows during their 3rd training session. These participants will complete 30 swallows where they are instructed to press their tongue hard on the bulb and swallow their saliva.
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|---|---|
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Change From Baseline Eating Assessment Tool (EAT-10) Score
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-0.0667 score on a scale
Standard Deviation 4.93
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Adverse Events
Lingual Endurance Training
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lingual Endurance Training
n=19 participants at risk
Participants will complete lingual endurance training 2-3 times a day. Half of the participants will also complete a session of effortful swallows with the device.
Lingual Endurance Training: Participants will participate in 3 training sessions per day for 8 weeks. Some participants will complete 3 sessions of lingual endurance exercise. For example, if the participant completed 100 repetitions during the baseline measurement, they would complete 75 repetitions during their exercise session. Other participants will complete effortful swallows during their 3rd training session. These participants will complete 30 swallows where they are instructed to press their tongue hard on the bulb and swallow their saliva.
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|---|---|
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Infections and infestations
Hospitalization
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10.5%
2/19 • Number of events 2 • Participants were enrolled on average 8-10 weeks
Only 2 participants were hospitalized due to non-protocol related reasons
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Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place