DysphagiaPhase 2TPPTNCT01370083
Tongue Pressure Profile Training for Dysphagia Post Stroke
A Phase 2 study testing Tongue Pressure Profile Training and Tongue-Pressure Strength-and-Accuracy Training in people with Dysphagia, run by Toronto Rehabilitation Institute at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Dysphagia
- What is being tested?
- Tongue Pressure Profile Training and Tongue-Pressure Strength-and-Accuracy Training
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2011to Jun 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals with dysphagia characterized by prolonged swallow response duration for 5 cc boluses of thin liquid (i.e., > 350 ms, confirmed in videofluoroscopy).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Canada1 site
Toronto Rehabilitation Institute - University Health Network
Toronto, Ontario, M5G 2A2
About this study
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.
Read the 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.
- Conditions
- Dysphagia
- Being tested
- Tongue Pressure Profile Training, Tongue-Pressure Strength-and-Accuracy Training
- Keywords
- Dysphagia, Viscosity, Tongue, Pressure
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tongue Pressure Profile TrainingBehavioural
Also called Iowa Oral Performance Instrument
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.
Tongue-Pressure Strength-and-Accuracy TrainingBehavioural
Also called Iowa Oral Performance Instrument
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.
| Study group | Role | What they receive |
|---|---|---|
| Stroke: TPPT | Experimental | 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. Receives: Behavioral: Tongue Pressure Profile Training |
| Stroke: TPSAT Control | Active comparator | 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. Receives: Behavioral: Tongue-Pressure Strength-and-Accuracy Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post treatment (12 weeks)
Secondary outcomes (2)
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).
Measured: Post-treatment (12 weeks)
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.
Measured: Post-treatment value
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2011 (estimated)
- Study startSep 2011
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toronto Rehabilitation Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catriona M. Steele, Toronto Rehabilitation Institute
- Investigators
- Catriona M Steele, Ph.D., Principal investigator, Toronto Rehabilitation Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01370083
- Sponsor's protocol ID
- TRI-SRRL-0411-TPPT
- Acronym
- TPPT
- Status last verified
- Jan 2016
- First submitted
- 3 Jun 2011
- Last updated
- 8 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Steele CM, Bayley MA, Peladeau-Pigeon M, Stokely SL. Tongue pressure profile training for dysphagia post stroke (TPPT): study protocol for an exploratory randomized controlled trial. Trials. 2013 May 7;14:126. doi: 10.1186/1745-6215-14-126.
PubMed 23782628
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tongue Pressure Profile Training for Dysphagia Post Stroke
- ClinicalTrials.gov ID
- NCT01370083
- Acronym / sponsor ID
- TPPT / TRI-SRRL-0411-TPPT
- Conditions
- Dysphagia
- Keywords
- Dysphagia, Viscosity, Tongue, Pressure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Toronto Rehabilitation InstituteUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 9 Jun 2011 (estimated)
- Results
- Posted 30 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke: TPPT | Experimental | Behavioral: Tongue Pressure Profile TrainingAdults 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. |
| Stroke: TPSAT Control | Active comparator | Behavioral: Tongue-Pressure Strength-and-Accuracy TrainingIndividuals 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals with dysphagia characterized by prolonged swallow response duration for 5 cc boluses of thin liquid (i.e., > 350 ms, confirmed in videofluoroscopy).
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tongue Pressure Profile TrainingAlso: Iowa Oral Performance Instrument60 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. | Behavioural | Stroke: TPPT |
| Tongue-Pressure Strength-and-Accuracy TrainingAlso: Iowa Oral Performance Instrument60 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. | Behavioural | Stroke: TPSAT Control |
Primary outcome
Change in Swallow Response Time for 5 cc Thin Liquid Swallows
Time frame: 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.
2 secondary outcomes
Penetration-Aspiration Scale Score for 5 cc Thin Liquid Swallows
Time frame: Post-treatment (12 weeks)
Tongue-palate Pressure Amplitude for Maximum Isometric Pressures
Time frame: Post-treatment value
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23782628Steele CM, Bayley MA, Peladeau-Pigeon M, Stokely SL. Tongue pressure profile training for dysphagia post stroke (TPPT): study protocol for an exploratory randomized controlled trial. Trials. 2013 May 7;14:126. doi: 10.1186/1745-6215-14-126.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catriona M Steele, Ph.D. principal investigator
Toronto Rehabilitation Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tongue Pressure Profile Training and Tongue-Pressure Strength-and-Accuracy Training in people with Dysphagia, run by Toronto Rehabilitation Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Swallow Response Time for 5 cc Thin Liquid Swallows (time frame: Post treatment (12 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01370083, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2016.