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Dysphagia | Tongue Pressure Profile Training for Dysphagia Post Stroke

Dysphagia research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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).

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Dysphagia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Behavioral:Tongue Pressure Profile Training60 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.

Behavioral:Tongue-Pressure Strength-and-Accuracy Training60 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Stroke: TPPTAdults 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 ControlIndividuals 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.

Study Status

Completed

Start Date: September 2011

Completed Date: June 2015

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Change in Swallow Response Time for 5 cc Thin Liquid Swallows

Secondary Outcome: Penetration-Aspiration Scale Score for 5 cc Thin Liquid Swallows

Study sponsors, principal investigator, and references

Principal Investigator: Catriona M Steele, Ph.D.

Lead Sponsor: Toronto Rehabilitation Institute

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01370083

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