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Tongue Pressure Profile Training for Dysphagia Post Stroke

Tongue Pressure Profile Training for Dysphagia Post Stroke

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01370083
Acronym
TPPT
Enrollment
14
Registered
2011-06-09
Start date
2011-09-30
Completion date
2015-06-30
Last updated
2016-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysphagia

Keywords

Dysphagia, Viscosity, Tongue, Pressure

Brief summary

People with swallowing impairment experience particular difficulty swallowing thin liquids safely; the fast flow of liquids makes them difficult to control. The tongue plays a critical role in containing liquids in the mouth, channeling the direction of their flow towards the pharynx (throat) and controlling their flow along that channel. The investigators are engaged in a program of research to better understand tongue function in swallowing, particularly with respect to controlling the flow of liquids. In this study the investigators will compare two different tongue-pressure resistance training protocols, to determine whether a protocol that emphasizes strength-and-accuracy or one that emphasizes pressure timing work better for improving liquid flow control in swallowing.

Detailed description

Drinking thin liquids is something that most of us take for granted; yet this task is one that many patients with dysphagia (swallowing impairment) cannot do safely. Instead, these individuals receive liquids in thickened form: thickened juice, thickened coffee… even thickened water. The literature tells us that patients dislike the taste and feel of thickened liquids and find that their thirst is not quenched. Patients on thickened liquids are prone to inadequate fluid intake and dehydration. Many patients are non- compliant and drink thin liquids, despite documented risk for aspiration (i.e., airway invasion) and its consequences. Given these limitations, it is important that dysphagia researchers continue to pursue treatments with the potential to restore safe and functional thin liquid swallowing in people with dysphagia. In the past decade, tongue pressure resistance training has emerged as an innovative treatment for dysphagia. Dr. JoAnne Robbins (University of Wisconsin - Madison)has shown that 8-weeks of intensive tongue pressure resistance training improves tongue strength in healthy seniors and those with dysphagia following stroke. In our lab (the Swallowing Rehabilitation Research Laboratory at the Toronto Rehabilitation Institute), the investigators have studied a variation on Dr. Robbins' treatment called Tongue Pressure Strength and Accuracy Training. This approach also improves tongue strength and improves aspiration. However, the investigators continue to be bothered by the fact that people with dysphagia post stroke often have difficulty controlling the flow of thin liquids, even after these strength-focused protocols of tongue-pressure training. The investigators have recently completed a study of tongue pressures profiles (strength and timing) in healthy people, which shows that tongue pressures are released more slowly with thin liquids than with thick liquids. This reveals active control of thin liquid flow, and suggests that both the strength and timing of tongue pressure play a role in flow-control. The investigators believe that treatment outcomes may be better if tongue pressure resistance training protocols take both strength and timing into consideration. To this end, the investigators have recently identified a subset of tongue pressure training tasks for which the strength and timing profile of tongue pressure onset and release is similar to that seen in liquid swallowing. The investigators propose that a treatment protocol will have better potential to yield favourable outcomes for thin liquid flow-control if it focuses on such tasks. In this study, the investigators want to determine whether tongue pressure profile training, which addresses both timing and amplitude issues in tongue pressure generation, yields better functional outcomes in swallowing than strength-and-accuracy focused treatment. The investigators will pursue this question in a small randomized prospective trial, building on our prior work in this area. The investigators will recruit 60 new patients with who demonstrate thin liquid flow-control difficulties secondary to stroke. These individuals will be randomized either to tongue-pressure strength-and-accuracy training (TPSAT) or to the novel intervention, tongue-pressure profile training (TPPT). The investigators will study their treatment outcomes after 12 weeks (24-sessions) of treatment.

Interventions

BEHAVIORALTongue-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.

BEHAVIORALTongue 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.

Sponsors

Toronto Rehabilitation Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

Inclusion criteria

* Individuals with dysphagia characterized by prolonged swallow response duration for 5 cc boluses of thin liquid (i.e., \> 350 ms, confirmed in videofluoroscopy).

