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Behavioral Intervention

Isotonic Endurance Exercise for Swallowing Difficulty After Stroke

N/A

Recruiting

Led By Brittany N Krekeler, PhD

Research Sponsored by University of Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to follow 2-step commands

Be older than 18 years old

Must not have

History of other neurological disease (i.e. multiple sclerosis, ALS, Parkinsons, dementia)

Any history of dysphagia from prior stroke will be exclusionary

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the end of 8 weeks

Summary

This trial assesses effects of a novel exercise on swallowing after stroke, to improve safety and efficiency and to better understand neuroplasticity.

Who is the study for?

This trial is for adults who have had a stroke within the last 3-6 months, leading to swallowing difficulties. They must be able to take some oral intake and follow commands. It's not for those under 18 or with dysphagia due to other conditions like head injuries, cancer, surgeries affecting throat structures, or neurological diseases.

What is being tested?

The study tests whether a new type of tongue exercise can help improve swallowing after a stroke. Participants will do either real exercises or sham (fake) ones as a comparison. The study also looks at brain changes using MRI scans to understand how the exercises affect recovery.

What are the potential side effects?

Since this trial involves physical exercises and assessments rather than drugs, side effects may include muscle fatigue in the tongue or discomfort from doing the exercises. MRI scans are generally safe but can cause unease in tight spaces.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can understand and follow simple instructions.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of a neurological disease like MS, ALS, Parkinson's, or dementia.

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I have never had swallowing problems due to a stroke.

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I am 18 years old or younger.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the end of 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the end of 8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Modified Barium Swallow Study Impairment Profile Oral Total (MBSImP OT Score)

Secondary study objectives

Adherence

Dietary Intake (Average Daily Calorie Intake) Outcome

Food Textures Consumed Outcome

+4 more

Other study objectives

Change in cortical thickness

Change in fractional anisotropy (FA)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Lingual Endurance ExerciseExperimental Treatment1 Intervention

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, and re-evaluated every 2 weeks, for each participant.

Group II: Sham ExercisePlacebo Group1 Intervention

The sham control group will be instructed to press the lingual sensor 30 times at a very low-pressure threshold (approximately 1-15 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.

0 / 4Eligibility criteria met