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K01 Impacts of Lingual Endurance Exercise

Primary Purpose

Dysphagia, Dysphagia, Oropharyngeal, Ischemic Stroke

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Isotonic Endurance Exercise
Sham Exercise
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysphagia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 1) 3-6 months since most recent diagnosis of ischemic, non-hemorrhagic stroke occurring in areas involving anterior or posterior circulation and affecting underlying cortical or subcortical structures (including brainstem) 2) able to tolerate some oral intake required for assessment of swallowing function via modified barium swallow study (MBSS) 4) able to follow 2-step commands. 3) MBSImP Oral Total (OT) score >10 on Modified Barium Swallow Study (MBSS) Exclusion Criteria: 1) ≤18 years of age 2) 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, surgery involving the pharynx or larynx 3) history of other neurological disease (i.e. multiple sclerosis, ALS, Parkinsons, dementia). 4) Any history of dysphagia from prior stroke will be exclusionary.

Sites / Locations

  • University of CincinnatiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Lingual Endurance Exercise

Sham Exercise

Arm Description

The experimental exercise group will participate in 3 training sessions per day for 8 weeks. Endurance exercise will include completing isotonic endurance repetitions 3 times a day. Number of repetitions per session will be determined during baseline testing for each participant.

The sham control group will be instructed to press the lingual sensor 30 times at a very low-pressure threshold (1-5 kPa), which will be monitored weekly via device output sent to the study team to avoid use of excessive force that would qualify as exercise (>5 kPa).

Outcomes

Primary Outcome Measures

Modified Barium Swallow Study Impairment Profile Oral Total (MBSImP OT Score)
MBSImP is a validated, standardized tool for assessing oral, pharyngeal, and esophageal swallowing function. We will be using change in OT score (sum of components 1-6) as our primary outcome measure.

Secondary Outcome Measures

Normalized Residue Ratio Scale (NRRS)
Measure of swallow efficiency by calculating the amount of residue remaining after a swallow
Penetration Aspiration Scale (PAS) Scores
8-point rating scale that is used to capture both degree and sensation of penetration and aspiration
Adherence
number of repetitions attempted/total number of repetitions prescribed

