Tongue Pressure Profile Training for Dysphagia Post Stroke (TPPT)

Tracking Information
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; (submitted: March 25, 2013)	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.
Original Primary Outcome Measures ICMJE; (submitted: June 8, 2011)	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.
Change History	Complete list of historical versions of study NCT01370083 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: November 24, 2015)	Penetration-Aspiration Scale Score for 5 cc Thin Liquid Swallows [ Time Frame: Post-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 Pressures [ Time Frame: Post-treatment value ]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.
Original Secondary Outcome Measures ICMJE; (submitted: June 8, 2011)	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.
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.
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Dysphagia
Intervention ICMJE	Behavioral: 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. Other Name: Iowa Oral Performance Instrument; Behavioral: 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. Other Name: Iowa Oral Performance Instrument
Study Arms	Experimental: 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. Intervention: Behavioral: Tongue Pressure Profile Training; Active Comparator: 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. Intervention: Behavioral: Tongue-Pressure Strength-and-Accuracy Training
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.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: January 14, 2016)	14
Original Estimated Enrollment ICMJE; (submitted: June 8, 2011)	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: 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).
Sex/Gender	Sexes Eligible for Study: All
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	Principal Investigator: Catriona M Steele, Ph.D. Toronto Rehabilitation Institute
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