Tongue Pressure Profile Training for Dysphagia Post Stroke (TPPT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Catriona M. Steele, Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier:
NCT01370083
First received: June 3, 2011
Last updated: January 14, 2016
Last verified: January 2016
Results First Received: November 24, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Dysphagia
Interventions: Behavioral: Tongue Pressure Profile Training
Behavioral: Tongue-Pressure Strength-and-Accuracy Training

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Stroke: TPPT     Stroke: TPSAT Control  
STARTED     7     7  
COMPLETED     5     6  
NOT COMPLETED     2     1  
Lost to Follow-up                 2                 0  
Adverse Event                 0                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Individuals with dysphagia following stroke (within 4-16 weeks post onset) with radiographically confirmed difficulties with thin liquid bolus control.

Reporting Groups
  Description
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.

Total Total of all reporting groups

Baseline Measures
    Stroke: TPPT     Stroke: TPSAT Control     Total  
Number of Participants  
[units: participants]
  7     7     14  
Age  
[units: years]
Mean (Full Range)
  75  
  (56 to 84)  
  67  
  (49 to 89)  
  71  
  (49 to 89)  
Gender  
[units: participants]
     
Female     3     2     5  
Male     4     5     9  
Region of Enrollment  
[units: participants]
     
Canada     7     7     14  
Tongue Strength, Continuous [1]
[units: Kilopascals]
Mean (Standard Deviation)
  12.71  (7.48)     25.71  (8.36)     19  (10)  
Swallow Response Time (thin liquids), Categorical [2]
[units: participants]
  7     7     14  
Penetration-Aspiration, Categorical [3]
[units: participants]
     
Abnormal Scores (3 or higher)     4     4     8  
Normal Scores (1 or 2)     3     3     6  
[1] 1 Repetition Maximum Isometric Tongue-Palate Pressure measured across 3 repetitions of maximum isometric tongue pressure generation using the Iowa Oral Performance Instrument, with the bulb located in a posterior position in the mouth (with the flat edge of the bulb aligned with the first molar tooth).
[2] This is a categorical measure (within vs.above normal limits) of the time interval between a thin liquid bolus entering the pharynx (passing the shadow of the ramus of mandible) and onset of upward-anterior hyolaryngeal excursion for the swallow. The continuous parameter is measured in milliseconds from videofluoroscopy. Durations < 350 ms are considered within normal limits; those > 350 ms are considered prolonged. Prolonged swallow response time on thin liquid swallows at baseline was an inclusion criterion for this study. We report the # of participants with values > 350 ms.
[3] The 8-point Penetration-Aspiration Scale is an ordinal rating scale used to rate the severity of airway invasion during swallowing. Scores of 1 and 2 are considered normal. Here we report the number of participants displaying abnormal scores (i.e. of 3 and higher) vs normal scores (1 or 2) on thin liquid swallows in videofluoroscopy.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Swallow Response Time for 5 cc Thin Liquid Swallows   [ Time Frame: Post treatment (12 weeks) ]

2.  Secondary:   Penetration-Aspiration Scale Score for 5 cc Thin Liquid Swallows   [ Time Frame: Post-treatment (12 weeks) ]

3.  Secondary:   Tongue-palate Pressure Amplitude for Maximum Isometric Pressures   [ Time Frame: Post-treatment value ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Prof. Catriona Steele
Organization: Toronto Rehabilitation Institute - University Health Network
phone: 4165973422 ext 7603
e-mail: catriona.steele@uhn.ca


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Catriona M. Steele, Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier: NCT01370083     History of Changes
Other Study ID Numbers: TRI-SRRL-0411-TPPT
Study First Received: June 3, 2011
Results First Received: November 24, 2015
Last Updated: January 14, 2016
Health Authority: Canada: Tri-Council for Research Ethics