Tongue Pressure Resistance Training for Swallowing Impairment Post-Stroke

NCT03969095 | Terminated

• 1 other identifier: 18-6172.1
• Study Type: interventional
• Target: 1
• Locations: 2 countries
• Sites: 2

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.

Conditions

Stroke; Dysphagia

Keywords

Stroke; Dysphagia; Rehabilitation; Videofluoroscopy

Outcome Measures

Primary Outcomes (4)

• Penetration-Aspiration Scale [PAS]

  Change in swallowing safety on thin and mildly thick liquid swallows. The maximum PAS score per consistency will be collected.

  Pre-treatment baseline, 4 weeks after baseline, 8 weeks after baseline

• Number of swallows per bolus

  Change in swallowing efficiency on thin and mildly thick liquid swallows. The maximum number of swallows per bolus for each consistency will be collected.

  Pre-treatment baseline, 4 weeks after baseline, 8 weeks after baseline

• Pixel-based measurement of post-swallow pharyngeal residue

  Change in swallowing efficiency on thin and mildly thick liquid swallows measured as a % of the C2-C4-squared anatomical reference scalar. The highest value across repeated boluses within a consistency will be collected.

  Pre-treatment baseline, 4 weeks after baseline, 8 weeks after baseline

• International Dysphagia Diet Standardisation Initiative Functional Diet Scale

  Change in diet texture recommendation (number of diet texture levels allowed from the International Dysphagia Diet Standardisation Initiative Framework).

  Pre-treatment baseline, 4 weeks after baseline, 8 weeks after baseline

Secondary Outcomes (5)

• Tongue Strength

  Pre-treatment baseline, 4 weeks after baseline, 8 weeks after baseline

• Saliva Swallow Tongue Pressures

  Pre-treatment baseline, 4 weeks after baseline, 8 weeks after baseline

• Swallow Timing Swallow Timing

  Pre-treatment baseline, 4 weeks after baseline, 8 weeks after baseline

• Hyoid Kinematics

  Pre-treatment baseline, 4 weeks after baseline, 8 weeks after baseline

• Pharyngeal constriction

  Pre-treatment baseline, 4 weeks after baseline, 8 weeks after baseline

Study Arms (2)

Immediate

EXPERIMENTAL

Participants in the immediate intervention arm will begin a 4-week intervention tongue pressure resistance training protocol within 10 days of their baseline Videofluoroscopic Swallowing Evaluation assessment, with 2 face-to-face 1-hour visits per week under direct supervision of a speech-language pathologist. These treatment sessions will be supplemented by daily home practice of the intervention.

Behavioral: Tongue Pressure Resistance Training

Delayed

ACTIVE COMPARATOR

Participants in the delayed intervention arm will begin their involvement with a 4-week waiting period after the baseline Videofluoroscopic Swallowing Evaluation. Treatment will commence after the second Videofluoroscopic Swallowing Evaluation and will follow the same schedule for the tongue pressure resistance training, supplemented by daily home practice.

Behavioral: Tongue Pressure Resistance Training

Interventions

Tongue Pressure Resistance Training BEHAVIORAL

2 supervised sessions per week: Each session will be a maximum of one hour in length and will include: 1) 20 repetitions of maximum isometric presses (MIPs) with rapid rise in pressure at the anterior location. 2) 15 regular saliva swallows with the IOPI bulb in place. 3)15 effortful saliva swallows with the IOPI bulb in place. 4) 10 generalization tasks with mildly thick liquid and IOPI.

Also known as: Iowa Oral Performance Instrument

Delayed; Immediate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Marianjoy Rehabilitation Hospital & Clinics: collaborator

Study Sites (2)

Marianjoy Hospital

Wheaton, Illinois, 60187, United States

Location

Toronto Rehabilitation Institute - University Health Network

Toronto, Ontario, M5G 2A2, Canada

Location

Related Publications (9)

• 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.

  PMID: 29184294 BACKGROUND

• Hori K, Ono T, Iwata H, Nokubi T, Kumakura I. Tongue pressure against hard palate during swallowing in post-stroke patients. Gerodontology. 2005 Dec;22(4):227-33. doi: 10.1111/j.1741-2358.2005.00089.x.

  PMID: 16329231 BACKGROUND

• 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.

  PMID: 27883209 BACKGROUND

• Mann G, Hankey GJ, Cameron D. Swallowing function after stroke: prognosis and prognostic factors at 6 months. Stroke. 1999 Apr;30(4):744-8. doi: 10.1161/01.str.30.4.744.

  PMID: 10187872 BACKGROUND

• Martino R, Foley N, Bhogal S, Diamant N, Speechley M, Teasell R. Dysphagia after stroke: incidence, diagnosis, and pulmonary complications. Stroke. 2005 Dec;36(12):2756-63. doi: 10.1161/01.STR.0000190056.76543.eb. Epub 2005 Nov 3.

  PMID: 16269630 BACKGROUND

• 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.

  PMID: 28282484 BACKGROUND

• 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.

  PMID: 26834320 BACKGROUND

• 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.

  PMID: 17270511 BACKGROUND

• 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.

  PMID: 26936446 BACKGROUND

MeSH Terms

Conditions

Stroke; Deglutition Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Catriona Steele

  KITE - Toronto Rehabilitation Institute - University Health Network

  PRINCIPAL INVESTIGATOR

• Denyse Richardson

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• Michael Pietrantoni

  Marianjoy Hospital

  PRINCIPAL INVESTIGATOR

• Susan Brady

  Marianjoy Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding procedures will be taken to minimize bias - Raters extracting data from VFSS studies will also be blinded to participant allocation, VFSS time-point (pre vs post treatment), time post stroke, and bolus consistency. Each VFSS will be de-identified and converted so that all audio collected during the study will be removed to avoid revealing information to the blinded raters.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized crossover trial

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: May 31, 2019
• Study Start: April 1, 2019
• Primary Completion: June 16, 2022
• Study Completion: June 16, 2022
• Last Updated: June 21, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (1)