Clinical Trial: Tongue Pressure Profile Training for Dysphagia Post Stroke

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Summary:

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
Sponsor: Toronto Rehabilitation Institute

Current Primary Outcome: 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: 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.


Current Secondary Outcome:

  • 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: 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.


Information By: Toronto Rehabilitation Institute

Dates:
Date Received: June 3, 2011
Date Started: September 2011
Date Completion:
Last Updated: January 14, 2016
Last Verified: January 2016