search
Back to results

Tongue Pressure Profile Training for Dysphagia Post Stroke (TPPT)

Primary Purpose

Dysphagia

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Tongue Pressure Profile Training
Tongue-Pressure Strength-and-Accuracy Training
Sponsored by
Toronto Rehabilitation Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysphagia focused on measuring Dysphagia, Viscosity, Tongue, Pressure

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Toronto Rehabilitation Institute - University Health Network

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stroke: TPPT

Stroke: TPSAT Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.

Full Information

First Posted
June 3, 2011
Last Updated
January 14, 2016
Sponsor
Toronto Rehabilitation Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT01370083
Brief Title
Tongue Pressure Profile Training for Dysphagia Post Stroke
Acronym
TPPT
Official Title
Tongue Pressure Profile Training for Dysphagia Post Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Toronto Rehabilitation Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia
Keywords
Dysphagia, Viscosity, Tongue, Pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stroke: TPPT
Arm Type
Experimental
Arm Description
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.
Arm Title
Stroke: TPSAT Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Tongue Pressure Profile Training
Other Intervention Name(s)
Iowa Oral Performance Instrument
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Tongue-Pressure Strength-and-Accuracy Training
Other Intervention Name(s)
Iowa Oral Performance Instrument
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Swallow Response Time for 5 cc Thin Liquid Swallows
Description
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)
Secondary Outcome Measure Information:
Title
Penetration-Aspiration Scale Score for 5 cc Thin Liquid Swallows
Description
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)
Title
Tongue-palate Pressure Amplitude for Maximum Isometric Pressures
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catriona M Steele, Ph.D.
Organizational Affiliation
Toronto Rehabilitation Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Rehabilitation Institute - University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2A2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
23782628
Citation
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.
Results Reference
derived

Learn more about this trial

Tongue Pressure Profile Training for Dysphagia Post Stroke

We'll reach out to this number within 24 hrs