Condition or disease | Intervention/treatment | Phase |
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Stroke Dysphagia | Behavioral: Tongue Pressure Resistance Training | Not Applicable |
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).
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Intervention Model Description: | Randomized crossover trial |
Masking: | Single (Outcomes Assessor) |
Masking Description: | 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. |
Primary Purpose: | Treatment |
Official Title: | Tongue Pressure Resistance Training for Swallowing Impairment Post-Stroke |
Actual Study Start Date : | April 1, 2019 |
Estimated Primary Completion Date : | August 2021 |
Estimated Study Completion Date : | August 2021 |
Arm | Intervention/treatment |
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Experimental: Immediate
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.
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Behavioral: Tongue Pressure Resistance Training
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.
Other Name: Iowa Oral Performance Instrument
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Active Comparator: Delayed
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.
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Behavioral: Tongue Pressure Resistance Training
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.
Other Name: Iowa Oral Performance Instrument
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Illinois | |
Marianjoy Hospital | |
Wheaton, Illinois, United States, 60187 | |
Canada, Ontario | |
Toronto Rehabilitation Institute - University Health Network | |
Toronto, Ontario, Canada, M5G 2A2 |
Principal Investigator: | 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 |
Tracking Information | |||||||||||||
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First Submitted Date ICMJE | May 3, 2019 | ||||||||||||
First Posted Date ICMJE | May 31, 2019 | ||||||||||||
Last Update Posted Date | April 2, 2021 | ||||||||||||
Actual Study Start Date ICMJE | April 1, 2019 | ||||||||||||
Estimated Primary Completion Date | August 2021 (Final data collection date for primary outcome measure) | ||||||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
Change History | |||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||
Descriptive Information | |||||||||||||
Brief Title ICMJE | Tongue Pressure Resistance Training for Swallowing Impairment Post-Stroke | ||||||||||||
Official Title ICMJE | Tongue Pressure Resistance Training for Swallowing Impairment Post-Stroke | ||||||||||||
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). |
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Study Type ICMJE | Interventional | ||||||||||||
Study Phase ICMJE | Not Applicable | ||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Intervention Model Description: Randomized crossover trial Masking: Single (Outcomes Assessor)Masking Description: 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. Primary Purpose: Treatment
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Condition ICMJE |
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Intervention ICMJE | Behavioral: Tongue Pressure Resistance Training
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.
Other Name: Iowa Oral Performance Instrument
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||
Recruitment Status ICMJE | Suspended | ||||||||||||
Estimated Enrollment ICMJE |
40 | ||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||
Estimated Study Completion Date ICMJE | August 2021 | ||||||||||||
Estimated Primary Completion Date | August 2021 (Final data collection date for primary outcome measure) | ||||||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
Listed Location Countries ICMJE | Canada, United States | ||||||||||||
Removed Location Countries | |||||||||||||
Administrative Information | |||||||||||||
NCT Number ICMJE | NCT03969095 | ||||||||||||
Other Study ID Numbers ICMJE | 18-6172.1 | ||||||||||||
Has Data Monitoring Committee | No | ||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Catriona Steele, University Health Network, Toronto | ||||||||||||
Study Sponsor ICMJE | University Health Network, Toronto | ||||||||||||
Collaborators ICMJE | Marianjoy Rehabilitation Hospital & Clinics | ||||||||||||
Investigators ICMJE |
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PRS Account | University Health Network, Toronto | ||||||||||||
Verification Date | March 2021 | ||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |