Trial Outcomes & Findings for Tongue Pressure Profile Training for Dysphagia Post Stroke (NCT NCT01370083)
NCT ID: NCT01370083
Last Updated: 2016-02-08
Results Overview
Swallow response time (the time duration between bolus passing the ramus of the shadow of the mandible and onset of hyolaryngeal excursion for airway protection 5cc thin liquid barium boluses in videofluoroscopy. Measures \> 350 ms are considered to reflect impairment and a heightened risk of penetration-aspiration. The participant's mean swallow response time will be calculated across a series of 3 X 5 cc swallows and then reduced to a binary score \< vs \> 350 milliseconds.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
14 participants
Primary outcome timeframe
Post treatment (12 weeks)
Results posted on
2016-02-08
Participant Flow
Participant milestones
| Measure |
Stroke: TPPT
Adults with dysphagia post stroke (within 4-16 weeks of onset) who have radiographically confirmed difficulties with thin liquid bolus control. Individuals will complete 24 sessions of tongue-pressure-profile training over 8-12 weeks.
Tongue Pressure Profile Training: 60 tongue-pressure tasks per session, emphasizing control of the slope of tongue pressure release, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with signals displayed on a computer.
|
Stroke: TPSAT Control
Individuals with dysphagia (within 4-16 weeks post stroke) who demonstrate difficulties with thin liquid control on videofluoroscopy. Individuals will complete 24 sessions of tongue-pressure strength-and-accuracy training over 8-12 weeks.
Tongue-Pressure Strength-and-Accuracy Training: 60 tongue-pressure tasks per session, emphasizing maximum effort strength tasks and accuracy targets within 20-95% of each patient's maximum, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with amplitude output in kiloPascals displayed on an LCD screen.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
|
Overall Study
COMPLETED
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Stroke: TPPT
Adults with dysphagia post stroke (within 4-16 weeks of onset) who have radiographically confirmed difficulties with thin liquid bolus control. Individuals will complete 24 sessions of tongue-pressure-profile training over 8-12 weeks.
Tongue Pressure Profile Training: 60 tongue-pressure tasks per session, emphasizing control of the slope of tongue pressure release, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with signals displayed on a computer.
|
Stroke: TPSAT Control
Individuals with dysphagia (within 4-16 weeks post stroke) who demonstrate difficulties with thin liquid control on videofluoroscopy. Individuals will complete 24 sessions of tongue-pressure strength-and-accuracy training over 8-12 weeks.
Tongue-Pressure Strength-and-Accuracy Training: 60 tongue-pressure tasks per session, emphasizing maximum effort strength tasks and accuracy targets within 20-95% of each patient's maximum, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with amplitude output in kiloPascals displayed on an LCD screen.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Tongue Pressure Profile Training for Dysphagia Post Stroke
Baseline characteristics by cohort
| Measure |
Stroke: TPPT
n=7 Participants
Adults with dysphagia post stroke (within 4-16 weeks of onset) who have radiographically confirmed difficulties with thin liquid bolus control. Individuals will complete 24 sessions of tongue-pressure-profile training over 8-12 weeks.
Tongue Pressure Profile Training: 60 tongue-pressure tasks per session, emphasizing control of the slope of tongue pressure release, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with signals displayed on a computer.
|
Stroke: TPSAT Control
n=7 Participants
Individuals with dysphagia (within 4-16 weeks post stroke) who demonstrate difficulties with thin liquid control on videofluoroscopy. Individuals will complete 24 sessions of tongue-pressure strength-and-accuracy training over 8-12 weeks.
Tongue-Pressure Strength-and-Accuracy Training: 60 tongue-pressure tasks per session, emphasizing maximum effort strength tasks and accuracy targets within 20-95% of each patient's maximum, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with amplitude output in kiloPascals displayed on an LCD screen.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
75 years
n=5 Participants
|
67 years
n=7 Participants
|
71 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Tongue Strength, Continuous
|
12.71 Kilopascals
STANDARD_DEVIATION 7.48 • n=5 Participants
|
25.71 Kilopascals
STANDARD_DEVIATION 8.36 • n=7 Participants
|
19 Kilopascals
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Swallow Response Time (thin liquids), Categorical
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Penetration-Aspiration, Categorical
Abnormal Scores (3 or higher)
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Penetration-Aspiration, Categorical
Normal Scores (1 or 2)
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Post treatment (12 weeks)Swallow response time (the time duration between bolus passing the ramus of the shadow of the mandible and onset of hyolaryngeal excursion for airway protection 5cc thin liquid barium boluses in videofluoroscopy. Measures \> 350 ms are considered to reflect impairment and a heightened risk of penetration-aspiration. The participant's mean swallow response time will be calculated across a series of 3 X 5 cc swallows and then reduced to a binary score \< vs \> 350 milliseconds.
Outcome measures
| Measure |
Stroke: TPPT
n=6 Participants
Adults with dysphagia post stroke (within 4-16 weeks of onset) who have radiographically confirmed difficulties with thin liquid bolus control. Individuals will complete 24 sessions of tongue-pressure-profile training over 8-12 weeks.
Tongue Pressure Profile Training: 60 tongue-pressure tasks per session, emphasizing control of the slope of tongue pressure release, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with signals displayed on a computer.
|
Stroke: TPSAT Control
n=5 Participants
Individuals with dysphagia (within 4-16 weeks post stroke) who demonstrate difficulties with thin liquid control on videofluoroscopy. Individuals will complete 24 sessions of tongue-pressure strength-and-accuracy training over 8-12 weeks.
Tongue-Pressure Strength-and-Accuracy Training: 60 tongue-pressure tasks per session, emphasizing maximum effort strength tasks and accuracy targets within 20-95% of each patient's maximum, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with amplitude output in kiloPascals displayed on an LCD screen.
|
|---|---|---|
|
Change in Swallow Response Time for 5 cc Thin Liquid Swallows
Number with values < 350 ms
|
2 participants
|
2 participants
|
|
Change in Swallow Response Time for 5 cc Thin Liquid Swallows
Number with values > 350 ms
|
4 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Post-treatment (12 weeks)Population: Participants with complete pre and post-treatment videofluoroscopy data available.
The Penetration-Aspiration Scale is an 8-point ordinal scale that addresses the depth of airway invasion and response to airway invasion during swallowing. We will measure penetration-aspiration for a series of 3 X 5 cc thin liquid swallows in videofluoroscopy. The participant's worst score will be taken to reflect their swallowing safety. This score will be collapsed into a binary score \< vs. \> 3 on the scale, reflecting material entering and remaining in or below the supraglottic space (versus transient entry or no entry at all).
Outcome measures
| Measure |
Stroke: TPPT
n=6 Participants
Adults with dysphagia post stroke (within 4-16 weeks of onset) who have radiographically confirmed difficulties with thin liquid bolus control. Individuals will complete 24 sessions of tongue-pressure-profile training over 8-12 weeks.
Tongue Pressure Profile Training: 60 tongue-pressure tasks per session, emphasizing control of the slope of tongue pressure release, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with signals displayed on a computer.
|
Stroke: TPSAT Control
n=5 Participants
Individuals with dysphagia (within 4-16 weeks post stroke) who demonstrate difficulties with thin liquid control on videofluoroscopy. Individuals will complete 24 sessions of tongue-pressure strength-and-accuracy training over 8-12 weeks.
Tongue-Pressure Strength-and-Accuracy Training: 60 tongue-pressure tasks per session, emphasizing maximum effort strength tasks and accuracy targets within 20-95% of each patient's maximum, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with amplitude output in kiloPascals displayed on an LCD screen.
|
|---|---|---|
|
Penetration-Aspiration Scale Score for 5 cc Thin Liquid Swallows
Swallowing safety within normal limits (scores <3)
|
2 participants
|
4 participants
|
|
Penetration-Aspiration Scale Score for 5 cc Thin Liquid Swallows
Swallowing safety impaired (scores >2)
|
4 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Post-treatment valuePopulation: Individuals with complete pre and post-treatment data available
We will measure the amplitude of peak tongue-pressure amplitudes on maximum isometric pressure tasks performed using the Iowa Oral Performance Instrument. The maximum amplitude across a series of 3 maximum isometric pressure tasks performed with the bulb in a posterior position (flat end aligned with the first molar tooth) will be used to document tongue strength.
Outcome measures
| Measure |
Stroke: TPPT
n=6 Participants
Adults with dysphagia post stroke (within 4-16 weeks of onset) who have radiographically confirmed difficulties with thin liquid bolus control. Individuals will complete 24 sessions of tongue-pressure-profile training over 8-12 weeks.
Tongue Pressure Profile Training: 60 tongue-pressure tasks per session, emphasizing control of the slope of tongue pressure release, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with signals displayed on a computer.
|
Stroke: TPSAT Control
n=5 Participants
Individuals with dysphagia (within 4-16 weeks post stroke) who demonstrate difficulties with thin liquid control on videofluoroscopy. Individuals will complete 24 sessions of tongue-pressure strength-and-accuracy training over 8-12 weeks.
Tongue-Pressure Strength-and-Accuracy Training: 60 tongue-pressure tasks per session, emphasizing maximum effort strength tasks and accuracy targets within 20-95% of each patient's maximum, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with amplitude output in kiloPascals displayed on an LCD screen.
|
|---|---|---|
|
Tongue-palate Pressure Amplitude for Maximum Isometric Pressures
|
28.45 Kilopascals
Standard Deviation 18.03
|
43.84 Kilopascals
Standard Deviation 13.33
|
Adverse Events
Stroke: TPPT
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Stroke: TPSAT Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stroke: TPPT
n=7 participants at risk
Adults with dysphagia post stroke (within 4-16 weeks of onset) who have radiographically confirmed difficulties with thin liquid bolus control. Individuals will complete 24 sessions of tongue-pressure-profile training over 8-12 weeks.
Tongue Pressure Profile Training: 60 tongue-pressure tasks per session, emphasizing control of the slope of tongue pressure release, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with signals displayed on a computer.
|
Stroke: TPSAT Control
n=7 participants at risk
Individuals with dysphagia (within 4-16 weeks post stroke) who demonstrate difficulties with thin liquid control on videofluoroscopy. Individuals will complete 24 sessions of tongue-pressure strength-and-accuracy training over 8-12 weeks.
Tongue-Pressure Strength-and-Accuracy Training: 60 tongue-pressure tasks per session, emphasizing maximum effort strength tasks and accuracy targets within 20-95% of each patient's maximum, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with amplitude output in kiloPascals displayed on an LCD screen.
|
|---|---|---|
|
Nervous system disorders
New Stroke Requiring Acute Care Hospitalization
|
14.3%
1/7 • Number of events 1 • During the 3 months of active participation in the study
|
0.00%
0/7 • During the 3 months of active participation in the study
|
Other adverse events
Adverse event data not reported
Additional Information
Prof. Catriona Steele
Toronto Rehabilitation Institute - University Health Network
Phone: 4165973422
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place