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Open Access Study protocol

Tongue pressure profile training for dysphagia post stroke (TPPT): study protocol for an exploratory randomized controlled trial

Catriona M Steele123*, Mark A Bayley12, Melanie Péladeau-Pigeon1 and Shauna L Stokely1

Author Affiliations

1 Swallowing Rehabilitation Research Laboratory, Toronto Rehabilitation Institute, University Health Network, 550 University Avenue #12-125, Toronto, ON M5G 2A2, Canada

2 University of Toronto, Toronto, Canada

3 Bloorview Research Institute, Holland Bloorview Kids Rehab, Toronto, Canada

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Trials 2013, 14:126  doi:10.1186/1745-6215-14-126

Published: 7 May 2013

Abstract

Background

It is estimated that approximately 50% of stroke survivors will experience swallowing difficulty, or dysphagia. The associated sequelae of dysphagia include dehydration, malnutrition, and aspiration pneumonia, all of which have can have serious medical consequences. To improve swallowing safety and efficiency, alternative nutritional intake methods (for example, a feeding tube) or a modified diet texture (such as pureed foods or thickened liquids) may be recommended but these modifications may negatively affect quality of life. An alternative approach to treating dysphagia has emerged over the past few years, targeting stronger lingual muscles through maximal isometric pressure tasks. Although these studies have shown promising results, thin-liquid bolus control continues to be challenging for patients with dysphagia. Previous work investigating lingual pressures when healthy participants swallow has suggested that greater task specificity in lingual exercises may yield improved results with thin liquids.

Methods/design

This is a small, exploratory randomized clinical trial being conducted with post-stroke patients 4 to 20 weeks after onset of dysphagia secondary to impaired lingual control. At enrollment, participants are randomly assigned to one of two treatment protocols, either tongue pressure profile training (TPPT) or the control treatment, tongue pressure strength-and-accuracy training (TPSAT). Each treatment protocol consists of 24 sessions of treatment over 8 to 12 weeks with monitoring of tongue pressure as well as a baseline and outcome videofluoroscopic swallowing study. Tongue pressure measures, videofluoroscopic measures, and functional outcome measures will be obtained following training of 60 participants (30 in each condition), to determine whether TPPT yields better outcomes.

Discussion

This study will continue to explore options beyond tube feeding and modified diets for people with neurogenic dysphagia following stroke. Should the novel protocol, TPPT, prove to be more effective than the TPSAT protocol, this may influence standards of care and best practices for patients with dysphagia involving impaired thin-liquid control as a result of stroke.

Trial registration

Clinicaltrials.gov http://NCT01370083 webciteNCT01370083

Keywords:
Deglutition; Dysphagia; Penetration-aspiration; Pressure; Tongue