Exclusion criteria

* premorbid reported history of swallowing, motor speech, gastro-esophageal or neurological difficulties. * prior history of surgery to the speech apparatus (other than routine tonsillectomy or adenoidectomy).

Design outcomes

Primary

MeasureTime frameDescription
Change in Swallow Response Time for 5 cc Thin Liquid SwallowsPost 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.

Secondary

MeasureTime frameDescription
Penetration-Aspiration Scale Score for 5 cc Thin Liquid SwallowsPost-treatment (12 weeks)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).
Tongue-palate Pressure Amplitude for Maximum Isometric PressuresPost-treatment valueWe 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.

Countries

Canada

Participant flow

Participants by arm

ArmCount
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.
7
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.
7
Total14

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyAdverse Event01
Overall StudyLost to Follow-up20

Baseline characteristics

CharacteristicStroke: TPSAT ControlTotalStroke: TPPT
Age, Continuous67 years71 years75 years
Penetration-Aspiration, Categorical
Abnormal Scores (3 or higher)
4 participants8 participants4 participants
Penetration-Aspiration, Categorical
Normal Scores (1 or 2)
3 participants6 participants3 participants
Region of Enrollment
Canada
7 participants14 participants7 participants
Sex: Female, Male
Female
2 Participants5 Participants3 Participants
Sex: Female, Male
Male
5 Participants9 Participants4 Participants
Swallow Response Time (thin liquids), Categorical7 participants14 participants7 participants
Tongue Strength, Continuous25.71 Kilopascals
STANDARD_DEVIATION 8.36
19 Kilopascals
STANDARD_DEVIATION 10
12.71 Kilopascals
STANDARD_DEVIATION 7.48

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 70 / 7
serious
Total, serious adverse events
1 / 70 / 7

Outcome results

Primary

Change in Swallow Response Time for 5 cc Thin Liquid Swallows

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.

Time frame: Post treatment (12 weeks)

ArmMeasureGroupValue (NUMBER)
Stroke: TPPTChange in Swallow Response Time for 5 cc Thin Liquid SwallowsNumber with values < 350 ms2 participants
Stroke: TPPTChange in Swallow Response Time for 5 cc Thin Liquid SwallowsNumber with values > 350 ms4 participants
Stroke: TPSAT ControlChange in Swallow Response Time for 5 cc Thin Liquid SwallowsNumber with values < 350 ms2 participants
Stroke: TPSAT ControlChange in Swallow Response Time for 5 cc Thin Liquid SwallowsNumber with values > 350 ms3 participants
Secondary

Penetration-Aspiration Scale Score for 5 cc Thin Liquid Swallows

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).

Time frame: Post-treatment (12 weeks)

Population: Participants with complete pre and post-treatment videofluoroscopy data available.

ArmMeasureGroupValue (NUMBER)
Stroke: TPPTPenetration-Aspiration Scale Score for 5 cc Thin Liquid SwallowsSwallowing safety within normal limits (scores <3)2 participants
Stroke: TPPTPenetration-Aspiration Scale Score for 5 cc Thin Liquid SwallowsSwallowing safety impaired (scores >2)4 participants
Stroke: TPSAT ControlPenetration-Aspiration Scale Score for 5 cc Thin Liquid SwallowsSwallowing safety within normal limits (scores <3)4 participants
Stroke: TPSAT ControlPenetration-Aspiration Scale Score for 5 cc Thin Liquid SwallowsSwallowing safety impaired (scores >2)1 participants
Secondary

Tongue-palate Pressure Amplitude for Maximum Isometric Pressures

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.

Time frame: Post-treatment value

Population: Individuals with complete pre and post-treatment data available

ArmMeasureValue (MEAN)Dispersion
Stroke: TPPTTongue-palate Pressure Amplitude for Maximum Isometric Pressures28.45 KilopascalsStandard Deviation 18.03
Stroke: TPSAT ControlTongue-palate Pressure Amplitude for Maximum Isometric Pressures43.84 KilopascalsStandard Deviation 13.33

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026