Full Information

First Posted
September 19, 2023
Last Updated
October 2, 2023
Sponsor
University of Cincinnati
Collaborators
National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT06072924
Brief Title
K01 Impacts of Lingual Endurance Exercise
Official Title
Impact of Lingual Endurance Exercise on Rehabilitation of Swallowing Impairments After Ischemic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
August 31, 2027 (Anticipated)
Study Completion Date
August 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati
Collaborators
National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Swallowing impairments (dysphagia) frequently occur after stroke and have devastating consequences on overall health and quality of life, and long-term deficits in swallow function also increase risk of morbidity (e.g. depression) and mortality (i.e. aspiration pneumonia). As such, rehabilitation of swallow function to improve safety and efficiency of swallowing is essential in this population. This study aims to: 1) Provide preliminary data to evaluate the effect of a novel lingual endurance exercise on swallow function in individuals with post-stroke dysphagia; and 2) Collect preliminary data regarding changes in white matter tract diffusion and cortical thickness and from MRI data to better understand effects of lingual exercise training on neuroplasticity.
Detailed Description
This pilot trial will evaluate the effect of lingual endurance exercise (vs sham exercise) on recovery of swallow function after stroke. The Primary Aim of this study is to evaluate effects of lingual endurance exercise vs sham on swallow function in individuals with post-stroke dysphagia. The investigators hypothesize that lingual endurance training will result in greater improvement in measures of oral swallow physiology as compared to sham. Regardless of outcome, this dataset will provide innovative and highly novel information regarding the relationship between lingual function, swallowing impairments, and cortical representation of dysphagia in a post stroke population. These pilot data will be essential in providing sufficient power for designing an R01 Phase II intervention trial to investigate how to maximize gains with timing and intensity of therapy delivery to better recover swallow function after stroke.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia, Dysphagia, Oropharyngeal, Ischemic Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Sham Controlled
Masking
Participant
Masking Description
Participants will be blinded to condition (experimental vs sham)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lingual Endurance Exercise
Arm Type
Experimental
Arm Description
The experimental exercise group will participate in 3 training sessions per day for 8 weeks. Endurance exercise will include completing isotonic endurance repetitions 3 times a day. Number of repetitions per session will be determined during baseline testing for each participant.
Arm Title
Sham Exercise
Arm Type
Sham Comparator
Arm Description
The sham control group will be instructed to press the lingual sensor 30 times at a very low-pressure threshold (1-5 kPa), which will be monitored weekly via device output sent to the study team to avoid use of excessive force that would qualify as exercise (>5 kPa).
Intervention Type
Behavioral
Intervention Name(s)
Isotonic Endurance Exercise
Intervention Description
Pressing tongue against a pressure sensor at the set number of repetitions per session (individualized per participant) 3 times per day
Intervention Type
Behavioral
Intervention Name(s)
Sham Exercise
Intervention Description
Pressing tongue against pressure sensor at a low threshold (1-5kPa) 30x/day
Primary Outcome Measure Information:
Title
Modified Barium Swallow Study Impairment Profile Oral Total (MBSImP OT Score)
Description
MBSImP is a validated, standardized tool for assessing oral, pharyngeal, and esophageal swallowing function. We will be using change in OT score (sum of components 1-6) as our primary outcome measure.
Time Frame
Change from Baseline (at the end of 8 weeks)
Secondary Outcome Measure Information:
Title
Normalized Residue Ratio Scale (NRRS)
Description
Measure of swallow efficiency by calculating the amount of residue remaining after a swallow
Time Frame
Change from Baseline (at the end of 8 weeks)
Title
Penetration Aspiration Scale (PAS) Scores
Description
8-point rating scale that is used to capture both degree and sensation of penetration and aspiration
Time Frame
Change from Baseline (at the end of 8 weeks)
Title
Adherence
Description
number of repetitions attempted/total number of repetitions prescribed
Time Frame
At the end of 8 weeks
Other Pre-specified Outcome Measures:
Title
Change in fractional anisotropy (FA)
Description
Diffusion Tensor Imaging (DTI) has been the most common analysis framework that is used to analyze the signal from diffusion MRI (dMRI) to gather information about the properties of the underlying white matter.
Time Frame
Change from Baseline (at the end of 8 weeks)
Title
Change in cortical thickness
Description
Diffusion Tensor Imaging (DTI) has been the most common analysis framework that is used to analyze the signal from diffusion MRI (dMRI) to gather information about the properties of the underlying white matter.
Time Frame
Change from Baseline (at the end of 8 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1) 3-6 months since most recent diagnosis of ischemic, non-hemorrhagic stroke occurring in areas involving anterior or posterior circulation and affecting underlying cortical or subcortical structures (including brainstem) 2) able to tolerate some oral intake required for assessment of swallowing function via modified barium swallow study (MBSS) 4) able to follow 2-step commands. 3) MBSImP Oral Total (OT) score >10 on Modified Barium Swallow Study (MBSS) Exclusion Criteria: 1) ≤18 years of age 2) 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, surgery involving the pharynx or larynx 3) history of other neurological disease (i.e. multiple sclerosis, ALS, Parkinsons, dementia). 4) Any history of dysphagia from prior stroke will be exclusionary.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Hopkins, MS
Phone
+1 513 558 4152
Email
hopkiak@ucmail.uc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca Reinert
Phone
+1 513 558 1719
Email
gibsonrk@ucmail.uc.edu
Facility Information:
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Hopkins, MS
Phone
513-558-4152
Email
hopkiak@ucmail.uc.edu
First Name & Middle Initial & Last Name & Degree
Brittany Krekeler, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan currently to share IPD with other researchers.

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K01 Impacts of Lingual Endurance Exercise

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