Tongue Pressure Profile Training for Dysphagia Post Stroke
TPPT
1 other identifier
interventional
14
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2011
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 3, 2011
CompletedFirst Posted
Study publicly available on registry
June 9, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedResults Posted
Study results publicly available
December 30, 2015
CompletedFebruary 8, 2016
January 1, 2016
3.8 years
June 3, 2011
November 24, 2015
January 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Post treatment (12 weeks)
Secondary Outcomes (2)
Penetration-Aspiration Scale Score for 5 cc Thin Liquid Swallows
Post-treatment (12 weeks)
Tongue-palate Pressure Amplitude for Maximum Isometric Pressures
Post-treatment value
Study Arms (2)
Stroke: TPPT
EXPERIMENTALAdults 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 COMPARATORIndividuals 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Individuals with dysphagia characterized by prolonged swallow response duration for 5 cc boluses of thin liquid (i.e., \> 350 ms, confirmed in videofluoroscopy).
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Toronto Rehabilitation Institute - University Health Network
Toronto, Ontario, M5G 2A2, Canada
Related Publications (1)
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.
PMID: 23782628DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Prof. Catriona Steele
- Organization
- Toronto Rehabilitation Institute - University Health Network
Study Officials
- PRINCIPAL INVESTIGATOR
Catriona M Steele, Ph.D.
Toronto Rehabilitation Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Scientist
Study Record Dates
First Submitted
June 3, 2011
First Posted
June 9, 2011
Study Start
September 1, 2011
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
February 8, 2016
Results First Posted
December 30, 2015
Record last verified: 2016-01