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Lingual Endurance Exercise in Treating Post-Stroke Dysphagia

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ClinicalTrials.gov Identifier: NCT05523973
Recruitment Status : Recruiting
First Posted : September 1, 2022
Last Update Posted : September 1, 2022
Sponsor:
Information provided by (Responsible Party):
Brittany Krekeler, University of Cincinnati

Brief Summary:

This study will enroll 15 participants in each exercise condition (groups described below).

Aim 1: Determine feasibility of lingual endurance training for individuals with persistent dysphagia after ischemic stroke. Primary outcome measures: patient adherence (# of attempted repetitions/# prescribed repetitions) and dose delivery (# of repetitions meeting goal/# prescribed repetitions). Aim 2: Determine efficacy of lingual endurance training on improving critical aspects of oropharyngeal swallowing (physiologic impairments, clearance of oropharyngeal residue, airway protection), functional oral intake, and patient reported swallowing quality of life in individuals with persistent dysphagia after ischemic stroke. Primary outcome measures: improvement on videofluoroscopic assessment of swallowing function using the gold standard Modified Barium Swallowing Impairment Profile (MBSImP) Overall Impairment (OI) score and Functional Oral Intake Scale (FOIS) score. Secondary outcome measures: oropharyngeal residue - Normalized Residue Ratio Scale (NRRS); airway invasion - Penetration Aspiration Scale (PAS). Patient reported outcome measures: EAT-10 (Eating Assessment Tool) and the Swallowing Quality of Life Questionnaire (SWAL-QoL). Aim 3: Determine if lingual endurance training + transference exercise (Exercise Group #2) results in better transference of exercise effects to the aforementioned outcomes of swallow safety and efficiency (in Aim2).


Condition or disease Intervention/treatment Phase
Dysphagia, Oral Phase Stroke, Ischemic Other: Lingual Endurance Exercise Other: Lingual Endurance + Transference Exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized (using REDCap) into either the Lingual Endurance Training only (Group 1) or Lingual Endurance + Transference Exercise (Group 2)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Lingual Endurance Exercise on Rehabilitation of Swallowing Impairment After Ischemic Stroke
Actual Study Start Date : August 2, 2022
Estimated Primary Completion Date : August 1, 2023
Estimated Study Completion Date : August 1, 2023


Arm Intervention/treatment
Experimental: Lingual Endurance Training Only (Group 1)
Intervention group 1 will complete lingual endurance training only.
Other: Lingual Endurance Exercise
Participants will participate in 3 training sessions per day for 8 weeks. Group 1 will complete 3 sessions of lingual endurance exercise. For example, if the participant completed 100 repetitions during the baseline measurement, they would complete 75 repetitions during their exercise session.

Experimental: Lingual Endurance Training + Transference Exercise (Group 2)
Intervention Group 2 will complete lingual endurance exercise plus a transference exercise.
Other: Lingual Endurance Exercise
Participants will participate in 3 training sessions per day for 8 weeks. Group 1 will complete 3 sessions of lingual endurance exercise. For example, if the participant completed 100 repetitions during the baseline measurement, they would complete 75 repetitions during their exercise session.

Other: Lingual Endurance + Transference Exercise
Group 2 will complete lingual endurance exercise for 2 sessions, and for the 3rd training session participants will complete 30 swallows where they are instructed to press their tongue hard on the bulb and swallow their saliva. The TongueometerTM will provide biofeedback on performance and will be instructed to generate more pressure during this "effortful swallow" than during a natural, saliva swallow.




Primary Outcome Measures :
  1. Adherence [ Time Frame: Assessed at 8 weeks (study completion) ]
    total number of days of attempted exercise/total number of days prescribed over 8 weeks of therapy

  2. Dose Delivery [ Time Frame: Assessed at 8 weeks (study completion) ]
    # of repetitions meeting goal/# prescribed repetitions (total for 8 weeks)

  3. Change from Baseline Modified Barium Swallowing Impairment Profile (MBSImP) Oral Total Score [ Time Frame: Change from Baseline ]
    Improvement on Oral Total (OT) score MBSImP; OT score minimum score (best) =0; OT maximum score (worst) = 22

  4. Change from Baseline Eating Assessment Tool (EAT-10) Score [ Time Frame: Change from Baseline ]
    patient reported outcome tool; 0 = best score, 50 = worst score


Secondary Outcome Measures :
  1. Change from Baseline Worst Penetration Aspiration Scale (PAS) Score [ Time Frame: Change from Baseline ]
    measure of airway invasion during swallowing, best score = 1, worst score = 8

  2. Change from Baseline in Normalized Residue Ratio Rating (NRRS) [ Time Frame: Change from Baseline ]
    measure of post-swallow residue, % of residue remaining based on total pharyngeal space (normalized per patient)

  3. Change from Baseline in Swallowing Quality of Life Questionnaire (SWAL-QoL) [ Time Frame: Change from Baseline ]
    Patient reported outcome measure of swallowing quality of life, 0 = best score; 100 = worst score

  4. Change from Baseline Functional Oral Intake Scale (FOIS) Score [ Time Frame: Change from Baseline ]
    Measure of oral intake; 7 = best score (total oral intake, no restrictions); 1 = worst score (not safe for oral intake, feeding tube dependent)



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥3 months since initial diagnosis first-time, ischemic, non-hemorrhagic stroke occurring in areas involving anterior or posterior circulation and affecting underlying cortical or subcortical structures (including brainstem)
  • EAT-10 Score of greater than or equal to 3
  • are safe to tolerate some oral intake required for assessment of swallowing function via Modified Barium Swallow Study
  • able to follow 2-step commands
  • English speaking. Participants will not be considered for inclusion if they meet any of the following screening exclusion criteria
  • Final inclusion must include a score of one or greater in any oral or pharyngeal residue score on MBSImP they will qualify for study entry.

Exclusion Criteria:

  • a history of dysphagia prior to or after the stroke caused by any of the following conditions: gastrointestinal disease, traumatic brain injury, head and neck cancer, or a surgical procedure involving the pharynx or larynx
  • a history of other neurological disease including traumatic brain injury, multiple sclerosis, Amyotrophic lateral sclerosis (ALS), Parkinson, or dementia
  • Pregnant women
  • Patients with a history of Temporomandibular joint dysfunction (TMJ) or Epilepsy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05523973


Contacts
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Contact: Brittany Krekeler, PhD 15132272759 krekelby@ucmail.uc.edu
Contact: Anna Hopkins, MS 513-479-6439 hopkiak@ucmail.uc.edu

Locations
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United States, Ohio
Medical Sciences Building Recruiting
Cincinnati, Ohio, United States, 45220
Contact: Brittany Krekeler, PhD    513-227-2759    krekelby@ucmail.uc.edu   
Contact: Anna Hopkins, MS    513-479-6439    hopkiak@ucmail.uc.edu   
Principal Investigator: Brittany Krekeler, PhD         
Sub-Investigator: Stacie Demel, MD, PhD         
Sponsors and Collaborators
University of Cincinnati
Investigators
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Principal Investigator: Brittany Krekeler, PhD University of Cincinnati, Department of Otolaryngology-Head and Neck Surgery
Publications:

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Responsible Party: Brittany Krekeler, Assistant Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT05523973    
Other Study ID Numbers: 2022-0218
First Posted: September 1, 2022    Key Record Dates
Last Update Posted: September 1, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Brittany Krekeler, University of Cincinnati:
swallowing
dysphagia
sub-acute stroke
tongue
exercise
Additional relevant MeSH terms:
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Deglutition Disorders
Stroke
Ischemic Stroke
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