Tongue Pressure Profile Training for Dysphagia Post Stroke (TPPT)
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ClinicalTrials.gov Identifier: NCT01370083 |
Recruitment Status
:
Completed
First Posted
: June 9, 2011
Results First Posted
: December 30, 2015
Last Update Posted
: February 8, 2016
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Tracking Information | ||||
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First Submitted Date ICMJE | June 3, 2011 | |||
First Posted Date ICMJE | June 9, 2011 | |||
Results First Submitted Date | November 24, 2015 | |||
Results First Posted Date | December 30, 2015 | |||
Last Update Posted Date | February 8, 2016 | |||
Study Start Date ICMJE | September 2011 | |||
Actual Primary Completion Date | June 2015 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE |
Change in Penetration-Aspiration Scale [ Time Frame: Post treatment (12 weeks) ] Penetration or aspiration level (entry of material into the airway) on 5cc thin liquid barium boluses in videofluoroscopy, measured using an 8-point scale. Post-treatment score will be compared to baseline pre-treatment measures.
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Change History | Complete list of historical versions of study NCT01370083 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Change in bolus control for thin liquids on videofluoroscopy versus baseline [ Time Frame: Post-treatment (12 weeks) ] Ability to hold a thin liquid bolus of specified volume in the oral cavity for a specified time duration without material spilling over the tongue base into the pharynx. Post-treatment measures will be compared to baseline pre-treatment performance.
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Tongue Pressure Profile Training for Dysphagia Post Stroke | |||
Official Title ICMJE | Tongue Pressure Profile Training for Dysphagia Post Stroke | |||
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. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Dysphagia | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Steele CM, Bayley MA, Péladeau-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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
14 | |||
Original Estimated Enrollment ICMJE |
60 | |||
Actual Study Completion Date | June 2015 | |||
Actual Primary Completion Date | June 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 100 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Canada | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01370083 | |||
Other Study ID Numbers ICMJE | TRI-SRRL-0411-TPPT | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Catriona M. Steele, Toronto Rehabilitation Institute | |||
Study Sponsor ICMJE | Toronto Rehabilitation Institute | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Toronto Rehabilitation Institute | |||
Verification Date | January 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |