Clinical trial NCT03969095: Tongue Pressure Resistance Training for Swallowing Impairment Post-Stroke
Official title: Tongue Pressure Resistance Training for Swallowing Impairment Post-Stroke
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Dysphagia
Keywords: Stroke
Dysphagia
Rehabilitation
Videofluoroscopy
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Marianjoy Rehabilitation Hospital & Clinics
First posted: 2019-05-31
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized crossover trial
Primary purpose: TREATMENT

Brief summary: For patients who have suffered a stroke, tongue strength may be decreased compared to healthy individuals. Research on strengthening the tongue in the stroke population has shown positive effects of a tongue resistance training protocol. Research also suggests that swallow safety, or protection of the airway, may be improved as a result of such interventions, however the mechanism of improvement remains poorly understood. This study aims to determine what aspects of the swallowing mechanism (response time, movement, etc. of different structures) are directly impacted in order to provide guidance to clinicians using such treatments.

Detailed description: Swallowing dysfunction (dysphagia) following stroke results from damage to sensory and motor nerve pathways, impairing muscular physiology and impacting swallow timeliness and airway closure. People with dysphagia experience impaired swallowing safety (entry of food or liquid into the airway - aspiration) and/or impaired swallowing efficiency (food or liquid remaining in the oropharyngeal cavities after the swallow - residue). People with dysphagia following stroke are more likely to experience aspiration pneumonia, which has been associated with higher mortality rates.

The tongue functions to contain food and liquid within the oral cavity before the bolus moves into the pharynx. The tongue generates the primary driving forces, which carry the bolus through the pharynx; consequently, impairments in tongue function can affect both swallowing safety and efficiency. For people who have experienced a stroke, lingual strength is decreased compared to healthy participants. Tongue pressure resistance training has been utilized as an intervention in this population, and has been shown to positively influence tongue strength. It remains unclear whether changes in tongue pressure impact swallowing mechanisms, safety, and efficiency for patients who complete these interventions. In particular, the impact of tongue pressure resistance training on swallow timeliness (swallow onset timing, airway closure reaction time, speed of hyolaryngeal movement) remains unknown. This study will be a randomized trial of tongue pressure resistance training in people with tongue weakness and impaired swallowing safety post-stroke. The goal is to understand the physiological changes that occur as an outcome of tongue pressure resistance training and their relationship to swallowing safety and efficiency. Additionally, the impact of a training protocol involving a home practice component to delineate the impact of patient-driven practice will be explored.

A sample of approximately 40 patients will be enrolled. Participants will complete an 8-week program involving a 4-week course of tongue-pressure resistance training and a 4-week no-treatment phase. Participants will be randomized either to an immediate treatment group (followed by a 4-week post-treatment detraining phase) or to a delayed treatment group involving a 4-week waiting period prior to beginning training. Swallowing outcomes will be measured based on videofluoroscopic swallowing studies (VFSS) performed at baseline, 4-weeks and 8-weeks post enrollment. The tongue pressure resistance training program will involve practice of tongue-palate pressure generation tasks and swallowing tasks, with biofeedback provided using the Iowa Oral Performance Instrument (IOPI).

Eligibility criteria: Inclusion Criteria:

* English-speaking adults
* A confirmed diagnosis of ischemic stroke (including hemispheric, cortical or subcortical and excluding cerebellum and brainstem locations within 3 months following the stroke) identified via CT or MRI
* Eligible participants will display decreased tongue pressure as measured by the Iowa Oral Performance Instrument (IOPI), and show evidence of dysphagia (safety or efficiency concerns) on baseline VFSS with thin or mildly thick liquid stimuli.

Exclusion Criteria:

* History of head and neck cancer
* Radical neck dissection (e.g. anterior cervical surgery fusions) or neck/ oropharyngeal surgery (not excluded - tonsillectomy, adenoidectomy, tracheostomy)
* Past medical history of any neurological disease other than stroke (e.g. Multiple Sclerosis, Parkinson Disease, Amyotrophic Lateral Sclerosis, Traumatic Brain Injury)
* Oral apraxia, impairing the participant's ability to complete exercises
* Cognitive or receptive communication difficulties that preclude the participant's ability to follow study instructions
* Allergies to barium, potato starch, corn starch, xanthan gum, milk products, or latex

Primary outcomes:
measure: Penetration-Aspiration Scale [PAS]
timeFrame: Pre-treatment baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Number of swallows per bolus
timeFrame: Pre-treatment baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Pixel-based measurement of post-swallow pharyngeal residue
timeFrame: Pre-treatment baseline, 4 weeks after baseline, 8 weeks after baseline
measure: International Dysphagia Diet Standardisation Initiative Functional Diet Scale
timeFrame: Pre-treatment baseline, 4 weeks after baseline, 8 weeks after baseline
Secondary outcomes:
measure: Tongue Strength
timeFrame: Pre-treatment baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Saliva Swallow Tongue Pressures
timeFrame: Pre-treatment baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Swallow Timing Swallow Timing
timeFrame: Pre-treatment baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Hyoid Kinematics
timeFrame: Pre-treatment baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Pharyngeal constriction
timeFrame: Pre-treatment baseline, 4 weeks after baseline, 8 weeks after baseline
Other outcomes:
Locations:
city: Wheaton
country: United States
facility: Marianjoy Hospital
state: Illinois
city: Toronto
country: Canada
facility: Toronto Rehabilitation Institute - University Health Network
state: Ontario
Study officials:
affiliation: KITE - Toronto Rehabilitation Institute - University Health Network
name: Catriona Steele
role: PRINCIPAL_INVESTIGATOR
affiliation: University Health Network, Toronto
name: Denyse Richardson
role: PRINCIPAL_INVESTIGATOR
affiliation: Marianjoy Hospital
name: Michael Pietrantoni
role: PRINCIPAL_INVESTIGATOR
affiliation: Marianjoy Hospital
name: Susan Brady
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cho YS, Oh DH, Paik YR, Lee JH, Park JS. Effects of bedside self-exercise on oropharyngeal swallowing function in stroke patients with dysphagia: a pilot study. J Phys Ther Sci. 2017 Oct;29(10):1815-1816. doi: 10.1589/jpts.29.1815. Epub 2017 Oct 21.
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citation: Kim HD, Choi JB, Yoo SJ, Chang MY, Lee SW, Park JS. Tongue-to-palate resistance training improves tongue strength and oropharyngeal swallowing function in subacute stroke survivors with dysphagia. J Oral Rehabil. 2017 Jan;44(1):59-64. doi: 10.1111/joor.12461.
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citation: McKenna VS, Zhang B, Haines MB, Kelchner LN. A Systematic Review of Isometric Lingual Strength-Training Programs in Adults With and Without Dysphagia. Am J Speech Lang Pathol. 2017 May 17;26(2):524-539. doi: 10.1044/2016_AJSLP-15-0051.
citation: Park JS, Kim HJ, Oh DH. Effect of tongue strength training using the Iowa Oral Performance Instrument in stroke patients with dysphagia. J Phys Ther Sci. 2015 Dec;27(12):3631-4. doi: 10.1589/jpts.27.3631. Epub 2015 Dec 28.
citation: Robbins J, Kays SA, Gangnon RE, Hind JA, Hewitt AL, Gentry LR, Taylor AJ. The effects of lingual exercise in stroke patients with dysphagia. Arch Phys Med Rehabil. 2007 Feb;88(2):150-8. doi: 10.1016/j.apmr.2006.11.002.
citation: Steele CM, Bayley MT, Peladeau-Pigeon M, Nagy A, Namasivayam AM, Stokely SL, Wolkin T. A Randomized Trial Comparing Two Tongue-Pressure Resistance Training Protocols for Post-Stroke Dysphagia. Dysphagia. 2016 Jun;31(3):452-61. doi: 10.1007/s00455-016-9699-5. Epub 2016 Mar 2.